Rules & Policies Agenda for Board Meeting June 9, 2021

30 E. Broad St., 3rd Floor Columbus, Ohio 43215 (614) 466-3934 www.med.ohio.gov

A. Rule Review Update

B. Podiatric Scope of Practice

C. Light-Based Medical Device Rules

D. Telehealth Discussion

E. Legislative Update

30 E. Broad St., 3rd Floor Columbus, Ohio 43215 (614) 466-3934 www.med.ohio.gov

MEMORANDUM

TO: Betty Montgomery, Acting President Members, State Medical Board of Ohio

FROM: Kimberly C. Anderson, Chief Legal Counsel

RE: Rule Review Update

DATE: May 28, 2021

Attached please find the updated rule review schedule and spreadsheet.

Requested Action: No action requested.

Legal Dept. Rules Schedule As of 5/28/21

RULES AT CSI RULES AT JCARR

Comment Deadline 10/19/20

4731-11-03 4731-11-04 4731-11-04.1 Hearing held 5/17/21: TBR status to consider comments: Comment Deadline 5/14/21 4731-18-01 4731-18-02 4731-18-03 4730-1-07 4730-2-07 4731-35-01 4731-18-04 4731-35-02 JCARR jurisdiction ends 6/13/21:

Hearing Rules

RULES SENT FOR INITIAL CIRCULATION 4731-13-01 4731-13-03 4731-13-06 4731-13-07 4731-13-07.1 4731-13-08 Comment Deadline 5/17/21 4731-13-09 4731-13-13 4731-13-15 4731-6-05 4731-13-16 4731-13-17 4731-13-33 4731-13-36 Comment Deadline 9/25/20 4731-6-14 Dietetics Rules

4759-4-04 4759-4-08 4759-6-02 Rules Ready For Initial Circulation Hearing to be held – 6/28/21 4731-1-01 4731-1-02 4731-1-03 4731-11-11 4731-14-01 4731-23-02 4731-26-01 4731-26-02 4731-26-03 4731-1-04 4731-1-05 4731-1-07

4731-1-08 4731-1-09 4731-1-10 No Change Rules-Filed 4-12-21 – JCARR jurisdiction 4731-1-11 4731-1-12 4731-1-15 ends 7/11/21 4731-1-16 4731-1-17 4731-1-18 4731-13 – Hearing Rules (23) 4731-1-19 4731-22-07 4731-30-03 4731-36-01 4731-16-02 4731-16-05 No Change Rules-Filed 5-27-21 – JCARR jurisdiction 4731-16-08 ends 8/25/21 4731-11-02 4731-11-07 4731-11-08

4731-23-01 4731-23-03 4731-23-04

Rules Needing Amendments Due to HB442

The following rules need to be amended or

rescinded to remove references to cosmetic therapy and oriental medicine:

4731-16-01 Impaired Practitioners Definitions 4731-16-18 Eligibility for one-bite program

Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI

No change 4730‐1‐01 Regulation of Physician Assistants ‐ Definitions 06/12/19 07/16/19 11/07/19 06/18/20 rule 09/16/20 06/18/25 No change 4730‐1‐05 Quality Assurance System 06/12/19 07/16/19 11/07/19 06/19/20 rule 09/17/20 06/19/25 4730‐1‐06 Licensure as a physician assistant 03/22/19 06/12/19 12/04/19 06/18/20 07/23/20 08/17/20 09/09/20 12/31/20 09/30/23 4730‐1‐07 Miscellaneous Provisions 01/25/21 04/14/21 04/26/21 09/30/20 09/30/23 Physician Delegated Prescriptive Authority ‐ No change 4730‐2‐01 Definitions 06/12/19 07/16/19 11/07/19 06/18/20 rule 09/18/20 06/18/25 Period of on‐site supervision of physician‐ 4730‐2‐04 delegated prescriptive authority 06/12/19 07/16/19 11/07/19 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 11/15/23 Addition of valid prescriber number after 4730‐2‐05 initial licensure 06/12/19 07/16/19 11/07/19 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/23 4730‐2‐07 Standards for Prescribing 01/25/21 04/14/21 04/26/21 09/30/20 09/30/25

4730‐2‐10 Standards and Procedures for use of OARRS 06/12/19 07/16/19 11/07/19 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/23 4730‐4‐01 Definitions 05/09/19 11/15/19 05/20/20 06/18/20 07/23/20 08/17/20 10/14/20 10/31/20 04/30/24 Standards and procedures for withdrawal 4730‐4‐02 management for drug or alcohol addition 05/09/19 11/15/19 05/20/20 06/18/20 07/23/20 08/17/20 10/14/20 10/31/20 10/31/25

4730‐4‐03 Office Based Treatment for Opioid addiction 04/30/19 04/30/24 Medication assisted treatment using 4730‐4‐04 naltrexone 04/30/19 04/30/24 4730‐5‐01 new rules re consult rules 4730‐5‐02 4731‐1‐01 Limited Practitioners ‐ Definition of Terms 03/30/20 03/30/25 Application of Rules Governing Limited 4731‐1‐02 Branches of Medicine or Surgery 07/31/19 07/31/24 4731‐1‐03 General Prohibitions 08/31/23 4731‐1‐04 Scope of Practice: Mechanotherapy 12/31/18 12/31/23 Refiled 8/20/19 4731‐1‐05 Scope of Practice: Massage Therapy 04/24/19 4/29/19 06/05/19 10/16/19 11/05/19 11/05/24 4731‐1‐06 Scope of Practice: Naprapathy 08/31/18 08/31/23 Eligibility of Electrologists Licensed by the Ohio State Board of Cosmetology to Obtain Licensure as Cosmetic Therapists Pursuant to Chapter 4731 ORC and Subsequent 4731‐1‐07 Limitations 12/31/18 12/31/23 Continuing Cosmetic Therapy Education Requirements for Registration or Reinstatement of a License to Practice 4731‐1‐08 Cosmetic Therapy 09/30/19 09/30/24

4731‐1‐09 Cosmetic Therapy Curriculum Requirements 08/31/23 4731‐1‐10 Distance Education 01/31/19 01/31/24 Application and Certification for certificate to 4731‐1‐11 practice cosmetic therapy 03/30/20 03/30/25 4731‐1‐12 Examination 11/30/16 11/30/21 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI Determination of Standing of School, College 4731‐1‐15 or Institution 12/31/18 12/31/23 Massage Therapy curriculum rule (Five year 4731‐1‐16 review) 01/31/19 11/30/21 4731‐1‐17 Instructional Staff 05/31/19 05/31/24

Grounds for Suspension, Revocation or Denial 4731‐1‐18 of Certificate of Good Standing, Hearing Rights 03/30/20 03/30/25

4731‐1‐ 19 Probationary Status of a limited branch school 03/30/20 03/30/25 4731‐1‐24 Massage Therapy Continuing Education 03/09/16 10/26/16 04/24/19 04/29/19 06/05/19 Withdrawn 8/30/19 4731‐2‐01 Public Notice of Rules Procedure 12/07/17 12/07/22 4731‐4‐01 Criminal Records Checks ‐ Definitions 09/30/19 09/30/24 4731‐4‐02 Criminal Records Checks 09/30/19 09/30/24 4731‐5‐01 Admission to Examinations 06/09/17 06/09/22

4731‐5‐02 Examination Failure; Inspection and Regrading 06/09/17 06/09/22 4731‐5‐03 Conduct During Examinations 06/09/17 06/09/22 4731‐5‐04 Termination of Examinations 06/09/17 06/09/22

4731‐6‐01 Medical or Osteopathic Licensure: Definitions 07/31/19 07/31/24 Preliminary Education for Medical and 4731‐6‐02 Osteopathic Licensure 07/31/19 07/31/24 Demonstration of proficiency in spoken 4731‐6‐04 English 06/09/17 06/09/22 Format of Medical and Osteopathic 4731‐6‐05 Examination 07/31/19 07/31/24 4731‐6‐14 Examination for physician licensure 09/03/20 07/31/19 07/31/24 Eligibility for Licensure of National Board Diplomats and Medical Council of Canada 4731‐6‐15 Licentiates 07/31/19 07/31/24 Application Procedures for Certificate Issuance; Investigation; Notice of Hearing 4731‐6‐21 Rights 07/31/19 07/31/24 Abandonment and Withdrawal of Medical and 4731‐6‐22 Osteopathic Licensure Applications 07/31/19 07/31/24 4731‐6‐30 Training Certificates 07/31/19 07/31/24 Limited Preexamination Registration and 4731‐6‐31 Limited Certification 07/31/19 07/31/24 4731‐6‐33 Special Activity Certificates 07/31/19 07/31/24 4731‐6‐34 Volunteer's Certificates 07/31/19 07/31/24 4731‐7‐01 Method of Notice of Meetings 07/31/19 07/31/24 4731‐8‐01 Personal Information Systems 04/29/20 10/05/20 11/18/20 02/11/21 no change 02/11/21 02/11/26 4731‐8‐02 Definitions 04/29/20 10/05/20 11/18/20 02/11/21 no change 02/11/21 02/11/26 Procedures for accessing confidential personal 4731‐8‐03 information 04/29/20 10/05/20 11/18/20 02/11/21 no change 02/11/21 02/11/26 Valid reasons for accessing confidential 4731‐8‐04 personal information 04/29/20 10/05/20 11/18/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4731‐8‐05 Confidentiality Statutes 04/29/20 10/05/20 11/18/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI Restricting & Logging access to confidential 4731‐8‐06 personal information 04/29/20 10/05/20 11/18/20 02/11/21 no change 02/11/21 02/11/26 Record of Board Meetings; Recording, Filming, 4731‐9‐01 and Photographing of Meetings 09/15/19 06/17/24 Revised filing 11/3/20 4731‐10‐01 Definitions 10/25/19 05/26/20 10/30/20 12/04/20 12/07/20 05/12/21 05/31/21 05/31/26 Revised Requisite Hours of Continuing Medical filing Education for License Renewal or 11/3/20 4731‐10‐02 Reinstatement 10/25/19 05/26/20 10/30/20 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 Revised filings 11/24 & 11/3 ‐ orig 4731‐10‐03 CME Waiver 10/25/19 05/26/20 10/30/20 12/04/20 12/07/20 05/12/21 05/31/21 05/31/26 Revised filings 11/24 & Continuing Medical Education Requirements 11/3 ‐ orig 4731‐10‐04 for Restoration of a License 10/25/19 05/26/20 10/30/20 12/04/20 12/07/20 05/12/21 05/31/21 05/31/26 Revised filings 11/24 & 11/3 ‐ orig 4371‐10‐08 Evidence of Continuing Medical Education 10/25/19 05/26/20 10/30/20 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 corrected‐ Controlled substances; General Provisions 7/16/20 4731‐11‐01 Definitions 11/14/19 6/18/2020 07/23/20 08/17/20 10/14/20 10/31/20 10/31/25 4731‐11‐02 Controlled Substances ‐ General Provisions 07/26/19 11/13/19 10/05/20 05/27/21 no change 05/27/26

4731‐11‐03 Schedule II Controlled Substance Stimulants 07/26/19 11/13/19 10/05/20 12/31/15 12/31/20 Controlled Substances: Utilization for Weight 4731‐11‐04 Reduction 07/26/19 11/13/19 10/05/20 02/29/16 02/28/21 Controlled substances: Utilization for chronic 4731‐11‐04.1 weight management 07/26/19 11/13/19 10/05/20 12/31/15 12/31/20 4731‐11‐07 Research Utilizing Controlled Substances 07/26/19 11/13/19 10/05/20 05/27/21 no change 05/27/26 Utilizing Controlled Substances for Self and 4731‐11‐08 Family Members 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 no change 05/27/26 Prescribing to persons the physician has never 4731‐11‐09 personally examined. 03/23/17 03/23/22

Standards and procedures for review of "Ohio 4731‐11‐11 Automated Rx Reporting System" (OARRS). 07/26/19 11/13/19 10/05/20 05/27/21 06/28/21 12/31/15 12/31/20

4731‐11‐13 Prescribing of Opioid Analgesics for Acute Pain 08/31/17 08/31/22 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI corrected‐ 7/16/20 4731‐11‐14 Prescribing for subacute and chronic pain 3/21/19 11/14/19 6/18/2020 07/23/20 08/17/20 10/14/20 10/31/20 12/23/23 Preliminary Education for Licensure in 4731‐12‐01 Podiatric Medicine and Surgery 06/30/17 06/30/22 Standing of Colleges of Podiatric Surgery and 4731‐12‐02 Medicine 06/30/17 06/30/22 Eligibility for the Examination in Podiatric 4731‐12‐03 Surgery and Medicine (see note below) 04/19/17 04/19/22 Eligibility of Licensure in Podiatric Medicine and Surgery by Endorsement from Another 4731‐12‐04 State 06/30/17 06/30/22 Application Procedures for Licensure in Podiatric Medicine and Surgery, Investigation, 4731‐12‐05 Notice of Hearing Rights. 06/30/17 06/30/22 4731‐12‐06 Visiting Podiatric Faculty Certificates 06/30/17 06/30/22 4731‐12‐07 Podiatric Training Certificates 06/30/17 06/30/22 Conduct of Hearings ‐ Representative; 4731‐13‐01 Appearances 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐13‐02 Filing Request for Hearing 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 No change 04/12/26 amended filing 1/6/21 4731‐13‐03 Authority and Duties of Hearing Examiners 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 09/30/18 07/31/21 4731‐13‐04 Consolidation 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐05 Intervention 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐06 Continuance of Hearing 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 09/30/16 09/30/21 4731‐13‐07 Motions 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 09/30/18 04/21/21 Form and page limitations for briefs and 4731‐13‐07.1 memoranda 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 09/30/18 09/30/23 4731‐13‐08 Filing 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐13‐09 Service 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐13‐10 Computation and Extension of Time 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐11 Notice of Hearings 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐12 Transcripts 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐13 Subpoenas for Purposes of Hearing 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐13‐14 Mileage Reimbursement and Witness Fees 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐15 Reports and Recommendations 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐13‐16 Reinstatement or Restoration of Certificate 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 Settlements, Dismissals, and Voluntary 4731‐13‐17 Surrenders 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 04/21/16 04/21/21 4731‐13‐18 Exchange of Documents and Witness Lists 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 Depositions in Lieu of Live Testimony and 4731‐13‐20 Transcripts in place of Prior Testimony 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐20.1 Electronic Testimony 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐21 Prior Action by the State Medical Board 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐22 Stipulation of Facts 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐23 Witnesses 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐24 Conviction of a Crime 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI 4731‐13‐25 Evidence 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 Broadcasting and Photographing 4731‐13‐26 Administrative Hearings 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐27 Sexual Misconduct Evidence 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐28 Supervision of Hearing Examiners 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐30 Prehearing Conference 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐31 Transcripts of Prior Testimony 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐32 Prior Statements of the Respondent 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐33 Physician's Desk Physician 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 04/21/16 04/21/21 4731‐13‐34 Ex Parte Communication 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐35 Severability 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 no change 04/12/26 4731‐13‐36 Disciplinary Actions 08/26/20 10/14/20 10/23/20 04/02/21 04/12/21 05/17/21 07/31/16 07/31/21 4731‐14‐01 Pronouncement of Death 01/25/21 03/10/21 03/18/21 05/27/21 06/28/21 06/30/21

4731‐15‐01 Licensee Reporting Requirement; Exceptions 11/17/17 11/17/22 4731‐15‐02 Healthcare Facility Reporting Requirement 11/17/17 11/17/22 4731‐15‐03 Malpractice Reporting Requirement 11/17/17 11/17/22 4731‐15‐04 Professional Society Reporting 11/17/17 11/17/22 Liability; Reporting Forms; Confidentially and 4731‐15‐05 Disclosure 11/17/17 11/17/22

Rules governing impaired physicians and 4731‐16‐01 approval of treatments programs ‐ Definitions 11/17/17 11/17/22 4731‐16‐02 General Procedures in Impairment Cases 11/17/17 11/17/22 4731‐16‐04 Other Violations 11/17/17 11/17/22 4731‐16‐05 Examinations 11/17/17 11/17/22 Consent Agreements and Orders for 4731‐16‐06 Reinstatement of Impaired Practitioners 11/17/17 11/17/22 4731‐16‐07 Treatment Provider Program Obligations 11/17/17 11/17/22 4731‐16‐08 Criteria for Approval 11/17/17 11/17/22 4731‐16‐09 Procedures for Approval 11/17/17 11/17/22 4731‐16‐10 Aftercare Contracts 11/17/17 11/17/22 Revocation, Suspension, or Denial of 4731‐16‐11 Certificate of Good Standing 11/17/17 11/17/22 4731‐16‐12 Out‐of‐State Impairment Cases 11/17/17 11/17/22 4731‐16‐13 Patient Consent; Revocation of Consent 11/17/17 11/17/22 Caffeine, Nicotine, and Over‐The Counter 4731‐16‐14 Drugs 11/17/17 11/17/22 4731‐16‐15 Patient Rights 11/17/17 11/17/22 4731‐16‐17 Requirements for the one‐bite program 01/31/19 01/31/24 4731‐16‐18 Eligibility for the one‐bite program 01/31/19 01/31/24

4731‐16‐19 Monitoring organization for one‐bite program 01/31/19 01/31/24

4731‐16‐20 Treatment providers in the one‐bite program 01/31/19 01/31/24 4731‐16‐21 Continuing care for the one‐bite program 01/31/19 01/31/24 Exposure‐Prone Invasive Procedure 4731‐17‐01 Precautions ‐ Definitions 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4731‐17‐02 Universal Precautions 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 no change 02/11/26 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI 4731‐17‐03 Hand Washing 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 no change 02/11/26 4731‐17‐04 Disinfection and Sterilization 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26

4731‐17‐05 Handling and Disposal of Sharps and Wastes 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4731‐17‐06 Barrier Techniques 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 no change 02/11/26 4731‐17‐07 Violations 08/26/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4731‐18‐01 Definitions 01/10/18 01/20/20 05/12/20 04/05/21 04/09/21 05/17/21 Chapter 18 rules were 4731‐18‐02 Use of Light Based Medical Devices 01/10/18 01/20/20 05/12/20 04/05/21 04/09/21 05/17/21 05/31/02 06/30/05 reviewed by CSI for Delegation of the Use of Light Based Medical 4731‐18‐03 Devices 01/10/18 01/20/20 05/12/20 04/05/21 04/09/21 05/17/21 06/30/00 06/30/05 anti‐trust. Determination Delegation of phototherapy and 4731‐18‐04 photodynamic therapy 01/10/18 01/20/20 05/12/20 04/05/21 04/09/21 05/17/21 05/31/02 05/31/07 rec'd 12/219 Surgery Privileges of Podiatrist ‐ Definition of 4731‐20‐01 Foot 05/31/18 05/31/23 4731‐20‐02 Surgery: Ankle Joint 05/31/18 05/31/23 4731‐22‐01 Emeritus Registration ‐ Definitions 08/31/17 08/31/22 4731‐22‐02 Application 08/31/17 08/31/22 4731‐22‐03 Status of Registrant 05/12/17 05/12/22 4731‐22‐04 Continuing Education Requirements 05/12/17 05/12/22 4731‐22‐06 Renewal of Cycle of Fees 05/12/17 05/12/22 4731‐22‐07 Change to Active Status 08/31/17 08/31/22 Cancellation of or Refusal to Issue an Emeritus 4731‐22‐08 Registration 05/12/17 05/12/22 4731‐23‐01 Delegation of Medical Tasks ‐ Definitions 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 no change 05/27/26 4731‐23‐02 Delegation of Medical Tasks 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 06/28/21 11/30/16 11/30/21 4731‐23‐03 Delegation of Medical Tasks: Prohibitions 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 no change 05/27/26 4731‐23‐04 Violations 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 no change 05/27/26 4731‐24‐01 Anesthesiologist Assistants ‐ Definitions 07/31/19 07/31/24 4731‐24‐02 Anesthesiologist Assistants; Supervision 07/31/19 07/31/24 Anesthesiologist Assistants; Enhanced 4731‐24‐03 Supervision 07/31/19 07/31/24 4731‐25‐01 Office‐Based Surgery ‐ Definition of Terms 03/01/23 4731‐25‐02 General Provisions 05/31/18 05/31/23 Standards for Surgery Using Moderate 4731‐25‐03 Sedation/Analgesia 05/31/18 08/31/23 Standards for Surgery Using Anesthesia 4731‐25‐04 Services 05/31/18 05/31/23 4731‐25‐05 Liposuction in the Office Setting 03/01/18 03/01/23 4731‐25‐07 Accreditation of Office Settings 05/31/18 05/31/23 4731‐25‐08 Standards for Surgery 09/30/19 09/30/24 4731‐26‐01 Sexual Misconduct ‐ Definitions 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 06/28/21 06/30/16 06/30/21 4731‐26‐02 Prohibitions 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 06/28/21 06/14/16 06/14/21 4731‐26‐03 Violations; Miscellaneous 01/25/21 03/10/21 03/18/21 04/23/21 05/27/21 06/28/21 06/30/16 06/30/21 4731‐27‐01 Definitions 02/04/19 02/02/24

4731‐27‐02 Dismissing a patient from the medical practice 05/31/19 05/31/24 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI Notice of termination of physician employment or physician leaving a practice, selling a practice, or retiring from the practice 4731‐27‐03 of medicine 05/31/19 05/31/24 4731‐28‐01 Mental or Physical Impairment 08/31/17 08/31/22 Eligibility for confidential monitoring program 4731‐28‐02 08/31/18 08/31/23 Participation in the confidential monitoring 4731‐28‐03 program 08/31/18 08/31/23

Disqualification from continued participation 4731‐28‐04 in the confidential monitoring program 08/31/18 08/31/23 Termination of the participation agreement 4731‐28‐05 for the confidential monitoring program 08/31/18 08/31/23 Standards and procedures for operation of a 4731‐29‐01 pain management clinic. 06/30/17 06/30/22 4731‐30‐01 Internal Management Definitions 09/23/18 09/23/23 4731‐30‐02 Internal Management Board Metrics 07/26/19 09/23/18 09/23/23 4731‐30‐03 Approval of Licensure Applications 05/07/20 10/17/19 10/17/24 Requirements for assessing and granting clearance for return to practice or 4731‐31‐01 competition. (concussion rule) 04/10/19 05/13/19 11/30/19 11/30/24 4731‐32‐01 Definition of Terms 09/08/17 09/08/22

4731‐32‐02 Certificate to Recommend Medical Marijuana 09/08/17 09/08/22 4731‐32‐03 Standard of Care 09/08/17 09/08/22 Suspension and Revocation of Certificate to 4731‐32‐04 Recommend 09/08/17 09/08/22 Petition to Request Additional Qualifying 4731‐32‐05 Condtion or Disease 09/08/17 09/08/22 4731‐33‐01 Definitions 05/09/19 11/15/19 05/20/20 06/18/20 07/23/20 08/17/20 10/14/20 10/31/20 04/30/24 Standards and procedures for withdrawal 4731‐33‐02 managment for drug or alcohol addiction 05/09/19 11/15/19 05/20/20 06/18/20 07/23/20 08/17/20 10/14/20 10/31/20 10/31/25

4731‐33‐03 Office‐Based Treatment for Opioid Addiction 04/30/19 04/30/24 Medication Assisted Treatment Using 4731‐33‐04 Naltrexone 04/30/19 04/30/24 Standards and Procedures to be followed by physicians when prescribing a dangerous drug that may be administered by a pharmacist by 4731‐34‐01 injection. 07/31/19 07/31/24 4731‐35‐01 Consult Agreements 01/25/21 04/14/21 04/26/21 10/31/20 10/31/25 4731‐35‐02 Standards for managing drug therapy 01/25/21 04/14/21 04/26/21 10/31/20 10/31/25 Military provisions related to education and 4731‐36‐01 experience requirements for licensure 03/22/19 06/12/19 12/05/19 09/11/20 09/25/20 10/27/20 11/16/20 12/09/20 12/31/20 12/31/25 Military provisions related to renewal of 4731‐36‐02 license and continuing education 03/22/19 06/12/19 12/05/19 09/11/20 09/25/20 10/27/20 11/16/20 12/09/20 12/31/20 12/31/25 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI Processing applications from service members, veterans, or spouses of service 4731‐36‐03 members or veterans. 03/22/19 06/12/19 12/05/19 09/11/20 09/25/20 10/27/20 11/16/20 12/09/20 12/31/20 12/31/25 4731‐36‐04 Temporary license for military spouse 02/11/20 02/12/20 02/14/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4759‐2‐01 Definitions 11/30/19 11/30/24 4759‐4‐01 Applications 11/30/19 11/30/24 4759‐4‐02 Preprofessional experience 08/28/24 4759‐4‐03 Examination 11/30/19 11/30/24 4759‐4‐04 Continuing Education 08/27/19 11/10/20 04/02/21 04/09/21 05/17/21 11/30/19 11/30/24 8/27/19 4759‐4‐08 Limited permit 4/19/18 07/11/18 11/10/20 04/02/21 04/09/21 05/17/21 11/30/19 11/30/24 4759‐4‐09 License certificates and permits 04/19/18 07/11/18 09/25/18 11/30/19 11/30/24 4759‐5‐01 Supervision of persons claiming exemption 08/28/19 08/28/24 4759‐5‐02 Student practice exemption 11/30/19 11/30/24 4759‐5‐03 Plan of treatment exemption 11/30/19 11/30/24 4759‐5‐04 Additional nutritional activities exemption 07/01/24 4759‐5‐05 Distribution of literature exemption 07/01/24 4759‐5‐06 Weight control program exemption 07/01/24 4759‐6‐01 Standards of practice innutrition care 11/30/19 11/30/24 4759‐6‐02 Standards of professional performance 04/19/18 07/11/18 11/10/20 04/02/21 04/09/21 05/17/21 12/18/17 4759‐6‐03 Interpretation of standards 11/30/19 11/30/24 4759‐9‐01 Severability 11/30/19 11/30/24 4759‐11‐01 Miscellaneous Provisions 11/30/19 11/30/24 4761‐2‐03 Board Records 02/28/19 02/28/24 4761‐3‐01 Definition of terms 02/28/19 02/28/24 4761‐4‐01 Approval of educational programs 02/28/19 02/28/24 Monitoring of Ohio respiratory care 4761‐4‐02 educational programs 02/28/19 02/28/24 Waiver of licensing requirements pursuant to division (B) of section 4761.04 or the Revised 4761‐5‐01 Code 04/23/19 06/12/19 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/25 Admission to the Ohio credentialing No change 4761‐5‐02 examination 04/23/19 06/12/19 11/06/19 01/10/20 06/19/20 rule 09/19/20 06/19/25 4761‐5‐04 License application procedure 04/23/19 06/12/19 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/25 Respiratory care practice by No change 4761‐5‐06 polysomnographic technologists 04/23/19 06/12/19 11/06/19 01/10/20 06/18/20 rule 09/18/20 06/18/25 4761‐6‐01 Limited permit application procedure 04/23/19 06/12/19 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 02/28/24 Original license or permit, identification card 4761‐7‐01 or electronic license verification 02/28/19 02/28/24 4761‐7‐03 Scope of respiratory care defined 11/15/23 4761‐7‐04 Supervision 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/25 4761‐7‐05 Administration of medicines 11/15/23 4761‐8‐01 Renewal of license or permits 03/22/19 06/12/19 12/05/19 09/11/20 09/25/20 10/27/20 11/16/20 12/09/20 12/31/20 12/31/25 Defnition of respiratory care continuing 4761‐9‐01 education 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 02/28/24 General RCCE requirements and reporting 4761‐9‐02 mechanism 03/22/19 06/12/19 12/05/19 09/11/20 09/25/20 10/27/20 11/16/20 12/09/20 12/31/20 12/31/25 Activities which do not meet the Ohio RCCE 4761‐9‐03 requirements 02/28/19 02/28/24 Board Sent for New Current Approval CSI recom‐ JCARR Rules JCARR Board Rule Number Rule Description Initial CSI filing Effective Review Notes to File with mendation filing Hearing Hearing Adoption Comment Date Date CSI Refiled Ohio respiratory care law and professional 8/24/20 9/24/20 Look at adding OOA as an 4761‐9‐04 ethics course criteria 11/06/19 01/10/20 6/18/2020 7/23/2020 08/17/20 11/10/20 02/28/24 approving organization

Look at adding OOA as an 4761‐9‐05 Approved sources of RCCE 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 02/28/24 approving organization Auditing for compliance with RCCE 4761‐9‐07 requirements 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/25 4761‐10‐01 Ethical and professional conduct 02/28/19 02/28/24 4761‐10‐02 Proper use of credentials 11/15/23 4761‐10‐03 Providing information to the Board 04/23/19 06/12/19 11/06/19 01/10/20 06/18/20 07/23/20 08/17/20 09/09/20 09/30/20 09/30/25 4761‐15‐01 Miscellaneous Provisions 02/28/19 02/28/24 4774‐1‐01 Definitions 04/29/20 10/14/20 10/23/20 11/24/20 02/11/21 no change 02/11/21 02/11/26 4774‐1‐02 Application for Certificate to Practice 04/29/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4774‐1‐03 Renewal of Certificate to Practice 04/29/20 10/14/20 10/23/20 11/24/20 02/11/21 03/15/21 03/29/21 05/12/21 05/31/21 05/31/26 4774‐1‐04 Miscellaneous Provisions 04/29/20 10/14/20 10/23/20 11/24/20 02/11/21 no change 02/11/21 02/11/26 4778‐1‐01 Definition 01/29/19 01/24/24 4778‐1‐02 Application 04/30/19 04/30/24 4778‐1‐03 Special Activity License 01/24/19 01/24/24 4778‐1‐05 Collaboration Agreement 04/30/19 04/30/24 4778‐1‐06 Miscellaneous Provisions 04/30/19 04/30/24

DRAFT Misbranded Drugs

what had been known as NBPME Parts I, II, and III will now be designated as the American Podiatric NOTE RE: 4731‐12‐ Medical Licensing Examination (APMLE) Parts I, II, 03 for next review and III s

30 E. Broad St., 3rd Floor Columbus, Ohio 43215 (614) 466-3934 www.med.ohio.gov

MEMORANDUM

TO: Betty Montgomery, Acting President Members, State Medical Board of Ohio

FROM: Kimberly C. Anderson, Chief Legal Counsel

RE: Podiatric Scope of Practice

DATE: June 3, 2021

Following the May Board meeting, a letter was provided to Representative Callender, Chair of JCARR advising that the Board voted to pursue this matter through the rule-making process. I was notified today that I do not need to attend the JCARR meeting on June 7, 2021.

Attached please find the documents to start the rule-making process by reaching out to interested parties to obtain comments and information that will assist the staff and the Board in drafting the rule language. Attached you will find a draft notice and attachments to be sent to interested parties and placed on the website. A three week comment period is provided.

The State Medical Board of Ohio is seeking public comments on podiatric scope of practice to assist with its rule-making process.

Under section 121.931,Ohio Revised Code, a party may petition an agency to restate a policy in a rule. In June 2019, the State Medical Board of Ohio considered a request from a podiatrist as to whether five specific procedures were within the scope of practice of a podiatrist. The Board determined that four of the five procedures were within the scope of practice of a podiatrist. After the Board issued its determination on this issue, concerns were raised with respect to two of the specific procedures that were determined to be within the podiatric scope of practice:

1. Is it permissible for a podiatrist in Ohio to perform a supramalleolar osteotomy of the tibia or fibula to correct a deformity?

2. Is it permissible for a podiatrist in Ohio to harvest bone marrow aspirate from the proximal tibia?

In May 2021, the State Medical Board appeared before the Joint Commission on Agency Rule Review (“JCARR”) for consideration as to whether the policy determination should be specified in a rule. Prior to receiving the determination from JCARR, the State Medical Board of Ohio decided to commence the rule-making process on this issue. Given the differences from the affected parties, the Board has decided to first solicit comments from interested parties to inform the rule-making process.

Attached you will find copies of the Medical Board rules related to podiatric scope of practice and the June 2019 communication regarding the specific procedures.

Please provide any comments and supporting material that you would like the Medical Board to consider in drafting rules related to the above-listed specific procedures and whether they are within the scope of practice of a podiatrist.

Comments on the proposed rules must be received no later than July 2, 2021. Please provide comments to: [email protected]

Ohio Administrative Code Rule 4731-20-01 Definition of foot. Effective: May 31, 2018

"Foot," as used in section 4731.51 of theRevised Code, means the terminal appendage of the lower extremity and includesthe ankle joint which consists of the tibial plafond, its posterolateral border(posterior malleolus), the medial malleolus, distal fibula (lateral malleolus)and the talus.

Page 1

Ohio Administrative Code Rule 4731-20-02 Surgery: ankle joint. Effective: May 31, 2018

(A) A podiatric physician may perform surgery on the ankle joint, when both of the following requirements are met:

(1) The podiatric physician holds privileges to perform surgery on the ankle joint from one or more of the following entities:

(a) A college of podiatric medicine and surgery approved bythe board pursuant to section 4731.51 of the Revised Code;

(b) A hospital approved by the "Joint Commission"or the "American Osteopathic Association"; or

(c) An ambulatory surgical facility approved by thedepartment of health pursuant to its authority under Chapter 3702. of theRevised Code; and

(2) The podiatric physician can demonstrate adequate education, training and experience needed to conform to minimal standards of care of similar practitioners under the same or similar circumstances by meeting either of the following criteria:

(a) Having attained board qualified status from the"American Board of Foot and Ankle Surgery" and having successfullycompleted at least a twenty-four month residency in podiatric surgery approvedby the "Council on Podiatric Medical Education," or

(b) Holding privileges to perform surgery on the anklejoint from an institution meeting criteria under paragraph (A)(1) of this rule,providing that such privileges were granted prior to January 30, 1997.

(B) A podiatric physician who performs surgery on the ankle joint other than in accordance with all the terms of this rule violates divisions (B)(6) and (B)(20) of section 4731.22 of the Revised Code.

Page 1 30 E. Broad St., 3rd Floor Columbus, Ohio 43215 (614) 466-3934 www.med.ohio.gov

MEMORANDUM

TO: Betty Montgomery, Acting President Members, State Medical Board of Ohio

FROM: Kimberly C. Anderson, Chief Legal Counsel

RE: Light Based Medical Device Rules

DATE: June 4, 2021

Rules regarding light based medical devices, hearing examiners and dietetics were considered at the May 17, 2021 public hearing. The Board received comments from over 20 individuals and entities. The transcript and hearing report are attached and outline the comments in detail.

Most of the comments received were related to the light based medical device rules, which were scheduled to be heard at the JCARR meeting on Monday, June 7, 2021. The light based medical device rules were placed in To Be Refiled (“TBR”) status, to allow Board members the opportunity to consider the comments and determine whether the rule should be amended. To ensure that the permanent rules can be adopted and in place prior to the expiration of the emergency rule, 4731-18-03, on August 8, 2021, the rules will need to be refiled no later than June 10, 2021. The light based medical device rules will then be on the schedule for the June 28, 2021 JCARR meeting.

The comments generally fall into three groups:

I. Physician Assistants should be able to provide more types of laser treatment. II. Cosmetic therapists with questions about the training, education and supervision requirements or seeking to expand the use of light based medical devices beyond laser hair removal. III. General comments

I. Comments Related to Physician Assistants:

A. Anna Luning, CNP, FNP-C: 4731-18-03(A)(3) and (A)(4): For physician assistants, the step of having the physician see and evaluate the patient to determine whether the proposed application of the specific vascular laser is appropriate and to review following the initial application of the vascular laser is unnecessary and takes away from patient care. The physician assistants are acting as the sole provider responsible for patient care.

Recommendation: No amendment recommended. This was specifically discussed with the Board at the March meeting and it was determined that these steps could be completed via telemedicine, but not eliminated because this is a new service for physician assistants. The

advanced training and education of physician assistants has been taken into account with these rules.

B. Scott Cackler, PA, Chair, PAPC: 4731-18-03(A)(5)(a): remove the words “authorizing the service”. Not necessary to list the services that can be provided in the supervisory agreement.

Recommendation: Amend 4731-18-03 and 4731-18-04, OAC to make this change. See attached changes to 4731-18-03(A)(5)(a), 4731-18-03(B)(5)(a), 4731-18-04(B)(2)(a) and 4731-18-04(C)(2)(a).

C. MONA Dermatology: Paragraphs 4731-18-03(A)(3) and (A)(4) should not apply to physician assistants or nurse practitioners. Requiring examination by a physician disrupts patient care.

Recommendation: See I.A.

D. Stephen Lopez, MD: Physician assistants should be authorized to use high powered wavelength ablative lasers such as CO2 lasers. Proposed rule 4731-18-02 is too restrictive. Physician assistants in other states do not have restrictions for ablative lasers.

Recommendation: No amendment recommended. Currently, physician assistants cannot use any light based medical devices except for laser hair removal, phototherapy and photodynamic therapy. The rules as proposed will allow physician assistants to utilize non-ablative vascular lasers.

E. Dana Domer, PA-C: Physician assistants are able to use laser and light based devices in other states and should be able to use them in Ohio.

Recommendation: No amendment recommended. The proposed rules expand the types of light based medical devices that physician assistants may use.

F. Shannon Urena, PA-C: Physician assistants have extensive training and should be able to use light based medical devices as physicians do.

Recommendation: No amendment recommended. The proposed rules expand the types of light based medical devices that physician assistants may use.

G. Angie Dreimiller, PA-C: Physician assistants are qualified to use a CO2 laser in all 48 states except for Maryland and Ohio.

Recommendation: No amendment recommended. The proposed rules expand the types of light based medical devices that physician assistants may use.

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov H. Serina Abdul Satter, Pre PA student: Physician assistants are qualified to use a CO2 laser and other states allow physician assistants to use CO2 lasers.

Recommendation: No amendment recommended. The proposed rules expand the types of light based medical devices that physician assistants may use.

II. Comments Related to Cosmetic Therapists:

A. Manu Aggarwal, MD: CTs spend close to a year learning hair anatomy for laser hair and electrolysis treatments and are more qualified than other license types to provide laser treatment for hair reduction. He employs a CT, but many CTs work with an offsite medical director. Taking away the ability of trained persons to do these services is taking away their livelihood.

Recommendation: No amendment recommended. The rules retain the requirements for off-site supervision by a physician. There is no change here.

B. Amanda Nelson, Cosmetic Therapy Association of Ohio:

4731-18-01(I): Adjust the off-site supervision definition. Cosmetic therapy small businesses have barriers when it comes to doctors being within 60 minutes from the location. Clients often drive further distances.

Recommendation: See II.A

4731-18-03(A)(5): Allow cosmetic therapists to be added to the list of individuals who can utilize a vascular laser. This was based on a statement from Dr. Bechtel in the December 2020 Policy Committee minutes.

Recommendation: No amendment recommended. This appears to be an error. There is no indication that cosmetic therapists have the training and education to apply vascular lasers.

4731-18-03(A)(7): Add CT education requirements to those for vascular laser delegation.

Recommendation: No amendment recommended. Cosmetic therapy training and education is focused on hair removal. No indication that cosmetic therapists should be added to the licensed professionals who may be delegated the use of vascular laser.

4731-18-03(B)(3) and (4): Tele-presence or telemedicine added and defined: Implement telemedicine guidelines for laser hair removal for off-site supervision.

Recommendation: No amendment recommended. The Board determined that the physician evaluation in these rule sections could be completed via

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov telemedicine and the physician would be subject to minimal standards requirements in other rules, such as Rule 4731-11-09, OAC.

4731-18-03(B)(9): CT to be removed from physician supervision quantity limit. Doctor supervision of no more than two CTs is a barrier to small business. There are only 185 in the profession therefore it is unlikely that a business would have an inappropriate amount of CTs being supervised by only one physician if they were removed from this part of the rule.

Recommendation: No amendment recommended. The limit on supervision is an existing requirement. This is not a change.

4731-18-03(C): Telepresence/telemedicine to be added and defined. Clients who are a Fitzpatrick scale of I-III who are on no medication or only on birth control are at the last risk of complications from laser hair removal and would be the right population to allow for a virtual review of the patient health history and waiving the in-person evaluation of the treatment response for off-site supervision delegation.

Recommendation: No amendment recommended. The off-site supervision requirements for cosmetic therapists are in the current rule. This section applies only to established patients. The Board fully discussed the physician evaluation requirements in section (B)(3) and (4) and determined that they could be completed via telemedicine. Amendments have already been made to those sections to allow for telemedicine review by physicians.

4731-18-04(C)(2), (4), (5), (6): CTs to be added to professionals who may provide photodynamic therapy delegation. Photodynamic therapy can treat conditions of CT clientele also struggle with such as acne and age spots.

Recommendation: No amendment recommended. No indication that CT training and education includes photodynamic therapy.

C. Kelly Wert, Cosmetic Therapist: Would like to have physician be able to supervise more than 2 cosmetic therapists. Allow cosmetic therapists with additional training to be delegated vascular lasers and photodynamic therapy. Supportive of the changes recommended by Amanda Nelson of the Cosmetic Therapy Association of Ohio.

Recommendation: No amendment recommended. There is no indication that cosmetic therapists have the training and education to apply vascular lasers or photodynamic therapy. The supervision limit for two cosmetic therapists is in the current rule.

D. Kristy Good-Bath: Graduated from cosmetic therapy program in October 2020 and purchased business and equipment for laser hair removal. Seeking legislative change as alternate to HB442.

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov Recommendation: No amendment recommended. Legislative change is up to the legislature.

E. Marley Miller: Was a student when HB442 passed and had completed 20 hours of didactic training and 30 hours of clinical laser hair removal. Rule 4731-18-03 requires additional training of 20 procedures of laser observation and 30 procedures with physician supervision. No other states require this amount of training.

Recommendation: Recommend Board discussion of this proposal. The education and training requirements for cosmetic therapists, RNs and LPNs who have not done laser hair removal for two years or more were developed in consultation with Dr. Bechtel and other dermatologists.

F. Marty Sweterlitsch, Benesch Law on behalf of Ohio Society of Cosmetic Therapy Training: Four areas of proposed rule 4731-18-03 provide obstacles for cosmetic therapists.

(1) Probe electrolysis using electric current on face and body is left unregulated.

Recommendation: No amendment recommended. This is outside the scope of the rule and Medical Board regulation.

(2) Required physician involvement in the proposed training for cosmetic therapists is prohibitive in terms of cost and identifying willing physicians. The training process is complicated and expensive and requires active physician involvement. Physicians will not want to put in the time and this will mean that no cosmetic therapist will be able to enter the profession. Proposal is to allow the State Board of Career Colleges and Schools to direct the training and education and provide certification to the physician of completion of curriculum and national testing.

Recommendation: Recommend Board discussion of this proposal. The education and training requirements for cosmetic therapists who have not done laser hair removal for two years or more were developed in consultation with Dr. Bechtel and other dermatologists. This proposal would have the education and training completed during the cosmetic therapist’s initial training rather than on the job with the supervising physician.

(3) Current CT students and inactive CTs are left in limbo: 4731-18-03(B)(7)(e) specifies that delegates who have been applying light based therapy must be active for two years prior to the effective date of the rule.

Recommendation: No amendment recommended. This section allows CT, RN and LPN delegates who have been applying a specific type of light based medical device procedure for hair removal for at least two years to be exempted from the education and training requirements of 4731-18-03(B)(7)(a) through (c).

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov

(4) Off-site supervision should not be limited to 60 minutes travel time. Request that physician be able to meet this requirement through electronic means or telehealth.

Recommendation: No amendment recommended. Rule 4731-18-01(I) defines “off- site supervision” to mean that the supervising physician shall be continuously available for direct communication with the cosmetic therapist and must be in a location that under normal conditions is not more than sixty minutes travel time from the cosmetic therapist’s location. It should be noted that this definition is the same as previously existed in 4731-18-03(E), and therefore is not a new requirement.

G. Vickie Mickey, About Face Cosmetic Therapy Training Center: The training and education requirements of 4731-18-03(B) require cosmetic therapy practices to employ physicians to ensure that the cosmetic therapist has completed the training with observed procedures. The addition of a physician to the laser hair removal training will triple the cost of training. Many patients need electrolysis and laser hair removal both.

Recommendation: No amendment recommended. The additional education and training requirements are not required for cosmetic therapists who were previously licensed and have been performing laser hair removal for the last two years. It is important to note that this rule is about the delegation of a medical procedure and physician delegation and supervision has always been required.

H. Kelly Ott-Statzer: It will be difficult to obtain a physician to ensure that the person they are delegating laser hair removal to is properly trained on the laser. The distance requirement for off-site supervision is problematic if the delegating physician goes out of town, all appointments will have to be canceled. Requiring physician examination prior to application of the laser and after the initial application will delay service to patients because the physicians may only come in twice per month. Recommend communication with physician through telemedicine.

Recommendation: No amendment recommended. The Board allowed for physician examinations to be completed via telemedicine. This rule is about delegating a medical procedure, so having a physician ensure proper education and training prior to delegation is the point of the rule for patient safety. The off-site supervision requirements for cosmetic therapists are unchanged from the current rules.

I. Jeanne Griebling CT: Objects to training for cosmetic therapist being provided at the high school level.

Recommendation: No amendment recommended. This does not appear to be responsive to the proposed rules of the Medical Board.

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov J. Jason Lichten: He questioned why the rule references cosmetic therapists and thought that HB 442 eliminated the ability of cosmetic therapists to do laser hair removal.

Recommendation: No amendment recommended. Rule 4731-18-03 allowed physicians to delegate laser hair removal to cosmetic therapists licensed by the Medical Board. The emergency rule and proposed rule 4731-18-03 allows physicians to delegate to cosmetic therapists who were licensed by the Medical Board as of April 11, 2021 or who meet specified education and training.

III. General comments

A. American Society for Dermatologic Surgery Association, Matthew Avram, MD, JD, President and Emily Besser, Manager of Advocacy and Practice Affairs: Represents over 6400 dermatologic surgeons. Support the rules as common sense regulations that ensure than any light based medical procedures are delegated to the correct individuals and that a physician is on- site at all times to supervise non-physician providers. Recommendation: No amendment recommended.

B. Sean Johnson: General question about the rule-making process.

Recommendation: No amendment recommended.

C. Jen Johns, Ohio Academy of Medicine of Cleveland and Northern Ohio: Believes there should be evidence of appropriate education, training and competency to perform use of light based medical devices regardless of provider type. Asked whether there is any evidence that competency can be achieved with the education and with the observation and performance of procedures under direct oversight.

Recommendation: No amendment recommended. The rules were developed with input from Dr. Bechtel and other dermatologists.

D. Larry Wolpert, Director, Joint Committee on Agency Rule Review: (1) An unnecessary “5” in 4731-18-03(A)(7)(b). (2) Is the meaning of “direct physical oversight” in 4731-18-03(A)(7)(c) that same as “on-site supervision” or is it more observatory? Rule 4731-18-01(H) defines “on-site supervision” as the physical presence of the supervising physician is required in the same location (i.e. the physician’s office suite) as the delegate but does not require the physician’s presence in the same room. “Direct physical oversight” could be defined to require the physician’s presence in the same room as the delegate of the light based medical device. Recommendation: Amendment recommended to correct error. Recommend amendment of 4731-18-01 to add definition of “direct physical oversight” if it differs from on-site supervision or to change the references in to “direct physical oversight” to on-site supervision if it does not differ.

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov Recommended Action: Make amendments as discussed and re-file no later than June 10, 2021. Delegate to Board President for approval of any changes between the June and July meetings.

State Medical Board of Ohio 30 E. Broad St., 3rd Floor  Columbus, Ohio 43215  (614) 466-3934 www.med.ohio.gov

STATE MEDICAL BOARD OF OHIO

RECEIVED: May 26, 2021

SUMMARY OF THE MAY 17, 2021 PUBLIC HEARING REGARDING PROPOSED CHANGES TO THE OHIO ADMINISTRATIVE CODE

Pursuant to Section 119.03, Ohio Revised Code, a public hearing was held on May 17, 2021, to hear comments concerning proposed changes to the administrative rules of the State Medical Board of Ohio (“Board”). Kimberly A. Lee, Hearing Examiner, presided.

PURPOSE OF THE HEARING

The following changes are proposed:

Light Based Medical Devices Rules

Rule No. Title Proposed Action

4731-18-01 Definitions New Rule 4731-18-02 Use of light based medical devices New Rule 4731-18-02 Use of light based medical devices Rescind 4731-18-03 Delegation of the use of light based medical devices for New Rule specified non-ablative procedures. 4731-18-03 Delegation of the use of light based medical devices for Rescind specified non-ablative procedures. 4731-18-04 Delegation of phototherapy and photodynamic therapy New Rule 4731-18-04 Delegation of phototherapy and photodynamic therapy Rescind

Hearing Rules

Rule No. Title Proposed Action

4731-13-01 Representatives; Appearances Amend 4731-13-03 Authority and duties of hearing examiners Amend 4731-13-06 Continuance of hearing Amend 4731-13-07 Motions Amend 4731-13- Form and page limitations for briefs and memoranda Amend 07.1 4731-13-08 Filing Amend 4731-13-09 Service Amend 4731-13-13 Subpoenas for purposes of hearing Amend 4731-13-15 Reports and recommendations Amend 4731-13-16 Reinstatement or restoration of certificate Amend 4731-13-17 Settlements, dismissals, and voluntary surrenders Amend 4731-13-33 “Physicians’ Desk Reference” Amend 4731-13-36 Disciplinary actions Amend Summary of May 17, 2021 Public Rules Hearing Page 2 Case No. 21-PRH-0002

Dietetics Rules

Rule No. Title Proposed Action 4759-4-04 Continuing Education New Rule 4759-4-04 Continuing Education Rescind 4759-4-08 Limited Permit New Rule 4759-4-08 Limited Permit Rescind 4759-6-02 Standards of professional performance Amend

PROCEDURAL MATTERS

1. The record was held open until 5:00 p.m. on May 17, 2021, for the purpose of receiving written comments concerning the proposed changes to the Ohio Administrative Code. Written comments were received from Kelly Ott-Statzer, Dana Domer, MPAS, PA-C, Shannon Urena, M.S., M.S., PA-C, Angelina Dreimiller, PA-C, Serina Abdul Satter, and Jeanne Griebling, CT, and were marked as Exhibits 7-12 respectively.

2. Due to the ongoing Covic-19 emergency, the hearing was conducted via videoconferencing software.

TESTIMONY HEARD

1. Kimberly Anderson, Chief Legal Counsel for the Board 2. Marty Sweterlitsch, Benesch Law, on behalf of the Ohio Society of Cosmetic Therapy Training 3. Mona Foad, M.D., on behalf of MONA Dermatology 4. Amanda Nelson, on behalf of the Cosmetic Therapy Association of Ohio

EXHIBITS EXAMINED

Exhibit 1: Copy of the rules originally filed in Package 189936 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule-Filing System on April 9, 2021, a copy of the confirmation of filing, and a copy of the confirmation of the revised filing on April 16, 2021.

Exhibit 2: Copy of the rules originally filed in Package 190003 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule-Filing System on April Summary of May 17, 2021 Public Rules Hearing Page 3 Case No. 21-PRH-0002

12, 2021, a copy of the confirmation of filing, and copies of the confirmations of revised filings on April 16, 2021 and May 3, 2021.

Exhibit 3: Copy of the rule originally filed in Package 190004 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule-Filing System on April 9, 2021, a copy of the confirmation of filing, and a copy of the confirmation of the revised filing on April 19, 2021.

Exhibit 4: Copy of the Notice of Public Hearing for the rules in Packages 189936, 190003, and 190004 showing it was filed on April 12, 2021; copy of the Notice of Public Hearing refiled on April 16, 2021 for the rules in Packages 189936 and 190003; and a copy of the Notice of Public Hearing refiled on April 19, 2021 for Package 190004.

Exhibit 5: Copies of the address portion of e-mails sent to persons and organizations pursuant to their standing request to be notified when the Medical Board proposes rules.

Exhibit 6: Copies of comments received from received from: Jason Lichten; Jessica Watkins, PA, MONA Dermatology; Jen Johns of The Academy of Medicine of Cleveland and Northern Ohio; Scott Cackler; Kelly Ott-Statzer; Stephen Lopez, M.D.; Kay Mavko, MS, RDN, LD, and Patricia McKnight, MS, RDN, LD, Ohio Academy of Nutrition and Dietetics; Kristine Good- Bath; Anna Luning, CNP, MONA Dermatology; Mona Foad, M.D., MONA Dermatology; Kelly Wert, Cosmetic Therapy Association of Ohio; Manu Aggarwal; Martha Sweterlitsch, Ohio Society of Cosmetic Therapy Training; Vickie Mickey, About Face Cosmetic Therapy Training Center; Vickie Mickey, Cosmetic Therapy Training Center; Marley Miller; Amanda Nelson, Cosmetic Therapy Association of Ohio; and Emily Besser, MA, CAE, and Mathew Avram, M.D., J.D., American Society for Dermatologic Surgery Association.

Exhibit 7: Comment from Kelly Ott-Statzer

Exhibit 8: Comment from Dana Domer, MPAS, PA-C

Exhibit 9: Comment from Shannon Urena, M.S., M.S., PA-C

Exhibit 10: Comment from Angelina Dreimiller, PA-C

Exhibit 11: Comment from Serina Abdul Satter

Exhibit 12: Comment from Jeanne Griebling, CT

SUMMARY OF EVIDENCE

1. Kimberly Anderson, Chief Legal Counsel for the Board, identified Exhibits 1 through 6. She further testified with respect to the notice that the Board provided to the public and Summary of May 17, 2021 Public Rules Hearing Page 4 Case No. 21-PRH-0002

interested parties regarding the proposed rule changes, and with respect to other procedural matters. (Hearing Transcript (“Tr.”) at 8-11)

2. There were no comments on the Board’s proposed hearing rules.

3. Kay Mavko, MS, RDN, LD, and Patricia McKnight, MS, RDN, LD, of the Ohio Academy of Nutrition and Dietetics were the only ones to comment in regard to the proposed dietetics rules. They were in support of the proposed new rules and amendment and thanked Nathan Smith and Jill Reardon for their work and cooperation. (Exhibit (“Ex.”) 6 at 26)

4. Jason Lichten questioned why the proposed rules for the use of light based medical devices still referenced cosmetic therapists (“CTs”) if H.B. 442 eliminated their ability to perform laser hair removal. (Ex. 6 at 1)

5. Jessica Watkins, PA-C, of MONA Dermatology, commented that the proposed rules require that physician assistants (“PAs”) have significant physician oversight including pre- and post-procedure evaluations. Ms. Anderson responded and informed her that the Board had considered this issue and determined that initial physician evaluations could be performed via telemedicine for proposed rules 4731-18-03(A)(3), (A)(4), (B)(3), and (B)(4). Ms. Anderson further replied that the Board also determined that initial physician reviews prior to delegating a phototherapy and photodynamic therapy pursuant to proposed rule 4731-18-04(B)(2) and (C)(2) could also be done via telemedicine and that the reviews were not necessary for PAs. (Ex. 6 at 5-14)

6. Jen Jones, MPH, Executive Director of The Academy of Medicine of Cleveland & Northern Ohio, commented that “there should be evidence of appropriate education, training, and competency to perform them regardless of provider type.” She also asked if there was any evidence that the procedure numbers and education hours were “appropriate for achieving competency” for registered nurses (“RNs”), licensed practical nurses (“LPNs”), and CTs to perform vascular laser non-ablative procedures. (Ex. 6 at 15-16)

7. Scott Cackler commented:

My only question about light based code was in 4731-18-03(B)5a to remove “authorizing the service”. Those 3 words at the end seems like the SA must reference light based therapy. This is repeated a few other times in the code when referring to SA's. I don't think the intent is to add a list of things can and can't do to the SA but to verify that light based therapy is something you and your supervising physician are comfortable with the PA performing under their SA but not actually listing it on the SA.

(Ex. 6 at 17-18) Summary of May 17, 2021 Public Rules Hearing Page 5 Case No. 21-PRH-0002

8. Kelly Ott-Statzer, an unlicensed CT, posed a number of questions and concerns in her her original comment. In summary, she wrote:

Will the proposed new rules require CTs, RNs, and LPNs to train with every new physician and every device they work with regardless of whether they were previously or newly licensed? She was also concerned that it would be difficult and costly to locate a physician willing participate in the observation and performance of the required number of procedures, especially considering that four different wavelengths could be used for hair removal.

How will the exemption from the training and education requirements for delegates who have been performing laser hair removal would apply in instances where delegates had not been with their current delegating physician for at least two years even though the delegates had been performing laser hair removal for more than two years?

How long does the requirement for on-site supervision in proposed rule 4731-18-03(B)(8) remain in effect? How does this work with the off- site supervision provision in proposed rule 4731-18-03(C)?

Can telemedicine be utilized in regard to this rule? Given the pandemic, telemedicine limits exposure and allows for off-site communication.

The distance restriction will require CTs to cancel all of their appointments if the delegating physician goes out of town and thereby deprives the CTs of income.

(Ex. 6 at 20-23)

After the hearing, Ms. Ott-Statzer submitted an additional comment. She noted that the minimum distance restriction would essentially require CTs to cancel all appointments, and lose income, if the physician went out of town. She also noted that the on-site supervision requirement during consultations and test spots will limit CTs to certain days and prevent them from beginning treatment immediately. In closing, Ms. Ott-Statzer wrote:

We are the only profession that can perform permanent hair removal and we need the laser to accomplish that efficiently and effectively These added regulations not only hurt us by shutting us out of the marketplace, but they hurt the consumer who seeks out our expertise. These new regulations prohibit healthy competition in the marketplace. We need laser hair removal to effectively and efficiently perform permanent hair removal.

(Ex. 7) Summary of May 17, 2021 Public Rules Hearing Page 6 Case No. 21-PRH-0002

9. Stephen Lopez, M.D., is a plastic surgeon who has been collaborating with a PA for more than a year. Dr. Lopez wrote that, in regard to high wavelength laser and CO2 laser procedures, Rule 4731-18-02 inhibited patient care, made physicians unable to timely treat patients, and financially affected physicians. He also stated that other states do not have the restrictions that Ohio does and provide for the use of such lasers by advanced practicing providers. Dr. Lopez has worked with advanced practicing providers on ablative procedures in other states and did not experience an increase in complications. He also wrote, “I have the utmost confidence that a board-certified PA is qualified to utilize and operate high powered laser, such as a CO2 laser for ablative procedures.” (Ex. 6 at 24-25)

10. Kristine Good-Bath, owner of Bella Cosmedica, wrote that she had completed training in cosmetic therapy in October 2020, purchased the necessary equipment to begin offering hair removal services, and found a physician to supervise laser hair removal treatments. She then learned of the passage H.B. 442 which has been a professional and financial blow. She stated that she, along with others, drafted an alternative to H.B. 442 and asked that it be considered. However, the alternative was not included with her impact statement. (Ex. 6 at 34)

11. Mona Foad, M.D., Jessica Watkins, PA-C, Megan Niese, PA-C, and Anna Luning, CNP, of MONA Dermatology, commented regarding the requirements in proposed rule 4731-18-03 (A)(3) and (A)(4). They wrote that PAs and NPs are often the principal care provider, and that the proposed rule limits their ability to efficiently provide care. They provided the examples of a pulse dye laser in the treatment of warts and intense pulse light and laser treatment for the treatment of rosacea which may be used by a physician or NP but not a PA. They claim that such restrictions undermine patient confidence in PAs and increase patient inconvenience. They also wrote that the PAs and NPs should not have different requirements though they understand the requirements being imposed on LPNs and CTs. In addition, they wrote, “Considering PAs routinely perform procedures that carry far greater risks such as surgical excisions, chest tube placement, central lines and tracheostomies, the need to appoint higher standards of oversight for light based therapies is baseless.” Finally, they expressed their belief that the proposed rule is not in line with existing statutes regarding supervision, delegation, and training. (Ex. 6 at 41-42) Ms. Luning also provided a separate comment that echoed many of these points. (Ex. 6 at 25-36)

12. In addition to her written comment, Dr. Foad also spoke at the hearing. She stated that she had employed PAs and NPs for the last 19 years and trained them in dermatology. As in her written comment, she stated that it would increase patient care if PAs could use pulse dye lasers for warts and light based treatment for rosacea and that a PAs inability to do so impacted the patient’s confidence in the PA as a treatment provider. Dr. Foad expressed that she did not understand why PAs were limited when NPs were not and further stated that PAs should not be included in the same category as LPNs, medical assistants, or estheticians. (Tr. at 23-28)

13. Kelly Wert, CT, expressed support for most of the changes in proposed rule 4731-18-03, but also expressed agreement with the comments and recommendations from Amanda Nelson, CT, President of the Cosmetic Therapy Association of Ohio (discussed below). Particularly, Ms. Summary of May 17, 2021 Public Rules Hearing Page 7 Case No. 21-PRH-0002

Wert noted that the requirements for supervision created barriers. In addition, the limitation of delegating to only two persons at a time inhibits the growth of her practice and would result in Ms. Wert having to hire an additional physician or NP which is cost prohibitive. Ms. Wert also noted that Dr. Bechtel had previously stated that appropriately trained CTs should be included in vascular and photodynamic therapy and that this limitation affects a CTs ability to be hired by physicians. (Ex. 6 at 43-48)

14. Manu Aggarwal commented that often CTs have more training in laser hair and electrolysis treatments and are more qualified than CNPs, PAs, or RNs. She further noted that utilizing both laser hair reduction and electrolysis is often more successful than utilizing only one form of treatment. She further stated:

To strip away the ability of someone who has trained and provided these services is literally taking away their livelihood. I cannot imagine if the same was done to any other profession. This stripping of the earned stripes is such a disgrace for one's level of integrity. Put yourself in the other person’s shoes and try to understand their dilemma. If you know anything about medicine, this is it; compassion for the fellow provider and their patients.

(Ex. 6 at 49-50)

15. Martha Sweterlitsch, an attorney with Benesch Friedlander Coplan and Arnoff, LLP, submitted a written statement and provided testimony at hearing on behalf of the Ohio Society of Cosmetic Therapy. (Tr. at 13-20) Ms. Sweterlitsch expressed her gratitude for the Board’s work after the passage of H.B. 442. She identified four areas of concern regarding proposed rule 4731-18-03:

1. Probe Electrolysis using Electric Current on Face and Body is Left Unregulated

We recognize that the Medical Board has limited authority after the passage of HB 442, but from a patient protection perspective and for our client that care about the professionalism of their industry and the safety of their electrology patients, it is overly concerning that electrolysis is left completely unregulated. Whenever you are dealing with an electrical current being delivered within skin to terminate the growth of hair at the dermal papilla, there is a risk of potential burn. If the provider is untrained and inexperienced with no minimum standards of sanitation and hygiene there is a risk of infection, transmission of disease, break down of the skin and a high risk of burning the skin. It is irresponsible of Ohio to leave this profession without any regulations, and we would urge the Ohio Medical Board to look at any options that potentially could be available to patients through rule.

2. The required physician involvement in the proposed training is prohibitive in terms of cost and identifying willing physicians. Summary of May 17, 2021 Public Rules Hearing Page 8 Case No. 21-PRH-0002

The required physician involvement in the proposed training for therapists using light based medical devices (lasers in the vernacular) is prohibitive both in terms of cost and identifying willing physicians. As this Board recognizes in proposed rule 4731-18-02, the application of light-based medical devices to the human body is the practice of medicine, albeit in the case of hair removal by a trained therapist, an area of limited practice, but medicine none the less. For the uninitiated, we are NOT talking about the plucking of a few eyebrow or chin hairs for improving appearance. Permanent hair removal is desirable and often necessary to a patient’s health and well being for a variety of reasons of which this Board is aware.

The training for cosmetic therapists prior to the passage of HB 442 was approved by the State Board of Career Colleges and Schools and has adequately trained practitioners for years to allow physicians to safely delegate use of a light-based medical device for hair removal. Proposed rule 4731-18-3(7) contemplates a complicated and expensive training process that requires the active involvement of a practicing physician for each student including the student observing a physician performing 20 procedures for each type of procedure for hair removal delegated and the physician personally observing 15 procedures by each student for each type of laser for hair removal delegated. Given that there are multiple types of procedures, the amount of time to be spent by the physician will dramatically increase the cost of training, and that assumes that physicians will be able and willing to devote the time required. It will be much simpler for the physician to simply delegate to a physician assistant, who will not be required to undergo any specific training. Under the rule only cosmetic therapists, RNs and LPNs are subject to these specific training requirements. In short, the proposed training regimen practically guarantees that no one will be able to enter the profession.

We would respectfully request that the Board allow the training to be approved by the State Board of Career Colleges and Schools as is currently the process and allow physicians to safely delegate without the expensive and complicated addition of these provisions. The therapist could simply show the physician proof of successful completion of the required curriculum and national testing that is already available. Proof of continuing education could similarly be provided to the delegating physician. This Board could cooperate with the Board of Career Colleges and Schools to assure that the curriculum continues to serve the medical profession.

3. Current CT Students are left in limbo as are inactive, but licensed CTs

licensed CTs who have not been actively working with laser during the immediately preceding two years. We respectfully request the Board modify this provision to accommodate these two categories of current and future Cosmetic Therapists.

4. Off-Site Supervision Should not be limited to 60 minutes travel time

Cosmetic Therapists cannot do their job if their delegating physician travels and, therefore, patients do not get served. We respectfully request the removal of the 60-mile limitation. The pandemic has fostered the rise of innovative medical services like telehealth and physicians can adequately assess a patient through electronic means should it be necessary to contact them.

We respectfully request that the Board modify the supervision requirements and permit the physician to be available through electronic means or telehealth if available.

(Ex. 6 at 53-55)

16. Vickie Mickey, CT, CLT, of About Face Cosmetic Therapy Training Center, also thanked the Board for its quick work after the passage of H.B. 442. She explained that one of her employees did not have a letter from a delegating physician, and it was arranged for that employee to observe 20 procedures with a physician and to perform 30 procedures with the physician. However, this caused resentment in the employee and imposed a financial burden on the business. Ms. Mickey requested that the Board revise the training requirements for CTs back to 20 hours of didactic training and 30 hours of clinical hair removal. She also pointed out that the proposed rule will require cosmetic therapy training programs to employ a physician for supervision. Finally, she asked why the physician observation would be required if the CT had passed a national examination for laser hair removal and pointed out that the scope of practice for nurses, PAs and NPs does not include hours of permanent hair removal training. (Ex. 6 at 56-59)

Ms. Mickey also submitted a second comment on behalf of Cosmetic Therapy Training Center. She wrote that proposed rule 4731-18-03 would require training programs to hire a physician to train CTs and triple the cost of laser hair removal training. She questioned why the previous training standards were not utilized in the new rule. Ms. Mickey also noted that very few physicians actually perform laser hair removal due to the cost. Ms. Mickey wrote that H.B. 442 was enacted to allow people to practice permanent hair removal without any rules or regulations and that patients are going to be treated by under trained electrologists. (Ex. 6 at 60-63)

17. Marley Miller was a student at the Cosmetic Therapy Training Center when H.B. 442 was passed, and she had already completed the 20 hours of didactic training as well as the 30 hours of clinical laser hair removal training. She further stated that no other state requires the amount Summary of May 17, 2021 Public Rules Hearing Page 10 Case No. 21-PRH-0002

of observed and performed procedures for laser hair removal that Ohio is proposing. Ms. Miller expressed concern that she has invested $17,000 to complete a program when H.B. 442 set no standards of care for cosmetic therapy nor any required training, rules, or regulations. Finally, she wrote that many patients need well trained electrologists to perform both electrology and laser hair removal due to PCOS and gender reassignment. (Ex. 6 at 64-66)

18. Amanda Nelson, CT, President of the Cosmetic Therapy Association of Ohio, submitted a written comment and appeared at the hearing. (Tr. at 29-34) At hearing, Ms. Nelson noted that it can be difficult to find a supervising physician as many hospital systems do not allow their physicians to have business relationships with outside entities. (Tr. at 30-31) She also provided a summary of her comments and proposed actions:

(Ex. 6 at 67-71)

19. Mathew Avram, M.D., J.D., President the American Society for Dermatologic Surgery Association, wrote to express his support for proposed rule on the use of light based medical devices. He wrote: Summary of May 17, 2021 Public Rules Hearing Page 11 Case No. 21-PRH-0002

These commonsense regulations ensure that any light based medical procedures are delegated to the correct individuals and that a physician is on- site at all times to supervise non-physician providers.

With multiple medical laser devices available on the market, and as more devices become available, it is critical to ensure that patient safety remains the primary objective. Quality patient care includes evaluating a patient’s needs and current condition, selecting an appropriate course of treatment, and providing adequate information and follow-up care. Any procedure which utilizes energy-based devices capable of damaging living tissue performed on human beings for cutaneous conditions should be considered as the practice of medicine. Procedures performed with lasers is consistent with the American Medical Association and the American College of Surgeon’s definition of surgery.

(Ex. 6 at 74)

20. Dana Domer, MPAS, PA-C, Assistant Professor and Clinical Coordinator for the University of Mount Union PA Studies Program, wrote to express support for PAs to be allowed to use laser and light based devices. She commented that PAs are procedure oriented whereas NPs are not procedure oriented. However, NPs are allowed to use such devices. She also wrote:

I completely believe that Physician Assistants are competently trained and are completely qualified to be able to use these devices with the initial OK from their collaborating physician. If you are able to look into the training of the PAs, you will see that it is 15 months of medical study, then 10 months of clinical training. Through all this training the PA student must prove their competencies in performing procedures.

(Ex. 8)

21. Shannon Urena, MS, MS, PA-C, wrote, in regard to proposed rule 4731-18-02:

PAs are board certified in medical education and undergo many rigorous hours of training. I would argue that PAs have almost the same amount of hours in training as a physician, without residency training. For example, MDs and DOs accumulate approximately 182 credit hours in didactic, where PAs accumulate approximately 128 credit hours in didactic. In regards to clinical hours, MDs and DO accrue approximately 3000+ where PAs accrue approximately 2,000+.

PAs are highly qualified and have exceptional training. It is disappointing our current laws have not been updated to compliment the new PA laws. Allowing Summary of May 17, 2021 Public Rules Hearing Page 12 Case No. 21-PRH-0002

PAs to use light based medical devices would greatly improve patient access to those treatments.

Ms. Urena also commented that the proposed rule would take away a PAs ability to timely treat patients. (Ex. 9)

22. Angelina Dreimiller, PA-C, wrote:

I'm reaching out to you due to concerns about the fact that PAs are qualified to utilize a Co2 laser, in all 48 states except for MD and OH! This affects patient access to care especially in specialties such as dermatology and plastic surgery. This also limits the number of job opportunities allowed for PAs in these specialties.

Not sure why we limited in the use of CO2 lasers, but hoping this will change in legislation.

(Ex. 10)

23. Serina Abdul Satter is a pre-PA student, and she wrote:

Hope you are doing well. My name is Serina Abdul Satter and I am a Pre PA student. I am writing to you today in hopes of having Ohio PAs join the thousands of PAs using CO2 laser. Not only are PAs qualified to use this technique, other states have shown that PAs provide effective results to patient. Physician Assistants have improved wait times, quality of care, and access to care. By amending the laws surrounding by the profession, PAs can continue to improve the care for patients all over. As I further emerge myself in the field, making sure that PAs are not underestimated is extremely important. I thank you for taking the time for reading what I have to say. I hope that as a profession, we continue to grow and thrive.

(Ex. 11)

24. Jeanne Griebling, CT, submitted a written comment, but her comment appears to be primarily a response to an email from Ms. Ott-Statzer which was attached. Ms. Griebling does not feel that CT training should begin until after a person is at least 18 years old, has graduated high school or obtained a GED, and has passed a criminal background check. She further wrote that training should be done at a community or technical college, not a joint vocational school. Ms. Griebling further wrote that she has been told by the Cosmetology Board that she may practice anywhere she likes and that she is not required to obtain an independent contractor license. (Ex. 12)

Summary of May 17, 2021 Public Rules Hearing Page 13 Case No. 21-PRH-0002

CONCLUSION

The requirements of Chapter 119, Ohio Revised Code, have been satisfied. The Board may proceed to take action regarding the proposed recission of Rules 4731-18-02, 4731-18-03, 4731- 18-04, 4759-4-04, and 4759-4-08; the proposed adoption of new Rules 4731-18-01, 4731-08-02, 4731-18-03, 4731-18-04, 4759-4-04, and 4759-4-08; and the proposed amendment of Rules 4731-13-01, 4731-13-03, 4731-13-06, 4731-13-07, 4731-13-07.1, 4731-13-08, 4731-13-09, 4731-13-13, 4731-13-15, 4731-13-16, 4731-13-17, 4731-13-33, and 4731-13-36.

Kimberly A. Lee Hearing Examiner MASTER COPY OF PUBLIC RULES HEARING ON MAY 17, 2021 REGARDING PROPOSED CHANGES TO THE OHIO ADMINISTRATIVE CODE

A Master Copy would include sealed and proffered exhibits, if any. This original record contains no sealed or proffered exhibits.

• Report of Hearing

• Transcript

• Condensed Transcript • Full-Page Transcript • Word Index

• Exhibits

Exhibit 1: Copy of the rules originally filed in Package 189936 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule- Filing System on April 9, 2021, a copy of the confirmation of filing, and a copy of the confirmation of the revised filing on April 16, 2021.

Exhibit 2: Copy of the rules originally filed in Package 190003 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule- Filing System on April 12, 2021, a copy of the confirmation of filing, and copies of the confirmations of revised filings on April 16, 2021 and May 3, 2021.

Exhibit 3: Copy of the rule originally filed in Package 190004 with JCARR, Secretary of State, and the Legislative Services Commission via the Electronic Rule- Filing System on April 9, 2021, a copy of the confirmation of filing, and a copy of the confirmation of the revised filing on April 19, 2021.

Exhibit 5: Copies of the address portion of e-mails sent to persons and organizations pursuant to their standing request to be notified when the Medical Board proposes rules.

Summary of May 17, 2021 Public Rules Hearing Page 2 Case No. 21-PRH-0002

Exhibit 6: Copies of comments received from received from: Jason Lichten; Jessica Watkins, PA, MONA Dermatology; Jen Johns of The Academy of Medicine of Cleveland and Northern Ohio; Scott Cackler; Kelly Ott-Statzer; Stephen Lopez, M.D.; Kay Mavko, MS, RDN, LD, and Patricia McKnight, MS, RDN, LD, Ohio Academy of Nutrition and Dietetics; Kristine Good-Bath; Anna Luning, CNP, MONA Dermatology; Mona Foad, M.D., MONA Dermatology; Kelly Wert, Cosmetic Therapy Association of Ohio; Manu Aggarwal; Martha Sweterlitsch, Ohio Society of Cosmetic Therapy Training; Vickie Mickey, About Face Cosmetic Therapy Training Center; Vickie Mickey, Cosmetic Therapy Training Center; Marley Miller; Amanda Nelson, Cosmetic Therapy Association of Ohio; and Emily Besser, MA, CAE, and Mathew Avram, M.D., J.D., American Society for Dermatologic Surgery Association.

Exhibit 7: Comment from Kelly Ott-Statzer

Exhibit 8: Comment from Dana Domer, MPAS, PA-C

Exhibit 9: Comment from Shannon Urena, M.S., M.S., PA-C

Exhibit 10: Comment from Angelina Dreimiller, PA-C

Exhibit 11: Comment from Serina Abdul Satter

Exhibit 12: Comment from Jeanne Griebling, CT

STATE MEDICAL BOARD OF OHIO

RECEIVED: May 26, 2021

SUMMARY OF THE MAY 17, 2021 PUBLIC HEARING REGARDING PROPOSED CHANGES TO THE OHIO ADMINISTRATIVE CODE

PURPOSE OF THE HEARING

The following changes are proposed:

Light Based Medical Devices Rules

Rule No. Title Proposed Action

Hearing Rules

Rule No. Title Proposed Action

Dietetics Rules

PROCEDURAL MATTERS

2. Due to the ongoing Covic-19 emergency, the hearing was conducted via videoconferencing software.

TESTIMONY HEARD

EXHIBITS EXAMINED

12, 2021, a copy of the confirmation of filing, and copies of the confirmations of revised filings on April 16, 2021 and May 3, 2021.

Exhibit 5: Copies of the address portion of e-mails sent to persons and organizations pursuant to their standing request to be notified when the Medical Board proposes rules.

Exhibit 7: Comment from Kelly Ott-Statzer

Exhibit 8: Comment from Dana Domer, MPAS, PA-C

Exhibit 9: Comment from Shannon Urena, M.S., M.S., PA-C

Exhibit 10: Comment from Angelina Dreimiller, PA-C

Exhibit 11: Comment from Serina Abdul Satter

Exhibit 12: Comment from Jeanne Griebling, CT

SUMMARY OF EVIDENCE

interested parties regarding the proposed rule changes, and with respect to other procedural matters. (Hearing Transcript (“Tr.”) at 8-11)

2. There were no comments on the Board’s proposed hearing rules.

7. Scott Cackler commented:

(Ex. 6 at 17-18) Summary of May 17, 2021 Public Rules Hearing Page 5 Case No. 21-PRH-0002

8. Kelly Ott-Statzer, an unlicensed CT, posed a number of questions and concerns in her her original comment. In summary, she wrote:

How long does the requirement for on-site supervision in proposed rule 4731-18-03(B)(8) remain in effect? How does this work with the off- site supervision provision in proposed rule 4731-18-03(C)?

Can telemedicine be utilized in regard to this rule? Given the pandemic, telemedicine limits exposure and allows for off-site communication.

The distance restriction will require CTs to cancel all of their appointments if the delegating physician goes out of town and thereby deprives the CTs of income.

(Ex. 6 at 20-23)

(Ex. 7) Summary of May 17, 2021 Public Rules Hearing Page 6 Case No. 21-PRH-0002

(Ex. 6 at 49-50)

1. Probe Electrolysis using Electric Current on Face and Body is Left Unregulated

3. Current CT Students are left in limbo as are inactive, but licensed CTs

4. Off-Site Supervision Should not be limited to 60 minutes travel time

We respectfully request that the Board modify the supervision requirements and permit the physician to be available through electronic means or telehealth if available.

(Ex. 6 at 53-55)

(Ex. 6 at 67-71)

(Ex. 6 at 74)

(Ex. 8)

21. Shannon Urena, MS, MS, PA-C, wrote, in regard to proposed rule 4731-18-02:

PAs to use light based medical devices would greatly improve patient access to those treatments.

Ms. Urena also commented that the proposed rule would take away a PAs ability to timely treat patients. (Ex. 9)

22. Angelina Dreimiller, PA-C, wrote:

Not sure why we limited in the use of CO2 lasers, but hoping this will change in legislation.

(Ex. 10)

23. Serina Abdul Satter is a pre-PA student, and she wrote:

(Ex. 11)

Summary of May 17, 2021 Public Rules Hearing Page 13 Case No. 21-PRH-0002

CONCLUSION

Kimberly A. Lee Hearing Examiner

TRANSCRIPT

CONDENSED

TRANSCRIPT

Proceedings

Page 1 BEFORE THE OHIO MEDICAL BOARD - - - In the Matter of: ) MEDICAL RULES HEARING )

- - - PROCEEDINGS before Kimberly Lee, Hearing Examiner, at the Ohio Medical Board, 30 East Broad Street, Room 336, Columbus, Ohio 43215, called at 1:30 a.m. on Monday, May 17, 2021.

ARMSTRONG & OKEY, INC. 222 East Town Street, Second Floor Columbus, Ohio 43215-4620 (614)224-9481 - (800) 223-9481

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Page 2 Page 4 1 APPEARANCES 1 Monday, May 17, 2021 2 - - - 2 1:30 p.m. 3 Kimberly Anderson 3 - - - Chief Legal Officer for Medical 4 HEARING OFFICER: All right. Good 4 Board of Ohio 5 afternoon, everyone. Let's go on the record. This 30 East Broad Street 5 Columbus, Ohio 43215 6 is the public hearing for the State Medical Board 6 7 of Ohio. It is now in session. Let the record On behalf of the Ohio Medical Board 8 show that this public hearing is convened at 1:32 7 9 p.m. on Monday, May 17th, 2021, via GoTo Webinar. 8 - - - 10 This public hearing was called pursuant to Section 9 11 119.03 of the Ohio Revised Code. 10 12 I am Kimberly Lee, hearing examiner for 11 13 the State Medical Board of Ohio. I'm conducting 12 14 this public rules hearing on behalf of the Board. 13 14 15 The members of the Board will review the report 15 16 concerning this hearing including any written 16 17 materials submitted as evidence and they will also 17 18 have the transcript of today's hearing available 18 19 for review. 19 20 So today the following rules are 20 21 proposed. In regards to light-based medical 21 22 devices, we have 4731-18-01, definitions, is a 22 23 23 proposed new rule. 24 24 4731-18-02, use of light-based medical 25 25 devices is a proposed new rule and also 4731-18-02

Page 3 Page 5 1 INDEX 1 use of light-based medical devices is proposed to 2 KIMBERLY ANDERSON 2 be rescinded. Examination by Ms. Lee 08-07 3 4731-18-03, delegation of the use of 3 EXHIBITS 4 light-based medical devices for specified 4 5 non-ablative procedures is a proposed new rule. 5 State's Ident. Admit 6 And 4731-18-03, delegation of the use of 6 1 - Package 189936 08-21 11-16 7 light-based medical devices for specified 7 2 - Package 190003 08-21 11-16 8 non-ablative procedures is proposed to be 8 3 - Package 190004 08-21 11-16 9 rescinded. 9 4 - Notice of Hearing 08-21 11-16 10 4731-18-04, delegation of phototherapy 10 5 - Email List 08-21 11-16 11 and photodynamic therapy is a proposed new rule. 11 6 - Comments 08-21 11-16 12 4731-18-04, delegation of phototherapy and 12 13 photodynamic therapy is proposed to be rescinded. 13 14 In regard to hearing rules 4731-13-01, 14 15 15 representatives appearances is proposed to be 16 16 amended. 17 17 4731-13-03, authority and duties of 18 18 hearing examiners is proposed to be amended. 19 19 4731-13-06, continuance of hearing is 20 20 proposed to be amended. 21 21 4731-13-07, motions is proposed to be 22 22 amended. 23 23 4731-13-07.1, form and paid limitations 24 24 for briefs and memoranda is proposed to be amended. 25 25 4731-13-08, filing is proposed to be

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Page 6 Page 8 1 amended. 1 matter. Could you please swear in Miss Anderson. 2 4731-13-09, service is proposed to be 2 - - - 3 amended. 3 KIMBERLY ANDERSON, 4 4731-13-13, subpoenas for purposes of 4 being first duly sworn, as provided by law, was 5 hearing is proposed to be amended. 5 examined and testified as follows: 6 4731-13-15, reports and recommendations 6 EXAMINATION 7 is proposed to be amended. 7 BY MS. LEE: 8 4731-13-16, reinstatement or 8 Q. Thank you very much. Could you please 9 restoration of certificate is proposed to be 9 state your name and how you are employed? 10 amended. 10 A. Kimberly Anderson, Chief Legal Counsel, 11 4731-13-17, settlements, dismissals and 11 State Medical Board of Ohio. 12 voluntary surrenders is proposed to be amended. 12 Q. Are you familiar with the filings and 13 4731-13-33, Physicians' Desk Reference 13 other actions taken for purposes of the rules being 14 is proposed to be amended. 14 considered today? 15 And 4731-13-36, disciplinary actions is 15 A. Yes. 16 proposed to be amended. 16 Q. What part did you play in the filing of 17 In regards to dietetic's rules, 17 the rules? 18 4759-4-04, continuing education is a proposed new 18 A. I participated in their filing and the 19 rule. 4759-4-04, continuing education is proposed 19 distribution of the notice of public hearing. 20 to be rescinded. 20 - - - 21 4759-4-08, limited permit is a proposed 21 (Board's Exhibits 1 - 6, were marked for 22 new rule. 4759-4-08, limited permit is proposed to 22 purposes of identification.) 23 be rescinded. 23 - - - 24 And 4759-6-02, standards of 24 BY MS. LEE: 25 professional performance is proposed to be amended. 25 Q. Can you please identify the documents

Page 7 Page 9 1 The purpose of this hearing today is to 1 that have been marked as exhibits? 2 provide an opportunity for any purpose -- for any 2 A. Yes. Exhibit 1 is a copy of the rules 3 person, excuse me, affected by the proposed rules 3 originally filed in package 189936 with JCARR, 4 to be heard. 4 Secretary of State and the Legislative Services 5 Any affected person may present his or 5 Commission, via the Electronic Rule-Filing System 6 her positions, arguments or contentions orally or 6 on April 9th, 2021 and a copy of the confirmation 7 in writing and may present evidence tending to show 7 of filing. Also included is a copy of the 8 that the proposed adoption of the rules as proposed 8 confirmation of the revised filing on April 16th, 9 will be unreasonable or unlawful. 9 2021. 10 All persons who testify orally today 10 Exhibit 2, is a copy of the rules 11 are asked to raise their hands by clicking on the 11 originally filed in package 190003 with JCARR, 12 hand icon on their control panel. If you have a 12 Secretary of State and the Legislative Services 13 written copy of your testimony, submission of the 13 Commission via the Electronic Rule-Filing System on 14 written copy will assist the Board in its review of 14 April 12th, 2021, and a copy of the confirmation of 15 your comments. Written statements may also be 15 filing. Also included is a copy of the 16 submitted today without testifying. 16 confirmation of the revised filings on April 16th, 17 You can send electronic copies of your 17 2021 and on May 3rd, 2021. 18 comments to me and my email address is 18 Exhibit 3, is a copy of the rules 19 [email protected]. And I'll repeat that 19 originally filed in package 190004 with JCARR, 20 address later in this proceeding, so you don't need 20 Secretary of State and the Legislative Services 21 to scramble to write it down right now. 21 Commission via the Electronic Rule-Filing System on 22 But I want to now recognize Kim 22 April 9th, 2021, and a copy of the confirmation of 23 Anderson, Chief Legal Counsel for the Medical Board 23 filing. Also included is a copy of the 24 for the presentation of testimony on the Board's 24 confirmation of the revised filing on April 19th, 25 compliance with the legal requirements in this 25 2021.

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Page 10 Page 12 1 Q. Thank you. Was public notice of the 1 Moreover, the Board reserves the right 2 rules that are the subject of this hearing given to 2 to limit the testimony of any witness if the 3 the Registrar of Ohio at least 30 days prior to 3 testimony appears to be irrelevant or cumulative. 4 today? 4 If a witness has a written copy of his 5 A. Yes. Exhibit 4 is a copy of the notice 5 or her testimony or other documents that you wish 6 of public hearing that was filed on April 12th, 6 to have marked as exhibits, the documents should be 7 2021 for rules in packages 189936, 190003, and 7 emailed to me at the conclusion of your testimony. 8 190004. Also included is a copy of the notice of 8 If you have a written statement you 9 public hearing refiled on April 16th, 2021 for 9 wish to submit without giving testimony, you can 10 rules in packages 189936 and 190003 and on April 10 also email that to me so it can be marked as an 11 19th, 2021 for rule package 190004. 11 exhibit. And once again, here is my email address. 12 Q. Was notice of the proposed rules 12 It is [email protected] that is 13 provided to any persons or organizations? 13 [email protected]. 14 A. Yes. Exhibit 5 contains copies of the 14 All right. So if anybody wishes to 15 address portion of emails sent to persons and 15 testify, please, you know, raise your hand on your 16 organizations pursuant to their standing request to 16 control panel and we will go from there. 17 be notified when the Medical Board proposes rules. 17 I only see one hand raised and that is 18 Q. Were any requests for copies of the 18 Marty Sweterlitsch. You are on mute, would you 19 proposed rules received in the Board office? 19 like -- 20 A. No. 20 MS. SWETERLITSCH: I'm here. 21 Q. Were any written comments on the 21 HEARING OFFICER: Can you hear me? 22 proposed rules received in the Board's office? 22 MS. SWETERLITSCH: I can hear you. 23 A. Yes. Exhibit 6 is a copy of the 23 HEARING OFFICER: All right. Thank you 24 comments received from Jason Lichten; Jessica 24 very much. Can you please state your name and 25 Watkins, PA of MONA Dermatology; Jen Johns of the 25 address for the record?

Page 11 Page 13 1 Academy of Medicine of Cleveland and Northern Ohio; 1 MS. SWETERLITSCH: Absolutely. My full 2 Scott Cackler; Kelly Ott-Statzer -- Statzer; 2 name is Martha J. Sweterlitsch. I'm a partner at 3 Stephen Lopez, M.D.; Kay Mavko, of the Ohio Academy 3 Benesch, Friedlander, Coplan and Aronoff. The 4 of Nutrition and Dietetics; Kristine Good-Bath; 4 address is 41 South High Street, Suite 2600, 5 Anna Luning, CNP of MONA Dermatology; Mona Foad, of 5 Columbus, Ohio 43215. 6 MONA Dermatology; Kelly Wert, Cosmetic Therapy 6 HEARING OFFICER: Thank you. Are you 7 Association of Ohio; Manu Aggarwal; Marty 7 appearing on behalf of any organization today? 8 Sweterlitsch, of the Ohio Society of Cosmetic 8 MS. SWETERLITSCH: I am appearing on 9 Therapy Training, Vickie Mickey, AboutFace Cosmetic 9 behalf of the Ohio Society of Cosmetic Therapy 10 Therapy Training Center; Vickie Mickey, Cosmetic 10 Training. And we are commenting on -- basically on 11 Therapy Training Center; Marley Miller; Amanda 11 rule 4731-18-03. Apologize for looking down, but I 12 Nelson of the Cosmetic Therapy Association of Ohio 12 have to read my testimony and I didn't make the 13 and Emily Besser of the American Society for 13 print big enough and that is my fault. 14 Dermatologic Surgery Association. 14 HEARING OFFICER: You are totally fine. 15 HEARING OFFICER: Thank you very much. 15 If it makes you feel any better, the way this 16 Exhibits 1 through 6 are admitted into the record. 16 program works is that for the commentators the 17 Thank you, Miss Anderson. 17 camera is not active, so.... 18 THE WITNESS: Thank you. 18 MS. SWETERLITSCH: Okay. So I'm ready 19 HEARING OFFICER: All right. Now, it 19 to begin if you are. 20 is time to receive testimony on the proposed rules 20 HEARING OFFICER: Yes, ma'am, please 21 from interested party. Please remember that the 21 proceed. 22 purpose of this hearing is to receive ideas, 22 MS. SWETERLITSCH: Okay. And the first 23 comments and concerns regarding the proposed rules. 23 thing we want to do is express our gratitude for 24 It is not the appropriate time to seek debate on 24 all of the work that the Board and the staff have 25 those proposed rules. 25 done and put into these efforts after the passage

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Page 14 Page 16 1 of House Bill 442 by the 133rd General Assembly, 1 the proposed training for therapists under 2 which effectively removed the regulatory structure 2 light-based medical devices, lasers in the 3 for cosmetic therapists over a limited practice of 3 vernacular for those who are listening, is 4 medicine. 4 prohibitive both in terms of cost and identifying 5 We understand that the Medical Board 5 willing physicians. 6 had no knowledge of the change prior to the passage 6 As this Board recognizes in proposed 7 of the law and that nearly 200 mostly women-owned 7 Rule 4731-18-02, the application of light-based 8 businesses that operate in Ohio can continue 8 medical devices to the human body is the practice 9 working because of your quick action and dedicated 9 of medicine, albeit in the case of hair removal by 10 efforts to help with the emergency rule and we just 10 a trained therapist, an area of limited practice 11 really do appreciate all the conversations that we 11 but medicine nonetheless. 12 have been able to have about that. 12 For the uninitiated, we are not talking 13 We have identified four areas of the 13 about the plucking of a few eyebrows or chin hairs 14 rule in which our clients believe provide obstacles 14 for improving appearance. Permanent hair removal 15 for the profession of cosmetic therapy today and 15 is desirable and often necessary to a patient's 16 going forward. 16 health and well-being for a variety of reasons, of 17 We respectfully ask the Board to 17 which I'm sure this Board is aware given your long 18 consider modifying the rules to address these 18 experience with this area. 19 issues as they move through the JCARR process. 19 The training for cosmetic therapists 20 The first area is the probe 20 prior to the passage of House Bill 442 was approved 21 electrolysis using electric current on face and 21 by the State Board of Career Colleges and Schools 22 body is left unregulated. We recognize that the 22 and has adequately trained practitioners for years 23 Medical Board has limited authority after the 23 to allow physicians to safely delegate the use of 24 passage of 442. 24 light-based medical devices for hair removal under 25 But from a patient protection 25 the rules that you have in place.

Page 15 Page 17 1 perspective and for our clients that care about the 1 The proposed rule contemplates a 2 professionalism of their industry and the safety of 2 complicated and excessive training process that 3 their electrology patients, it is very concerning 3 requires the active involvement of a practicing 4 that electrolysis is left completely unregulated. 4 physician for each student, including the student 5 Whenever you are dealing with an 5 observing a physician performing 20 procedures of 6 electrical current being delivered within skin to 6 each type of procedure for hair removal that is 7 terminate the growth of hair at the dermal papilla, 7 delegated and the physician personally observing 15 8 there is a risk of potential burn. 8 procedures by each student for each type of laser 9 If the provider is untrained and 9 or hair removal that is being delegated. 10 inexperienced with no minimum standards of 10 Given that there are multiple types of 11 sanitation and hygiene, there is a risk of 11 procedures, the amount of time to be spent by the 12 infection, transmission of disease, break down of 12 physician will dramatically increase the cost of 13 the skin and a high risk of burning the skin. It 13 the training and that assumes that there will be 14 is simply irresponsible in Ohio to leave this 14 physicians able and willing to devote the time 15 profession without any regulation. And we would 15 required. 16 urge the Medical Board to look at any options that 16 It will be much simpler for the 17 you might have to potentially protect patients 17 physician to simply delegate to a physician 18 under this admittedly very limited practice of 18 assistant who will not be required to undergo any 19 medicine. 19 special training under your rules or under their 20 Our second concern is the required 20 standards of practice. 21 physician involvement in the proposed training for 21 Under the rule, only cosmetic 22 light-based technology is prohibitive in the 22 therapists, R.N.'s and L.P.N.'s are subject to 23 cost -- in terms of its costs and identifying 23 these specific training requirements. In short, 24 willing physicians. 24 the proposed training regimen practically 25 The required physician involvement in 25 guarantees that no one will be able to enter the

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Page 18 Page 20 1 profession. 1 going to be chained to their offices and the 2 We would respectfully request that the 2 patients need help when the patients need help. 3 Board allow the training to be approved by the 3 We respectfully request the removal of 4 State Board of Career Colleges and Schools as is 4 the 60-mile limitation. The pandemic has fostered 5 currently the process and allow physicians to 5 the rise of innovative medical services like 6 safely delegate without the expensive and 6 telehealth and physicians can adequately assess a 7 complicated addition of these provisions. 7 patient through electronic means should it be 8 The therapists would simply show the 8 necessary to contact them. 9 physician proof of successful completion of the 9 And certainly if there is an incident 10 required curriculum and national testing, which is 10 that requires immediate medical attention, we have 11 already available from several associations. Proof 11 to send people to Urgent Care or the Emergency Room 12 of continuing education can similarly be provided 12 any way. A physician who is 59 miles away is not 13 to the delegating physician. 13 going to be able to deal with that. 14 This Board could cooperate with the 14 So those are our -- those are our 15 Board of Career Colleges and Schools to assure that 15 comments on the rule. Again, I want to thank you 16 the curriculum continues to serve the medical 16 for the opportunity to offer this testimony on 17 profession because we understand that curriculum 17 behalf of our client and to work with the Board on 18 has to be relevant and you have to be comfortable 18 hopefully coming up with something that will at 19 with it. 19 least make the situation better for the therapists. 20 Our third area of concern is that there 20 I'm happy to answer any questions that 21 are cosmetic therapy students who are left in limbo 21 you might have with the caveat that I am not a 22 because they are in training and they don't have a 22 technician of cosmetic therapy. 23 current license, so they are not grandfathered and 23 HEARING OFFICER: Thank you very much. 24 there is no provision in the rule for them other 24 I do not have any questions for you, but I do 25 than sort of starting over under this new regimen, 25 appreciate your comments and we also have your

Page 19 Page 21 1 which may or may not exist. 1 written letter as an exhibit as well. 2 Specifically, it delegates that who 2 MS. SWETERLITSCH: Thank you very much. 3 have been applying light-based therapy must be 3 HEARING OFFICER: Thank you. If 4 active for two years prior to the effective date of 4 anybody else would like to testify today, if you 5 this rule. Current students are in limbo as well 5 could please raise your hand. 6 as licensed CPs, who have not been actively working 6 I see Natasha Fogle has raised her 7 with the laser during the immediately preceding two 7 hand. Miss Fogle, it looks like you are joining by 8 years. 8 phone and it says you can't be unmuted until you 9 We respectfully request the Board to 9 enter a pin. I have told the system to send you 10 modify this provision to accommodate these two 10 the pin, so hopefully we can get that resolved and 11 categories of current and future cosmetic 11 you can speak here in a moment. Give a minute to 12 therapists. I understand you might want some 12 try to get that worked out. 13 additional continuing education for folks who 13 Does not appear that Miss Fogle is 14 haven't been active for a time, that is not an 14 putting in the pin. Give another minute here. And 15 unreasonable request to make, but having them start 15 anybody else, if you would like to give comments 16 all over again just doesn't seem necessary for 16 today, if you could also please raise your hand. 17 either category. 17 I see Miss Fogle has actually sent in a 18 Finally in number 4, the off-site 18 question, says they are having trouble and cannot 19 supervision should not be limited to 60-minute 19 find the pin. Hold on one moment. Miss Fogle, the 20 travel time in terms of the restriction on the 20 pin for you is 53539. I'm sorry, it is pound 53539 21 physician. 21 pound. 22 Cosmetic therapists cannot do their job 22 I don't see any other hands raised 23 if they are delegating physician travels and 23 other than Miss Fogle, so she is trying to get that 24 therefore, their patients don't get served and 24 resolved. We will give another minute here, so she 25 that's a problem. Because the physicians are not 25 can give her comments, if possible.

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Page 22 Page 24 1 We also have Amanda Nelson who would 1 In our letter, we included a couple of 2 like to speak. Let's go -- Miss Nelson, I'm going 2 scenarios in which it actually takes away from 3 to unmute you. It looks like you are self-muted. 3 their ability to take care of patients. Can you 4 If you would like to unmute. Miss Nelson, you need 4 hear me? Can you still hear me? 5 an audio pin since you are joining by phone. I'll 5 HEARING OFFICER: Yes, ma'am. 6 have it sent to. I'll read it to you as well. It 6 DR. FOAD: Okay. Wonderful. So, for 7 is pound 62693 pound. 7 example, in dermatology and this is not in 8 All right. Looks like Dr. Foad is also 8 cosmetics, it is just simply in dermatology, 9 trying to speak. 9 medical dermatology. You will have a patient to 10 DR. FOAD: Hello. Hello. 10 treat warts, for example. And one of the 11 HEARING OFFICER: Hi, Dr. Foad, is that 11 treatments that we use every day to treat warts is 12 you? 12 a pulse dye laser called VBeam laser. 13 DR. FOAD: Yes, can you hear me okay? 13 And so what ends up happening is 14 HEARING OFFICER: Yes. 14 repeatedly our physician assistants then cannot 15 DR. FOAD: I'm so sorry this is 15 treat those patients with a VBeam and they will end 16 difficult. 16 of using cryotherapy or, for example, doing, you 17 HEARING OFFICER: There is always a 17 know, salasylic acid. But there are times where 18 problem. Probably need to turn off a speaker 18 you really are going to better serve the patient in 19 somewhere. Now, I'm sure that audio is going on 19 using a laser to treat that wart. 20 and off, so I believe she is trying to resolve the 20 So what ends up happening is that then 21 issue. 21 physician assistant ends up having to reschedule 22 DR. FOAD: So yes, hello. 22 the patient on to either my schedule or a nurse 23 HEARING OFFICER: Hi, Doctor. 23 practitioner's schedule and then the patient has to 24 DR. FOAD: Can you hear me? 24 leave. They have to come back and frankly, I just 25 HEARING OFFICER: Yes, we can hear you. 25 don't think it is in the patient's best care and it

Page 23 Page 25 1 DR. FOAD: Okay. Great. Sorry about 1 also takes away their confidence in their physician 2 that. Actually Natasha Fogle was trying to get me 2 assistant. 3 on because I'm trying to come in from patients. So 3 Another example in dermatology and 4 I apologize for the confusion. 4 where we end up using light-based treatment often 5 HEARING OFFICER: You are fine. If I 5 is in rosacea. So you will have a patient come in. 6 could real briefly, just before you get going, if 6 They will have rosacea. You can go through, you 7 you could state your name and address for the 7 know, different prescriptions and skin care options 8 record and what organization you are with? 8 and invariably a lot of them want to have something 9 DR. FOAD: Absolutely. It is Dr. Mona 9 that treats it faster. 10 Foad, F as in Frank O-a-d as in David. I'm with it 10 And so we can either do again, a VBeam 11 is Cincinnati Dermatology Center doing business as 11 or something called intense pulse light, which is 12 MONA Dermatology and our address is 7730 Montgomery 12 another light-based therapy and again, that patient 13 Road, Cincinnati, Ohio 45236. 13 has to be sent to either an M.D. or an NP in order 14 HEARING OFFICER: All right. Thank 14 to treat them. 15 you. Please go ahead, Doctor. 15 So I feel like those are two examples 16 DR. FOAD: Okay. Wonderful. Well, I 16 where it really would help patient care for 17 have employed physician assistants and nurse 17 physician assistants to be able to use these lasers 18 practitioners for the last 19 years. And I 18 and lights and it also, as I said, helps the 19 actually train them in dermatology. 19 confidence in the patient. Because you could be 20 And I know that Jessica Watkins has 20 treating them for all of their medical concerns and 21 sent in a letter and I have sent in a letter kind 21 if you aren't able to further your treatment 22 of discussing why we feel that especially in the 22 because you don't have the ability to, I feel like 23 field of dermatology, it is very useful for 23 it takes away from the confidence that the patient 24 physician assistants to be able to treat their 24 would have in their provider. 25 patients with light-based therapies. 25 In addition, I feel that -- I

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Page 26 Page 28 1 understand that physician assistants and NP's have 1 limitation for physician assistants when there 2 a different background in how they get to be 2 isn't one for nurse practitioners. 3 providers of patient care, but I don't feel that -- 3 So that's it. I really appreciate your 4 I guess, I don't really understand why there is a 4 time and I'm so sorry that it was so difficult to 5 limitation on physician assistants when nurse 5 get us on. 6 practitioners have the same ability to be able to 6 HEARING OFFICER: I appreciate your 7 treat their patients with light-based devices and 7 comments, Dr. Foad, and my apologies that you 8 lasers. Was I too long winded? 8 experienced difficulties. 9 HEARING OFFICER: No, you were fine. I 9 DR. FOAD: Yeah, thank you so much. 10 wanted -- I didn't want to speak up if you had any 10 HEARING OFFICER: Have a good day. 11 further comments, Dr. Foad. 11 DR. FOAD: I hope you have a good rest 12 DR. FOAD: Yeah. Now, I do think that 12 of your meeting. All right. Bye-bye. 13 there is a difference, frankly, between a physician 13 HEARING OFFICER: Bye. All right. Is 14 assistant, for example, or an L.P.N. or a medical 14 there anybody else that would like to give comments 15 assistant or an esthetician, right. They 15 today, if you could raise your hand. 16 definitely have more training. And I feel like, 16 All right. Looks like Amanda Nelson 17 you know, when looking at the rule, I feel like 17 would like to speak. Miss Nelson, if you could 18 they should be in a category that is their own and 18 unmute yourself. 19 they should not be lumped in, for example, with 19 MS. NELSON: Hi. Thank you very much. 20 L.P.N.'s or medical assistants or estheticians. 20 Can you hear me? 21 And, frankly, I know that the ruling 21 HEARING OFFICER: Yes, we can hear you. 22 changed for injectables several years ago. So to 22 If you could just please state your name and the 23 be able to use an injectable like Botox or filler 23 address for the record and if you are representing 24 or Kybella or any of the injectables that are on 24 an organization, please state that as well. 25 the market, they are able to use those things. 25 MS. NELSON: Yes, I am Amanda Nelson

Page 27 Page 29 1 Well, as long as they have training for 1 and I am president of the Cosmetic Therapy 2 laser and light-based devices, I feel like they 2 Association of Ohio. Our address is Cosmetic -- 3 should be able to do the same thing. 3 HEARING OFFICER: Wait, wait, one 4 HEARING OFFICER: Are those all your 4 second. 5 comments, Dr. Foad? 5 MS. NELSON: I'm sorry. 6 DR. FOAD: I believe so. 6 HEARING OFFICER: My apologies, we lost 7 HEARING OFFICER: Okay. Just wanted to 7 you for just one moment there. 8 make sure. 8 MS. NELSON: Okay. My name is Amanda 9 DR. FOAD: I hope that helps. 9 Nelson. I'm the president of the Cosmetic Therapy 10 HEARING OFFICER: It is very helpful. 10 Association of Ohio. And we are a non-profit 11 Thank you. I know it is hard when we do these over 11 organization supporting the profession of cosmetic 12 the Internet, but I don't want to step on you if 12 therapy. Our contact information is 13 you have anything further to say. 13 [email protected]. And we submitted a 14 DR. FOAD: No, no. Like I said, I 14 letter over the weekend regarding our comments on 15 think that the number one reason is it is in the 15 this rule as well. 16 patient's best interest, that is always the most 16 So I do appreciate you allowing an 17 important thing. 17 opportunity for us to speak and I apologize if I 18 I think number 2, it takes away from 18 continue to have any additional technical 19 the confidence of the patient to their provider 19 difficulties because I was having some trouble as 20 because they can't do certain things. 20 well. 21 I think number 3, the training with 21 HEARING OFFICER: No worries. 22 physician assistants and nurse practitioners, 22 MS. NELSON: So I do want to echo one 23 although they reach the same end goal, they 23 sentiment that I had heard earlier about the 24 effectively are able to treat patients in the same 24 physician off-site supervision being limited to 25 way and so I feel like there should not be that 25 60-mile radius is rather burdensome.

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Page 30 Page 32 1 It is very common that our clients are 1 removing this part of the rule, is really to just 2 traveling over an hour to get our services. There 2 allow this small businesses to, you know, hire 3 is only 185 cosmetic therapists in the state and 3 within our own field. For cosmetic therapists who 4 especially in rural areas, there is -- it is 4 are coming into this field, they are going to have 5 certainly not uncommon for our clients to drive two 5 an opportunity to be in a licensed profession, that 6 to three hours for our services. 6 they are considered competent because these 7 So having a physician be required to be 7 grandfathered cosmetic therapists, if you will, 8 closer than they are, certainly provided some 8 will support the younger profession and we will 9 conflicts in the past. One thing that I think 9 hire within our own. And any one of our businesses 10 could help remedy the situation is we can utilize 10 really only support up to half a dozen cosmetic 11 some teleconference or telemedicine when it comes 11 therapists on the staff across, you know, two or 12 to this aspect a little bit because cosmetic 12 three locations. 13 therapy does go through the most rigorous amount of 13 And then the only other thing that I 14 training than any of the other delegated 14 really want to drive home is that in December of 15 professions. 15 2020 before House Bill came up that unlicensed our 16 I'm satisfied with the training 16 profession, Dr. Bechtel was very competent in our 17 outlined as they are proposed. It is my 17 ability to do delegated vascular laser treatments 18 interpretation that the observation treatments and 18 which are typically like -- 19 simply advised treatments actually occur with the 19 HEARING OFFICER: Miss Nelson. 20 doctor who is your long-term relationship, that you 20 MS. NELSON: Series of laser -- 21 have a business relationship with. That is the 21 HEARING OFFICER: Miss Nelson. 22 doctor who is actually going to be delegating to 22 MS. NELSON: Yeah. 23 you as a business. So it is not something that 23 HEARING OFFICER: I'm sorry to 24 would happen during the school. 24 interrupt you. Your sentences broke up. 25 However, one issue that we come across 25 MS. NELSON: I broke up. Yeah, I'm

Page 31 Page 33 1 is that doctors who are contracted with hospital 1 sorry, let me move to another location. 2 systems are not capable to have business 2 So yes, I was just saying that, you 3 relationships outside of those hospital systems. 3 know, Dr. Bechtel supported the cosmetic therapy 4 So finding an independent doctor can be 4 profession, the vascular treatments prior to my 5 very difficult. And the thing that ties into that 5 license, but having House Bill 2 that was supposed 6 is physicians supervising two cosmetic therapists 6 to be removed from the list and so considering that 7 at a time. 7 he is a president and that he is a dermatologist 8 So again, with the light-based therapy 8 and that he would know better than almost any other 9 being a small field, the requirement of having to 9 physician in the state about the safety of vascular 10 be supervised by one doctor would help us 10 laser treatments, we would strongly recommend that 11 immensely. Because there are about a dozen 11 we be included in that as well. 12 cosmetic therapy based businesses that do thrive. 12 And I think from the future forward 13 They get more facilities or they have more 13 because again, our businesses are so small. So the 14 certifications or multiple counties and oftentimes, 14 amount of services that we can incorporate into our 15 we still only have that one or maybe two, three, if 15 practices is such that it would be an economic 16 we are lucky, three is the maximum amount of 16 fallout of a post-Covid society, you know, any 17 doctors that our small businesses would ever be 17 little bit would help. We already have that 18 able to establish relationships with and move 18 established relationship with the doctor. 19 forward. 19 So basically the training requirements 20 So it is very unlikely that we would 20 are already in place with the eight hours of 21 ever be in a scenario where one doctor would be 21 education and then it would just require the 15, 22 supervising an appropriate amount of cosmetic 22 the 20 observations or supervised treatments for 23 therapists. To supervise up to dozen is very 23 some treatments or for vascular treatments in 24 unlikely. 24 addition to the 15 to 20 observation and supervised 25 So, you know, all I'm asking for by 25 treatment for laser hair removal.

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Page 34 1 So I do think that the amount of 2 doctors that would come to us if they knew that we 3 had a wider range of treatments that we could 4 provide them. 5 That covers most of what I wanted to 6 say. 7 HEARING OFFICER: Okay. Thank you very 8 much, Miss Nelson. I appreciate you taking the 9 time to give comments this afternoon. 10 MS. NELSON: Thank you so much. 11 HEARING OFFICER: All right. If 12 anybody else would like to give a comment, if you 13 could please raise your hand. Just looking at the 14 list. Give it another moment here. I'm not seeing 15 anybody else with hands raised. I don't believe 16 anybody else has any oral comments that they would 17 like to give. 18 So with that I would like to let 19 everybody know that the record for this hearing 20 will be held open until 5:00 p.m. today for the 21 sole purpose of receiving any additional written 22 comments on the proposed rules. You can send them 23 to my email address. Once again, that is 24 [email protected], 25 [email protected].

Page 35 1 I want to thank you all for attending 2 this public hearing today. The Board will weigh 3 the testimony and evidence that was presented 4 before considering any action on the proposed 5 rules. Any future action by the Board on these 6 proposed rules will be taken at a regular monthly 7 meeting of the Board, which is open to the public 8 and any formal action by the Board will comply with 9 Chapter 119 of the Ohio Revised Code. 10 This public hearing is concluded at 11 2:17 p.m. Thank everyone very much for your time 12 today. 13 - - - 14 (Hearing was concluded at 2:17 p.m.) 15 - - - 16 17 18 19 20 21 22 23 24 25

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Page 36 1 C E R T I F I C A T E 2 3 I do hereby certify that the foregoing is 4 a true and correct transcript of the proceedings 5 taken by me in this matter on Monday, May 17, 2021 6 and carefully compared with my original 7 stenographic notes. 8 9 ______Donna D. Chafins, Registered 10 Professional Reporter, and Notary Public in and for the 11 State of Ohio. 12 My commission expires November 8, 2021. 13 14 15 16 17 18 19 20 21 22 23 24 25

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TRANSCRIPT

Full-sized Pages Proceedings

1 BEFORE THE OHIO MEDICAL BOARD - - - In the Matter of: ) MEDICAL RULES HEARING )

- - - PROCEEDINGS before Kimberly Lee, Hearing Examiner, at the Ohio Medical Board, 30 East Broad Street, Room 336, Columbus, Ohio 43215, called at 1:30 a.m. on Monday, May 17, 2021.

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2 1 APPEARANCES 2 - - - 3 Kimberly Anderson Chief Legal Officer for Medical 4 Board of Ohio 30 East Broad Street 5 Columbus, Ohio 43215 6 On behalf of the Ohio Medical Board 7 8 - - - 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

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3 1 INDEX 2 KIMBERLY ANDERSON Examination by Ms. Lee 08-07 3 EXHIBITS 4 5 State's Ident. Admit 6 1 - Package 189936 08-21 11-16 7 2 - Package 190003 08-21 11-16 8 3 - Package 190004 08-21 11-16 9 4 - Notice of Hearing 08-21 11-16 10 5 - Email List 08-21 11-16 11 6 - Comments 08-21 11-16 12 13 14 15 16 17 18 19 20 21 22 23 24 25

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4 1 Monday, May 17, 2021 2 1:30 p.m. 3 - - - 4 HEARING OFFICER: All right. Good 5 afternoon, everyone. Let's go on the record. This 6 is the public hearing for the State Medical Board 7 of Ohio. It is now in session. Let the record 8 show that this public hearing is convened at 1:32 9 p.m. on Monday, May 17th, 2021, via GoTo Webinar. 10 This public hearing was called pursuant to Section 11 119.03 of the Ohio Revised Code. 12 I am Kimberly Lee, hearing examiner for 13 the State Medical Board of Ohio. I'm conducting 14 this public rules hearing on behalf of the Board. 15 The members of the Board will review the report 16 concerning this hearing including any written 17 materials submitted as evidence and they will also 18 have the transcript of today's hearing available 19 for review. 20 So today the following rules are 21 proposed. In regards to light-based medical 22 devices, we have 4731-18-01, definitions, is a 23 proposed new rule. 24 4731-18-02, use of light-based medical 25 devices is a proposed new rule and also 4731-18-02

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5 1 use of light-based medical devices is proposed to 2 be rescinded. 3 4731-18-03, delegation of the use of 4 light-based medical devices for specified 5 non-ablative procedures is a proposed new rule. 6 And 4731-18-03, delegation of the use of 7 light-based medical devices for specified 8 non-ablative procedures is proposed to be 9 rescinded. 10 4731-18-04, delegation of phototherapy 11 and photodynamic therapy is a proposed new rule. 12 4731-18-04, delegation of phototherapy and 13 photodynamic therapy is proposed to be rescinded. 14 In regard to hearing rules 4731-13-01, 15 representatives appearances is proposed to be 16 amended. 17 4731-13-03, authority and duties of 18 hearing examiners is proposed to be amended. 19 4731-13-06, continuance of hearing is 20 proposed to be amended. 21 4731-13-07, motions is proposed to be 22 amended. 23 4731-13-07.1, form and paid limitations 24 for briefs and memoranda is proposed to be amended. 25 4731-13-08, filing is proposed to be

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6 1 amended. 2 4731-13-09, service is proposed to be 3 amended. 4 4731-13-13, subpoenas for purposes of 5 hearing is proposed to be amended. 6 4731-13-15, reports and recommendations 7 is proposed to be amended. 8 4731-13-16, reinstatement or 9 restoration of certificate is proposed to be 10 amended. 11 4731-13-17, settlements, dismissals and 12 voluntary surrenders is proposed to be amended. 13 4731-13-33, Physicians' Desk Reference 14 is proposed to be amended. 15 And 4731-13-36, disciplinary actions is 16 proposed to be amended. 17 In regards to dietetic's rules, 18 4759-4-04, continuing education is a proposed new 19 rule. 4759-4-04, continuing education is proposed 20 to be rescinded. 21 4759-4-08, limited permit is a proposed 22 new rule. 4759-4-08, limited permit is proposed to 23 be rescinded. 24 And 4759-6-02, standards of 25 professional performance is proposed to be amended.

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7 1 The purpose of this hearing today is to 2 provide an opportunity for any purpose -- for any 3 person, excuse me, affected by the proposed rules 4 to be heard. 5 Any affected person may present his or 6 her positions, arguments or contentions orally or 7 in writing and may present evidence tending to show 8 that the proposed adoption of the rules as proposed 9 will be unreasonable or unlawful. 10 All persons who testify orally today 11 are asked to raise their hands by clicking on the 12 hand icon on their control panel. If you have a 13 written copy of your testimony, submission of the 14 written copy will assist the Board in its review of 15 your comments. Written statements may also be 16 submitted today without testifying. 17 You can send electronic copies of your 18 comments to me and my email address is 19 [email protected]. And I'll repeat that 20 address later in this proceeding, so you don't need 21 to scramble to write it down right now. 22 But I want to now recognize Kim 23 Anderson, Chief Legal Counsel for the Medical Board 24 for the presentation of testimony on the Board's 25 compliance with the legal requirements in this

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8 1 matter. Could you please swear in Miss Anderson. 2 - - - 3 KIMBERLY ANDERSON, 4 being first duly sworn, as provided by law, was 5 examined and testified as follows: 6 EXAMINATION 7 BY MS. LEE:

8 Q. Thank you very much. Could you please 9 state your name and how you are employed? 10 A. Kimberly Anderson, Chief Legal Counsel, 11 State Medical Board of Ohio.

12 Q. Are you familiar with the filings and 13 other actions taken for purposes of the rules being 14 considered today? 15 A. Yes.

16 Q. What part did you play in the filing of 17 the rules? 18 A. I participated in their filing and the 19 distribution of the notice of public hearing. 20 - - - 21 (Board's Exhibits 1 - 6, were marked for 22 purposes of identification.) 23 - - - 24 BY MS. LEE:

25 Q. Can you please identify the documents

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9 1 that have been marked as exhibits? 2 A. Yes. Exhibit 1 is a copy of the rules 3 originally filed in package 189936 with JCARR, 4 Secretary of State and the Legislative Services 5 Commission, via the Electronic Rule-Filing System 6 on April 9th, 2021 and a copy of the confirmation 7 of filing. Also included is a copy of the 8 confirmation of the revised filing on April 16th, 9 2021. 10 Exhibit 2, is a copy of the rules 11 originally filed in package 190003 with JCARR, 12 Secretary of State and the Legislative Services 13 Commission via the Electronic Rule-Filing System on 14 April 12th, 2021, and a copy of the confirmation of 15 filing. Also included is a copy of the 16 confirmation of the revised filings on April 16th, 17 2021 and on May 3rd, 2021. 18 Exhibit 3, is a copy of the rules 19 originally filed in package 190004 with JCARR, 20 Secretary of State and the Legislative Services 21 Commission via the Electronic Rule-Filing System on 22 April 9th, 2021, and a copy of the confirmation of 23 filing. Also included is a copy of the 24 confirmation of the revised filing on April 19th, 25 2021.

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10 1 Q. Thank you. Was public notice of the 2 rules that are the subject of this hearing given to 3 the Registrar of Ohio at least 30 days prior to 4 today? 5 A. Yes. Exhibit 4 is a copy of the notice 6 of public hearing that was filed on April 12th, 7 2021 for rules in packages 189936, 190003, and 8 190004. Also included is a copy of the notice of 9 public hearing refiled on April 16th, 2021 for 10 rules in packages 189936 and 190003 and on April 11 19th, 2021 for rule package 190004.

12 Q. Was notice of the proposed rules 13 provided to any persons or organizations? 14 A. Yes. Exhibit 5 contains copies of the 15 address portion of emails sent to persons and 16 organizations pursuant to their standing request to 17 be notified when the Medical Board proposes rules.

18 Q. Were any requests for copies of the 19 proposed rules received in the Board office? 20 A. No.

21 Q. Were any written comments on the 22 proposed rules received in the Board's office? 23 A. Yes. Exhibit 6 is a copy of the 24 comments received from Jason Lichten; Jessica 25 Watkins, PA of MONA Dermatology; Jen Johns of the

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11 1 Academy of Medicine of Cleveland and Northern Ohio; 2 Scott Cackler; Kelly Ott-Statzer -- Statzer; 3 Stephen Lopez, M.D.; Kay Mavko, of the Ohio Academy 4 of Nutrition and Dietetics; Kristine Good-Bath; 5 Anna Luning, CNP of MONA Dermatology; Mona Foad, of 6 MONA Dermatology; Kelly Wert, Cosmetic Therapy 7 Association of Ohio; Manu Aggarwal; Marty 8 Sweterlitsch, of the Ohio Society of Cosmetic 9 Therapy Training, Vickie Mickey, AboutFace Cosmetic 10 Therapy Training Center; Vickie Mickey, Cosmetic 11 Therapy Training Center; Marley Miller; Amanda 12 Nelson of the Cosmetic Therapy Association of Ohio 13 and Emily Besser of the American Society for 14 Dermatologic Surgery Association. 15 HEARING OFFICER: Thank you very much. 16 Exhibits 1 through 6 are admitted into the record. 17 Thank you, Miss Anderson. 18 THE WITNESS: Thank you. 19 HEARING OFFICER: All right. Now, it 20 is time to receive testimony on the proposed rules 21 from interested party. Please remember that the 22 purpose of this hearing is to receive ideas, 23 comments and concerns regarding the proposed rules. 24 It is not the appropriate time to seek debate on 25 those proposed rules.

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12 1 Moreover, the Board reserves the right 2 to limit the testimony of any witness if the 3 testimony appears to be irrelevant or cumulative. 4 If a witness has a written copy of his 5 or her testimony or other documents that you wish 6 to have marked as exhibits, the documents should be 7 emailed to me at the conclusion of your testimony. 8 If you have a written statement you 9 wish to submit without giving testimony, you can 10 also email that to me so it can be marked as an 11 exhibit. And once again, here is my email address. 12 It is [email protected] that is 13 [email protected]. 14 All right. So if anybody wishes to 15 testify, please, you know, raise your hand on your 16 control panel and we will go from there. 17 I only see one hand raised and that is 18 Marty Sweterlitsch. You are on mute, would you 19 like -- 20 MS. SWETERLITSCH: I'm here. 21 HEARING OFFICER: Can you hear me? 22 MS. SWETERLITSCH: I can hear you. 23 HEARING OFFICER: All right. Thank you 24 very much. Can you please state your name and 25 address for the record?

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13 1 MS. SWETERLITSCH: Absolutely. My full 2 name is Martha J. Sweterlitsch. I'm a partner at 3 Benesch, Friedlander, Coplan and Aronoff. The 4 address is 41 South High Street, Suite 2600, 5 Columbus, Ohio 43215. 6 HEARING OFFICER: Thank you. Are you 7 appearing on behalf of any organization today? 8 MS. SWETERLITSCH: I am appearing on 9 behalf of the Ohio Society of Cosmetic Therapy 10 Training. And we are commenting on -- basically on 11 rule 4731-18-03. Apologize for looking down, but I 12 have to read my testimony and I didn't make the 13 print big enough and that is my fault. 14 HEARING OFFICER: You are totally fine. 15 If it makes you feel any better, the way this 16 program works is that for the commentators the 17 camera is not active, so.... 18 MS. SWETERLITSCH: Okay. So I'm ready 19 to begin if you are. 20 HEARING OFFICER: Yes, ma'am, please 21 proceed. 22 MS. SWETERLITSCH: Okay. And the first 23 thing we want to do is express our gratitude for 24 all of the work that the Board and the staff have 25 done and put into these efforts after the passage

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14 1 of House Bill 442 by the 133rd General Assembly, 2 which effectively removed the regulatory structure 3 for cosmetic therapists over a limited practice of 4 medicine. 5 We understand that the Medical Board 6 had no knowledge of the change prior to the passage 7 of the law and that nearly 200 mostly women-owned 8 businesses that operate in Ohio can continue 9 working because of your quick action and dedicated 10 efforts to help with the emergency rule and we just 11 really do appreciate all the conversations that we 12 have been able to have about that. 13 We have identified four areas of the 14 rule in which our clients believe provide obstacles 15 for the profession of cosmetic therapy today and 16 going forward. 17 We respectfully ask the Board to 18 consider modifying the rules to address these 19 issues as they move through the JCARR process. 20 The first area is the probe 21 electrolysis using electric current on face and 22 body is left unregulated. We recognize that the 23 Medical Board has limited authority after the 24 passage of 442. 25 But from a patient protection

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15 1 perspective and for our clients that care about the 2 professionalism of their industry and the safety of 3 their electrology patients, it is very concerning 4 that electrolysis is left completely unregulated. 5 Whenever you are dealing with an 6 electrical current being delivered within skin to 7 terminate the growth of hair at the dermal papilla, 8 there is a risk of potential burn. 9 If the provider is untrained and 10 inexperienced with no minimum standards of 11 sanitation and hygiene, there is a risk of 12 infection, transmission of disease, break down of 13 the skin and a high risk of burning the skin. It 14 is simply irresponsible in Ohio to leave this 15 profession without any regulation. And we would 16 urge the Medical Board to look at any options that 17 you might have to potentially protect patients 18 under this admittedly very limited practice of 19 medicine. 20 Our second concern is the required 21 physician involvement in the proposed training for 22 light-based technology is prohibitive in the 23 cost -- in terms of its costs and identifying 24 willing physicians. 25 The required physician involvement in

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16 1 the proposed training for therapists under 2 light-based medical devices, lasers in the 3 vernacular for those who are listening, is 4 prohibitive both in terms of cost and identifying 5 willing physicians. 6 As this Board recognizes in proposed 7 Rule 4731-18-02, the application of light-based 8 medical devices to the human body is the practice 9 of medicine, albeit in the case of hair removal by 10 a trained therapist, an area of limited practice 11 but medicine nonetheless. 12 For the uninitiated, we are not talking 13 about the plucking of a few eyebrows or chin hairs 14 for improving appearance. Permanent hair removal 15 is desirable and often necessary to a patient's 16 health and well-being for a variety of reasons, of 17 which I'm sure this Board is aware given your long 18 experience with this area. 19 The training for cosmetic therapists 20 prior to the passage of House Bill 442 was approved 21 by the State Board of Career Colleges and Schools 22 and has adequately trained practitioners for years 23 to allow physicians to safely delegate the use of 24 light-based medical devices for hair removal under 25 the rules that you have in place.

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17 1 The proposed rule contemplates a 2 complicated and excessive training process that 3 requires the active involvement of a practicing 4 physician for each student, including the student 5 observing a physician performing 20 procedures of 6 each type of procedure for hair removal that is 7 delegated and the physician personally observing 15 8 procedures by each student for each type of laser 9 or hair removal that is being delegated. 10 Given that there are multiple types of 11 procedures, the amount of time to be spent by the 12 physician will dramatically increase the cost of 13 the training and that assumes that there will be 14 physicians able and willing to devote the time 15 required. 16 It will be much simpler for the 17 physician to simply delegate to a physician 18 assistant who will not be required to undergo any 19 special training under your rules or under their 20 standards of practice. 21 Under the rule, only cosmetic 22 therapists, R.N.'s and L.P.N.'s are subject to 23 these specific training requirements. In short, 24 the proposed training regimen practically 25 guarantees that no one will be able to enter the

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18 1 profession. 2 We would respectfully request that the 3 Board allow the training to be approved by the 4 State Board of Career Colleges and Schools as is 5 currently the process and allow physicians to 6 safely delegate without the expensive and 7 complicated addition of these provisions. 8 The therapists would simply show the 9 physician proof of successful completion of the 10 required curriculum and national testing, which is 11 already available from several associations. Proof 12 of continuing education can similarly be provided 13 to the delegating physician. 14 This Board could cooperate with the 15 Board of Career Colleges and Schools to assure that 16 the curriculum continues to serve the medical 17 profession because we understand that curriculum 18 has to be relevant and you have to be comfortable 19 with it. 20 Our third area of concern is that there 21 are cosmetic therapy students who are left in limbo 22 because they are in training and they don't have a 23 current license, so they are not grandfathered and 24 there is no provision in the rule for them other 25 than sort of starting over under this new regimen,

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19 1 which may or may not exist. 2 Specifically, it delegates that who 3 have been applying light-based therapy must be 4 active for two years prior to the effective date of 5 this rule. Current students are in limbo as well 6 as licensed CPs, who have not been actively working 7 with the laser during the immediately preceding two 8 years. 9 We respectfully request the Board to 10 modify this provision to accommodate these two 11 categories of current and future cosmetic 12 therapists. I understand you might want some 13 additional continuing education for folks who 14 haven't been active for a time, that is not an 15 unreasonable request to make, but having them start 16 all over again just doesn't seem necessary for 17 either category. 18 Finally in number 4, the off-site 19 supervision should not be limited to 60-minute 20 travel time in terms of the restriction on the 21 physician. 22 Cosmetic therapists cannot do their job 23 if they are delegating physician travels and 24 therefore, their patients don't get served and 25 that's a problem. Because the physicians are not

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20 1 going to be chained to their offices and the 2 patients need help when the patients need help. 3 We respectfully request the removal of 4 the 60-mile limitation. The pandemic has fostered 5 the rise of innovative medical services like 6 telehealth and physicians can adequately assess a 7 patient through electronic means should it be 8 necessary to contact them. 9 And certainly if there is an incident 10 that requires immediate medical attention, we have 11 to send people to Urgent Care or the Emergency Room 12 any way. A physician who is 59 miles away is not 13 going to be able to deal with that. 14 So those are our -- those are our 15 comments on the rule. Again, I want to thank you 16 for the opportunity to offer this testimony on 17 behalf of our client and to work with the Board on 18 hopefully coming up with something that will at 19 least make the situation better for the therapists. 20 I'm happy to answer any questions that 21 you might have with the caveat that I am not a 22 technician of cosmetic therapy. 23 HEARING OFFICER: Thank you very much. 24 I do not have any questions for you, but I do 25 appreciate your comments and we also have your

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings

21 1 written letter as an exhibit as well. 2 MS. SWETERLITSCH: Thank you very much. 3 HEARING OFFICER: Thank you. If 4 anybody else would like to testify today, if you 5 could please raise your hand. 6 I see Natasha Fogle has raised her 7 hand. Miss Fogle, it looks like you are joining by 8 phone and it says you can't be unmuted until you 9 enter a pin. I have told the system to send you 10 the pin, so hopefully we can get that resolved and 11 you can speak here in a moment. Give a minute to 12 try to get that worked out. 13 Does not appear that Miss Fogle is 14 putting in the pin. Give another minute here. And 15 anybody else, if you would like to give comments 16 today, if you could also please raise your hand. 17 I see Miss Fogle has actually sent in a 18 question, says they are having trouble and cannot 19 find the pin. Hold on one moment. Miss Fogle, the 20 pin for you is 53539. I'm sorry, it is pound 53539 21 pound. 22 I don't see any other hands raised 23 other than Miss Fogle, so she is trying to get that 24 resolved. We will give another minute here, so she 25 can give her comments, if possible.

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22 1 We also have Amanda Nelson who would 2 like to speak. Let's go -- Miss Nelson, I'm going 3 to unmute you. It looks like you are self-muted. 4 If you would like to unmute. Miss Nelson, you need 5 an audio pin since you are joining by phone. I'll 6 have it sent to. I'll read it to you as well. It 7 is pound 62693 pound. 8 All right. Looks like Dr. Foad is also 9 trying to speak. 10 DR. FOAD: Hello. Hello. 11 HEARING OFFICER: Hi, Dr. Foad, is that 12 you? 13 DR. FOAD: Yes, can you hear me okay? 14 HEARING OFFICER: Yes. 15 DR. FOAD: I'm so sorry this is 16 difficult. 17 HEARING OFFICER: There is always a 18 problem. Probably need to turn off a speaker 19 somewhere. Now, I'm sure that audio is going on 20 and off, so I believe she is trying to resolve the 21 issue. 22 DR. FOAD: So yes, hello. 23 HEARING OFFICER: Hi, Doctor. 24 DR. FOAD: Can you hear me? 25 HEARING OFFICER: Yes, we can hear you.

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23 1 DR. FOAD: Okay. Great. Sorry about 2 that. Actually Natasha Fogle was trying to get me 3 on because I'm trying to come in from patients. So 4 I apologize for the confusion. 5 HEARING OFFICER: You are fine. If I 6 could real briefly, just before you get going, if 7 you could state your name and address for the 8 record and what organization you are with? 9 DR. FOAD: Absolutely. It is Dr. Mona 10 Foad, F as in Frank O-a-d as in David. I'm with it 11 is Cincinnati Dermatology Center doing business as 12 MONA Dermatology and our address is 7730 Montgomery 13 Road, Cincinnati, Ohio 45236. 14 HEARING OFFICER: All right. Thank 15 you. Please go ahead, Doctor. 16 DR. FOAD: Okay. Wonderful. Well, I 17 have employed physician assistants and nurse 18 practitioners for the last 19 years. And I 19 actually train them in dermatology. 20 And I know that Jessica Watkins has 21 sent in a letter and I have sent in a letter kind 22 of discussing why we feel that especially in the 23 field of dermatology, it is very useful for 24 physician assistants to be able to treat their 25 patients with light-based therapies.

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24 1 In our letter, we included a couple of 2 scenarios in which it actually takes away from 3 their ability to take care of patients. Can you 4 hear me? Can you still hear me? 5 HEARING OFFICER: Yes, ma'am. 6 DR. FOAD: Okay. Wonderful. So, for 7 example, in dermatology and this is not in 8 cosmetics, it is just simply in dermatology, 9 medical dermatology. You will have a patient to 10 treat warts, for example. And one of the 11 treatments that we use every day to treat warts is 12 a pulse dye laser called VBeam laser. 13 And so what ends up happening is 14 repeatedly our physician assistants then cannot 15 treat those patients with a VBeam and they will end 16 of using cryotherapy or, for example, doing, you 17 know, salasylic acid. But there are times where 18 you really are going to better serve the patient in 19 using a laser to treat that wart. 20 So what ends up happening is that then 21 physician assistant ends up having to reschedule 22 the patient on to either my schedule or a nurse 23 practitioner's schedule and then the patient has to 24 leave. They have to come back and frankly, I just 25 don't think it is in the patient's best care and it

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25 1 also takes away their confidence in their physician 2 assistant. 3 Another example in dermatology and 4 where we end up using light-based treatment often 5 is in rosacea. So you will have a patient come in. 6 They will have rosacea. You can go through, you 7 know, different prescriptions and skin care options 8 and invariably a lot of them want to have something 9 that treats it faster. 10 And so we can either do again, a VBeam 11 or something called intense pulse light, which is 12 another light-based therapy and again, that patient 13 has to be sent to either an M.D. or an NP in order 14 to treat them. 15 So I feel like those are two examples 16 where it really would help patient care for 17 physician assistants to be able to use these lasers 18 and lights and it also, as I said, helps the 19 confidence in the patient. Because you could be 20 treating them for all of their medical concerns and 21 if you aren't able to further your treatment 22 because you don't have the ability to, I feel like 23 it takes away from the confidence that the patient 24 would have in their provider. 25 In addition, I feel that -- I

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26 1 understand that physician assistants and NP's have 2 a different background in how they get to be 3 providers of patient care, but I don't feel that -- 4 I guess, I don't really understand why there is a 5 limitation on physician assistants when nurse 6 practitioners have the same ability to be able to 7 treat their patients with light-based devices and 8 lasers. Was I too long winded? 9 HEARING OFFICER: No, you were fine. I 10 wanted -- I didn't want to speak up if you had any 11 further comments, Dr. Foad. 12 DR. FOAD: Yeah. Now, I do think that 13 there is a difference, frankly, between a physician 14 assistant, for example, or an L.P.N. or a medical 15 assistant or an esthetician, right. They 16 definitely have more training. And I feel like, 17 you know, when looking at the rule, I feel like 18 they should be in a category that is their own and 19 they should not be lumped in, for example, with 20 L.P.N.'s or medical assistants or estheticians. 21 And, frankly, I know that the ruling 22 changed for injectables several years ago. So to 23 be able to use an injectable like Botox or filler 24 or Kybella or any of the injectables that are on 25 the market, they are able to use those things.

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27 1 Well, as long as they have training for 2 laser and light-based devices, I feel like they 3 should be able to do the same thing. 4 HEARING OFFICER: Are those all your 5 comments, Dr. Foad? 6 DR. FOAD: I believe so. 7 HEARING OFFICER: Okay. Just wanted to 8 make sure. 9 DR. FOAD: I hope that helps. 10 HEARING OFFICER: It is very helpful. 11 Thank you. I know it is hard when we do these over 12 the Internet, but I don't want to step on you if 13 you have anything further to say. 14 DR. FOAD: No, no. Like I said, I 15 think that the number one reason is it is in the 16 patient's best interest, that is always the most 17 important thing. 18 I think number 2, it takes away from 19 the confidence of the patient to their provider 20 because they can't do certain things. 21 I think number 3, the training with 22 physician assistants and nurse practitioners, 23 although they reach the same end goal, they 24 effectively are able to treat patients in the same 25 way and so I feel like there should not be that

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings

28 1 limitation for physician assistants when there 2 isn't one for nurse practitioners. 3 So that's it. I really appreciate your 4 time and I'm so sorry that it was so difficult to 5 get us on. 6 HEARING OFFICER: I appreciate your 7 comments, Dr. Foad, and my apologies that you 8 experienced difficulties. 9 DR. FOAD: Yeah, thank you so much. 10 HEARING OFFICER: Have a good day. 11 DR. FOAD: I hope you have a good rest 12 of your meeting. All right. Bye-bye. 13 HEARING OFFICER: Bye. All right. Is 14 there anybody else that would like to give comments 15 today, if you could raise your hand. 16 All right. Looks like Amanda Nelson 17 would like to speak. Miss Nelson, if you could 18 unmute yourself. 19 MS. NELSON: Hi. Thank you very much. 20 Can you hear me? 21 HEARING OFFICER: Yes, we can hear you. 22 If you could just please state your name and the 23 address for the record and if you are representing 24 an organization, please state that as well. 25 MS. NELSON: Yes, I am Amanda Nelson

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29 1 and I am president of the Cosmetic Therapy 2 Association of Ohio. Our address is Cosmetic -- 3 HEARING OFFICER: Wait, wait, one 4 second. 5 MS. NELSON: I'm sorry. 6 HEARING OFFICER: My apologies, we lost 7 you for just one moment there. 8 MS. NELSON: Okay. My name is Amanda 9 Nelson. I'm the president of the Cosmetic Therapy 10 Association of Ohio. And we are a non-profit 11 organization supporting the profession of cosmetic 12 therapy. Our contact information is 13 [email protected]. And we submitted a 14 letter over the weekend regarding our comments on 15 this rule as well. 16 So I do appreciate you allowing an 17 opportunity for us to speak and I apologize if I 18 continue to have any additional technical 19 difficulties because I was having some trouble as 20 well. 21 HEARING OFFICER: No worries. 22 MS. NELSON: So I do want to echo one 23 sentiment that I had heard earlier about the 24 physician off-site supervision being limited to 25 60-mile radius is rather burdensome.

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30 1 It is very common that our clients are 2 traveling over an hour to get our services. There 3 is only 185 cosmetic therapists in the state and 4 especially in rural areas, there is -- it is 5 certainly not uncommon for our clients to drive two 6 to three hours for our services. 7 So having a physician be required to be 8 closer than they are, certainly provided some 9 conflicts in the past. One thing that I think 10 could help remedy the situation is we can utilize 11 some teleconference or telemedicine when it comes 12 to this aspect a little bit because cosmetic 13 therapy does go through the most rigorous amount of 14 training than any of the other delegated 15 professions. 16 I'm satisfied with the training 17 outlined as they are proposed. It is my 18 interpretation that the observation treatments and 19 simply advised treatments actually occur with the 20 doctor who is your long-term relationship, that you 21 have a business relationship with. That is the 22 doctor who is actually going to be delegating to 23 you as a business. So it is not something that 24 would happen during the school. 25 However, one issue that we come across

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31 1 is that doctors who are contracted with hospital 2 systems are not capable to have business 3 relationships outside of those hospital systems. 4 So finding an independent doctor can be 5 very difficult. And the thing that ties into that 6 is physicians supervising two cosmetic therapists 7 at a time. 8 So again, with the light-based therapy 9 being a small field, the requirement of having to 10 be supervised by one doctor would help us 11 immensely. Because there are about a dozen 12 cosmetic therapy based businesses that do thrive. 13 They get more facilities or they have more 14 certifications or multiple counties and oftentimes, 15 we still only have that one or maybe two, three, if 16 we are lucky, three is the maximum amount of 17 doctors that our small businesses would ever be 18 able to establish relationships with and move 19 forward. 20 So it is very unlikely that we would 21 ever be in a scenario where one doctor would be 22 supervising an appropriate amount of cosmetic 23 therapists. To supervise up to dozen is very 24 unlikely. 25 So, you know, all I'm asking for by

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings

32 1 removing this part of the rule, is really to just 2 allow this small businesses to, you know, hire 3 within our own field. For cosmetic therapists who 4 are coming into this field, they are going to have 5 an opportunity to be in a licensed profession, that 6 they are considered competent because these 7 grandfathered cosmetic therapists, if you will, 8 will support the younger profession and we will 9 hire within our own. And any one of our businesses 10 really only support up to half a dozen cosmetic 11 therapists on the staff across, you know, two or 12 three locations. 13 And then the only other thing that I 14 really want to drive home is that in December of 15 2020 before House Bill came up that unlicensed our 16 profession, Dr. Bechtel was very competent in our 17 ability to do delegated vascular laser treatments 18 which are typically like -- 19 HEARING OFFICER: Miss Nelson. 20 MS. NELSON: Series of laser -- 21 HEARING OFFICER: Miss Nelson. 22 MS. NELSON: Yeah. 23 HEARING OFFICER: I'm sorry to 24 interrupt you. Your sentences broke up. 25 MS. NELSON: I broke up. Yeah, I'm

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings

33 1 sorry, let me move to another location. 2 So yes, I was just saying that, you 3 know, Dr. Bechtel supported the cosmetic therapy 4 profession, the vascular treatments prior to my 5 license, but having House Bill 2 that was supposed 6 to be removed from the list and so considering that 7 he is a president and that he is a dermatologist 8 and that he would know better than almost any other 9 physician in the state about the safety of vascular 10 laser treatments, we would strongly recommend that 11 we be included in that as well. 12 And I think from the future forward 13 because again, our businesses are so small. So the 14 amount of services that we can incorporate into our 15 practices is such that it would be an economic 16 fallout of a post-Covid society, you know, any 17 little bit would help. We already have that 18 established relationship with the doctor. 19 So basically the training requirements 20 are already in place with the eight hours of 21 education and then it would just require the 15, 22 the 20 observations or supervised treatments for 23 some treatments or for vascular treatments in 24 addition to the 15 to 20 observation and supervised 25 treatment for laser hair removal.

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34 1 So I do think that the amount of 2 doctors that would come to us if they knew that we 3 had a wider range of treatments that we could 4 provide them. 5 That covers most of what I wanted to 6 say. 7 HEARING OFFICER: Okay. Thank you very 8 much, Miss Nelson. I appreciate you taking the 9 time to give comments this afternoon. 10 MS. NELSON: Thank you so much. 11 HEARING OFFICER: All right. If 12 anybody else would like to give a comment, if you 13 could please raise your hand. Just looking at the 14 list. Give it another moment here. I'm not seeing 15 anybody else with hands raised. I don't believe 16 anybody else has any oral comments that they would 17 like to give. 18 So with that I would like to let 19 everybody know that the record for this hearing 20 will be held open until 5:00 p.m. today for the 21 sole purpose of receiving any additional written 22 comments on the proposed rules. You can send them 23 to my email address. Once again, that is 24 [email protected], 25 [email protected].

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35 1 I want to thank you all for attending 2 this public hearing today. The Board will weigh 3 the testimony and evidence that was presented 4 before considering any action on the proposed 5 rules. Any future action by the Board on these 6 proposed rules will be taken at a regular monthly 7 meeting of the Board, which is open to the public 8 and any formal action by the Board will comply with 9 Chapter 119 of the Ohio Revised Code. 10 This public hearing is concluded at 11 2:17 p.m. Thank everyone very much for your time 12 today. 13 - - - 14 (Hearing was concluded at 2:17 p.m.) 15 - - - 16 17 18 19 20 21 22 23 24 25

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WORD INDEX

Proceedings Page 1

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Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings Page 4

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Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings Page 5 please 8:1,8,25 18:5 pursuant 4:10 29:14 respectfully 14:17 11:21 12:15,24 profession 14:15 10:16 regards 4:21 6:17 18:2 19:9 20:3 13:20 21:5,16 15:15 18:1,17 put 13:25 regimen 17:24 rest 28:11 23:15 28:22,24 29:11 32:5,8,16 putting 21:14 18:25 restoration 6:9 34:13 33:4 Registered 36:9 restriction 19:20 plucking 16:13 professional 6:25 Q Registrar 10:3 review 4:15,19 7:14 portion 10:15 36:10 question 21:18 regular 35:6 revised 4:11 9:8,16 positions 7:6 professionalism questions 20:20,24 regulation 15:15 9:24 35:9 possible 21:25 15:2 quick 14:9 regulatory 14:2 right 4:4 7:21 post-Covid 33:16 professions 30:15 reinstatement 6:8 11:19 12:1,14,23 R potential 15:8 program 13:16 relationship 30:20 22:8 23:14 26:15 potentially 15:17 prohibitive 15:22 R 36:1 30:21 33:18 28:12,13,16 34:11 pound 21:20,21 16:4 R.N.'s 17:22 relationships 31:3 rigorous 30:13 22:7,7 proof 18:9,11 radius 29:25 31:18 rise 20:5 practically 17:24 proposed 4:21,23 raise 7:11 12:15 relevant 18:18 risk 15:8,11,13 practice 14:3 15:18 4:25 5:1,5,8,11,13 21:5,16 28:15 remedy 30:10 Road 23:13 16:8,10 17:20 5:15,18,20,21,24 34:13 remember 11:21 Room 1:9 20:11 practices 33:15 5:25 6:2,5,7,9,12 raised 12:17 21:6 removal 16:9,14,24 rosacea 25:5,6 practicing 17:3 6:14,16,18,19,21 21:22 34:15 17:6,9 20:3 33:25 rule 4:23,25 5:5,11 practitioner's 6:22,25 7:3,8,8 range 34:3 removed 14:2 33:6 6:19,22 10:11 24:23 10:12,19,22 11:20 reach 27:23 removing 32:1 13:11 14:10,14 practitioners 16:22 11:23,25 15:21 read 13:12 22:6 repeat 7:19 16:7 17:1,21 23:18 26:6 27:22 16:1,6 17:1,24 ready 13:18 repeatedly 24:14 18:24 19:5 20:15 28:2 30:17 34:22 35:4 real 23:6 report 4:15 26:17 29:15 32:1 preceding 19:7 35:6 really 14:11 24:18 Reporter 36:10 Rule-Filing 9:5,13 prescriptions 25:7 proposes 10:17 25:16 26:4 28:3 reports 6:6 9:21 present 7:5,7 protect 15:17 32:1,10,14 representatives rules 1:4 4:14,20 presentation 7:24 protection 14:25 reason 27:15 5:15 5:14 6:17 7:3,8 presented 35:3 provide 7:2 14:14 reasons 16:16 representing 28:23 8:13,17 9:2,10,18 president 29:1,9 34:4 receive 11:20,22 request 10:16 18:2 10:2,7,10,12,17 33:7 provided 8:4 10:13 received 10:19,22 19:9,15 20:3 10:19,22 11:20,23 print 13:13 18:12 30:8 10:24 requests 10:18 11:25 14:18 16:25 prior 10:3 14:6 provider 15:9 receiving 34:21 require 33:21 17:19 34:22 35:5 16:20 19:4 33:4 25:24 27:19 recognize 7:22 required 15:20,25 35:6 Probably 22:18 providers 26:3 14:22 17:15,18 18:10 ruling 26:21 probe 14:20 provision 18:24 recognizes 16:6 30:7 rural 30:4 problem 19:25 19:10 recommend 33:10 requirement 31:9 22:18 provisions 18:7 recommendations requirements 7:25 S procedure 17:6 public 4:6,8,10,14 6:6 17:23 33:19 safely 16:23 18:6 procedures 5:5,8 8:19 10:1,6,9 35:2 record 4:5,7 11:16 requires 17:3 20:10 safety 15:2 33:9 17:5,8,11 35:7,10 36:10 12:25 23:8 28:23 reschedule 24:21 salasylic 24:17 proceed 13:21 pulse 24:12 25:11 34:19 rescinded 5:2,9,13 sanitation 15:11 proceeding 7:20 purpose 7:1,2 Reference 6:13 6:20,23 satisfied 30:16 proceedings 1:7 11:22 34:21 refiled 10:9 reserves 12:1 saying 33:2 36:4 purposes 6:4 8:13 regard 5:14 resolve 22:20 says 21:8,18 process 14:19 17:2 8:22 regarding 11:23 resolved 21:10,24 scenario 31:21

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings Page 6 scenarios 24:2 sorry 21:20 22:15 supervised 31:10 11:20 12:2,3,5,7,9 Town 1:19 schedule 24:22,23 23:1 28:4 29:5 33:22,24 13:12 20:16 35:3 train 23:19 school 30:24 32:23 33:1 supervising 31:6,22 testing 18:10 trained 16:10,22 Schools 16:21 18:4 sort 18:25 supervision 19:19 thank 8:8 10:1 training 11:9,10,11 18:15 South 13:4 29:24 11:15,17,18 12:23 13:10 15:21 16:1 Scott 11:2 speak 21:11 22:2,9 support 32:8,10 13:6 20:15,23 16:19 17:2,13,19 scramble 7:21 26:10 28:17 29:17 supported 33:3 21:2,3 23:14 17:23,24 18:3,22 second 1:19 15:20 speaker 22:18 supporting 29:11 27:11 28:9,19 26:16 27:1,21 29:4 special 17:19 supposed 33:5 34:7,10 35:1,11 30:14,16 33:19 Secretary 9:4,12,20 specific 17:23 sure 16:17 22:19 therapies 23:25 transcript 4:18 Section 4:10 Specifically 19:2 27:8 therapist 16:10 36:4 see 12:17 21:6,17 specified 5:4,7 Surgery 11:14 therapists 14:3 transmission 15:12 21:22 spent 17:11 surrenders 6:12 16:1,19 17:22 travel 19:20 seeing 34:14 staff 13:24 32:11 swear 8:1 18:8 19:12,22 traveling 30:2 seek 11:24 standards 6:24 Sweterlitsch 11:8 20:19 30:3 31:6 travels 19:23 self-muted 22:3 15:10 17:20 12:18,20,22 13:1 31:23 32:3,7,11 treat 23:24 24:10 send 7:17 20:11 standing 10:16 13:2,8,18,22 21:2 therapy 5:11,13 24:11,15,19 25:14 21:9 34:22 start 19:15 sworn 8:4 11:6,9,10,11,12 26:7 27:24 sent 10:15 21:17 starting 18:25 system 9:5,13,21 13:9 14:15 18:21 treating 25:20 22:6 23:21,21 state 4:6,13 8:9,11 21:9 19:3 20:22 25:12 treatment 25:4,21 25:13 9:4,12,20 12:24 systems 31:2,3 29:1,9,12 30:13 33:25 sentences 32:24 16:21 18:4 23:7 31:8,12 33:3 treatments 24:11 sentiment 29:23 28:22,24 30:3 T thing 13:23 27:3,17 30:18,19 32:17 Series 32:20 33:9 36:11 T 36:1,1 30:9 31:5 32:13 33:4,10,22,23,23 serve 18:16 24:18 State's 3:5 take 24:3 things 26:25 27:20 34:3 served 19:24 statement 12:8 taken 8:13 35:6 think 24:25 26:12 treats 25:9 service 6:2 statements 7:15 36:5 27:15,18,21 30:9 trouble 21:18 29:19 services 9:4,12,20 Statzer 11:2 takes 24:2 25:1,23 33:12 34:1 true 36:4 20:5 30:2,6 33:14 stenographic 36:7 27:18 third 18:20 try 21:12 session 4:7 step 27:12 talking 16:12 three 30:6 31:15,16 trying 21:23 22:9 settlements 6:11 Stephen 11:3 technical 29:18 32:12 22:20 23:2,3 short 17:23 Street 1:9,19 2:4 technician 20:22 thrive 31:12 turn 22:18 show 4:8 7:7 18:8 13:4 technology 15:22 ties 31:5 two 19:4,7,10 25:15 similarly 18:12 strongly 33:10 teleconference time 11:20,24 17:11 30:5 31:6,15 simpler 17:16 structure 14:2 30:11 17:14 19:14,20 32:11 simply 15:14 17:17 student 17:4,4,8 telehealth 20:6 28:4 31:7 34:9 type 17:6,8 18:8 24:8 30:19 students 18:21 19:5 telemedicine 30:11 35:11 types 17:10 situation 20:19 subject 10:2 17:22 tending 7:7 times 24:17 typically 32:18 30:10 submission 7:13 terminate 15:7 today 4:20 7:1,10 skin 15:6,13,13 submit 12:9 terms 15:23 16:4 7:16 8:14 10:4 U 25:7 submitted 4:17 19:20 13:7 14:15 21:4 uncommon 30:5 small 31:9,17 32:2 7:16 29:13 testified 8:5 21:16 28:15 34:20 undergo 17:18 33:13 subpoenas 6:4 testify 7:10 12:15 35:2,12 understand 14:5 society 11:8,13 successful 18:9 21:4 today's 4:18 18:17 19:12 26:1 13:9 33:16 Suite 13:4 testifying 7:16 told 21:9 26:4 sole 34:21 supervise 31:23 testimony 7:13,24 totally 13:14 uninitiated 16:12

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481 Proceedings Page 7 unlawful 7:9 Wert 11:6 119.03 4:11 4731-13-06 5:19 unlicensed 32:15 wider 34:3 12th 9:14 10:6 4731-13-07 5:21 unmute 22:3,4 willing 15:24 16:5 133rd 14:1 4731-13-07.1 5:23 28:18 17:14 15 17:7 33:21,24 4731-13-08 5:25 unmuted 21:8 winded 26:8 16th 9:8,16 10:9 4731-13-09 6:2 unreasonable 7:9 wish 12:5,9 17 1:11 4:1 36:5 4731-13-13 6:4 19:15 wishes 12:14 17th 4:9 4731-13-15 6:6 unregulated 14:22 witness 11:18 12:2 185 30:3 4731-13-16 6:8 15:4 12:4 189936 3:6 9:3 10:7 4731-13-17 6:11 untrained 15:9 women-owned 10:10 4731-13-33 6:13 urge 15:16 14:7 19 23:18 4731-13-36 6:15 Urgent 20:11 Wonderful 23:16 190003 3:7 9:11 4731-18-01 4:22 use 4:24 5:1,3,6 24:6 10:7,10 4731-18-02 4:24,25 16:23 24:11 25:17 work 13:24 20:17 190004 3:8 9:19 16:7 26:23,25 worked 21:12 10:8,11 4731-18-03 5:3,6 useful 23:23 working 14:9 19:6 19th 9:24 10:11 13:11 utilize 30:10 works 13:16 4731-18-04 5:10,12 worries 29:21 2 4759-4-04 6:18,19 V write 7:21 2 3:7 9:10 27:18 4759-4-08 6:21,22 variety 16:16 writing 7:7 33:5 4759-6-02 6:24 vascular 32:17 33:4 written 4:16 7:13 2:17 35:11,14 33:9,23 7:14,15 10:21 20 17:5 33:22,24 5 VBeam 24:12,15 12:4,8 21:1 34:21 200 14:7 5 3:10 10:14 25:10 2020 32:15 5:00 34:20 vernacular 16:3 X 2021 1:11 4:1,9 9:6 53539 21:20,20 Vickie 11:9,10 9:9,14,17,17,22 59 20:12 voluntary 6:12 Y 9:25 10:7,9,11 Yeah 26:12 28:9 36:5,12 6 W 32:22,25 222 1:19 6 3:11 8:21 10:23 wait 29:3,3 years 16:22 19:4,8 223-9481 1:20 11:16 want 7:22 13:23 23:18 26:22 2600 13:4 60-mile 20:4 29:25 19:12 20:15 25:8 younger 32:8 60-minute 19:19 26:10 27:12 29:22 3 614)224-9481 1:20 32:14 35:1 Z 3 3:8 9:18 27:21 62693 22:7 wanted 26:10 27:7 30 1:9 2:4 10:3 0 34:5 336 1:9 7 wart 24:19 08-07 3:2 3rd 9:17 7730 23:12 warts 24:10,11 08-21 3:6,7,8,9,10 8 Watkins 10:25 3:11 4 4 3:9 10:5 19:18 8 36:12 23:20 1 way 13:15 20:12 41 13:4 800 1:20 1 3:6 8:21 9:2 11:16 27:25 43215 1:10 2:5 13:5 1:30 1:10 4:2 9 Webinar 4:9 43215-4620 1:20 1:32 4:8 9th 9:6,22 weekend 29:14 442 14:1,24 16:20 11-16 3:6,7,8,9,10 35:2 45236 23:13 weigh 3:11 well-being 16:16 4731-13-01 5:14 119 35:9 4731-13-03 5:17

Armstrong & Okey, Inc. - www.aando.com - 614-224-9481

EXHIBITS

*** DRAFT - NOT YET FILED *** 4731-18-01 Definitions.

As used in this chapter of the Administrative Code:

(A) “Light based medical device ” means any device that can be made to produce or amplify electromagnetic radiation at wavelengths equal to or greater than one hundred eighty nm but less than or equal to 1.0 X 10 6nm [ten to the sixth power] and that is manufactured, designed, intended or promoted for irradiation of any part of the human body for the purpose of affecting the structure or function of the body.

(B) “Phototherapy” means the following:

(1) For paragraph (A) of rule 4731-18-04 of the Administrative Code, phototherapy means the application of light for the treatment of hyperbilirubinemia in neonates.

(2) For paragraphs (B) and (C) of rule 4731-18-04 of the Administrative Code, phototherapy means the application of ultraviolet light for the treatment of psoriasis and similar skin diseases. This application can occur with any device cleared or approved by the United States food and drug administration for the indicated use that can be made to produce irradiation with broadband ultraviolet B (290-320nm), narrowband ultraviolet B (311-313 nm), excimer light based (308nm), ultraviolet A1 (340-400nm), or UVA (320-400nm) plus oral psoralen called PUVA.

(C) “Photodynamic therapy” means light therapy involving the activation of a photosensitizer by visible light in the presence of oxygen, resulting in the creation of reactive oxygen species, which selectively destroy the target tissue.

(D) “Ablative dermatologic procedure” means a dermatologic procedure that is expected to excise, burn, or vaporize the skin below the dermo-epidermal junction.

(E) “Non-ablative dermatologic procedure” means a dermatologic procedure that is not expected or intended to excise, burn, or vaporize the epidermal surface of the skin.

(F) “Physician means a person authorized to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery under Chapter 4731. and acting within the scope of their practice.

(G) “Delegation” means the assignment of the performance of a service to a person who is not a physician.

(H) “On-site supervision” means the physical presence of the supervising physician is required in the same location (i.e., the physician's office suite) as the delegate of the light based medical device but does not require the physician’s presence in the same room.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Mar 12, 2021 12:00, (dv: 0] print date: 03/12/2021 01:47 PM Exhibit 1 1 *** DRAFT - NOT YET FILED *** 4731-18-01 2

(I) “Off-site supervision” means that the supervising physician shall be continuously available for direct communication with the cosmetic therapist and must be in a location that under normal conditions is not more than sixty minutes travel time from the cosmetic therapist's location.

(J) “Vascular laser” means light-based medical devices including lasers and intense pulsed light apparatuses whose primary cutaneous target structures are telangiectasia, venulectasia, and superficial cutaneous vascular structures. In general, these lasers have wavelengths that correspond to the hemoglobin absorption spectrum.

Exhibit 1 2 *** DRAFT - NOT YET FILED *** 4731-18-02 Use of light based medical devices.

(A) The application of light based medical devices to the human body is the practice of medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery.

(B) A physician shall not delegate the application of light based medical devices for ablative procedures.

(C) A physician may delegate the application of a vascular laser for non-ablative dermatologic procedures according to the requirements in paragraph (A) of rule 4731-18- 03 of the Administrative Code.

(D) A physician may delegate the application of light based medical devices for the purpose of hair removal according to the respective requirements in paragraphs (B) and (C) of rule 4731-18-03 of the Administrative Code.

(E) A physician may delegate the application of phototherapy for the treatment of hyperbilirubinemia in neonates according to the requirements in paragraph (A) of rule 4731-18-04 of the Administrative Code.

(F) A physician may delegate the application of phototherapy and photodynamic therapy only for dermatologic purposes according to the requirements of paragraphs (B) and (C) of rule 4731-18-04 of the Administrative Code.

(G) A violation of paragraph (B) of this rule shall constitute "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code and "violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board," as that clause is used in division (B)(20) of section 4731.22 of the Revised Code, to wit: section 4731.41 of the Revised Code.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Apr 7, 2021 11:21, (dv: 0] print date: 04/07/2021 11:21 AM Exhibit 1 3 To Be Rescinded *** DRAFT - NOT YET FILED *** 4731-18-02 Use of light based medical devices.

(A) For purposes of this rule, light based medical device shall mean any device that can be made to produce or amplify electromagnetic radiation at wavelengths equal to or greater than one hundred eighty nm but less than or equal to 1.0 X 106nm and that is manufactured, designed, intended or promoted for in vivo irradiation of any part of the human body for the purpose of affecting the structure or function of the body.

(B) The application of light based medical devices to the human body is the practice of medicine and surgery, osteopathic medicine and surgery and podiatric medicine and surgery.

(C) Except as provided in rule 4731-18-03 and rule 4731-18-04 of the Administrative Code, no physician licensed pursuant to Chapter 4731. of the Revised Code shall delegate the application of light based medical devices to the human body to any person not authorized to practice medicine and surgery, osteopathic medicine and surgery or podiatric medicine and surgery pursuant to Chapter 4731. of the Revised Code.

(D) A violation of paragraph (C) of this rule shall constitute "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code and "violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board," as that clause is used in division (B)(20) of section 4731.22 of the Revised Code, to wit: section 4731.41 of the Revised Code.

[ stylesheet: rule.xsl 2.14, (dv: 0] print date: 03/12/2021 01:48 PM Exhibit 1 4 *** DRAFT - NOT YET FILED *** 4731-18-03 Delegation of the use of light based medical devices for specified non-ablative procedures.

(A) A physician may delegate the application of a vascular laser for non-ablative dermatologic procedures only if all the following conditions are met:

(1) The vascular laser has been specifically cleared or approved by the United States food and drug administration for the specific intended non-ablative dermatologic procedure;

(2) The use of the vascular laser for the specific non-ablative dermatologic use is within the physician's normal course of practice and expertise;

(3) The physician has seen and evaluated the patient to determine whether the proposed application of the specific vascular laser is appropriate;

(4) The physician has seen and evaluated the patient following the initial application of the specific vascular laser, but prior to any continuation of treatment in order to determine that the patient responded well to the initial application of the specific vascular laser;

(5) The person to whom the delegation is made is one of the following:

(a) A physician assistant licensed under Chapter 4730. of the Revised Code with whom the physician has an effective supervision agreement authorizing the service; or,

(b) A registered nurse or licensed practical nurse licensed under Chapter 4723. of the Revised Code;

(6) For a physician assistant, the authorization must meet the requirements of Chapter 4730.21 of the Revised Code.

(7) For a registered nurse or licensed practical nurse, the physician must ensure that the person to whom the delegation is made has received adequate education and training to provide the level of skill and care required including;

(a) Eight (8) hours of basic education that must include the following topics: light based procedure physics, tissue interaction in light based procedures, light based procedure safety including use of proper safety equipment, clinical application of light based procedures, pre and post-operative care of light based procedure patients, and reporting of adverse events;

(b) Observation of fifteen (15) procedures for each specific type of vascular laser non-ablative procedure delegated. The procedures observed must be performed by 5 a physician for whom the use of this specific vascular laser procedure is within the physician’s normal course of

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Mar 12, 2021 12:10, (dv: 0] print date: 03/12/2021 01:51 PM Exhibit 1 5 *** DRAFT - NOT YET FILED *** 4731-18-03 2

practice and expertise; and

(c) Performance of twenty (20) procedures under the direct physical oversight of the physician on each specific type of vascular laser non-ablative procedure delegated. The physician overseeing the performance of these procedures must use this specific vascular laser procedure within the physician’s normal course of practice and expertise;

(d) Satisfactory completion of training shall be documented and retained by each physician delegating and the delegate. The education requirement in (a) must only be completed once by the delegate regardless of the number of types of specific vascular laser procedures delegated and the number of delegating physicians. The training requirements in (b) and (c) must be completed by the delegate once for each specific type of vascular laser procedure delegated regardless of the number of delegating physician;

(8) For delegation to a registered nurse or licensed practical nurse, the physician provides on-site supervision at all times that the person to whom the delegation is made is applying the vascular laser; and,

(9) For delegation to a registered nurse or licensed practical nurse, the physician supervises no more than two persons pursuant to this rule at the same time.

(B) A physician may delegate the application of light based medical devices for the purpose of hair removal only if all the following conditions are met:

(1) The light based medical device has been specifically cleared or approved by the United States food and drug administration for the removal of hair from the human body;

(2) The use of the light based medical device for the purpose of hair removal is within the physician's normal course of practice and expertise;

(3) The physician has seen and evaluated the patient to determine whether the proposed application of the specific light based medical device is appropriate;

(4) The physician has seen and evaluated the patient following the initial application of the specific light based medical device, but prior to any continuation of treatment in order to determine that the patient responded well to that initial application of the specific light based medical device;

(5) The person to whom the delegation is made is one of the following:

(a) A physician assistant licensed under Chapter 4730. of the Revised Code with whom the physician has an effective supervision agreement authorizing the service;

Exhibit 1 6 *** DRAFT - NOT YET FILED *** 4731-18-03 3

(b) A cosmetic therapist who was licensed under Chapter 4731. of the Revised Code on April 11, 2021 or who has completed a cosmetic therapy course of instruction for a minimum of 750 clock hours and received a passing score on the Certified Laser Hair Removal Professional ® Examination administered by “The Society for Clinical and Medical Hair Removal”; or,

(6) For a physician assistant, the authorization must meet the requirements of Chapter 4730.21 of the Revised Code.

(7) For cosmetic therapists, registered nurses and licensed practical nurses, the physician shall ensure the person to whom the delegation is made has received adequate education and training to provide the level of skill and care required including:

(b) Observation of fifteen (15) procedures for each specific type of light based medical device procedure for hair removal delegated. The procedures observed must be performed by a physician for whom the use of this specific light based medical device procedure for hair removal is within the physician’s normal course of practice and expertise; and

(c) Performance of twenty (20) procedures under the direct physical oversight of the physician on each specific type of light based medical device procedure for hair removal delegated. The physician overseeing the performance of these procedures must use this specific light based medical device procedure for hair removal within the physician’s normal course of practice and expertise;

(d) Satisfactory completion of training shall be documented and retained by each physician delegating and the delegate. The education requirement in (a) must only be completed once by the delegate regardless of the number of types of specific light based medical device procedures for hair removal delegated and the number of delegating physicians. The training requirements of (b) and (c) must be completed by the delegate once for each specific type of light based medical device procedure for

Exhibit 1 7 *** DRAFT - NOT YET FILED *** 4731-18-03 4

hair removal delegated regardless of the number of delegating physicians;

(e) Delegates who, prior to the effective date of this rule, have been applying a specific type of light based medical device procedure for hair removal for at least two (2) years through a lawful delegation by a physician, shall be exempted from the education and training requirements of (a), (b), and (c) for that type of procedure provided that they obtain a written certification from one of their current delegating physicians stating that the delegate has received sufficient education and training to competently apply that type of light based medical device procedure. This written certification must be completed no later than sixty (60) days after the effective date of this provision, and a copy of the certification shall be retained by each delegating physician and each delegate.

(8) For cosmetic therapists, registered nurses and licensed practical nurses, the physician provides on-site supervision at all times that the person to whom the delegation is made is applying the light based medical device; and,

(9) For cosmetic therapists, registered nurses and licensed practical nurses, the physician supervises no more than two persons pursuant to this rule at the same time.

(C) Notwithstanding paragraph (B)(8) of this rule, the physician may provide off-site supervision when the light based medical device is applied for the purpose of hair removal to an established patient if the person to whom the delegation is made pursuant to paragraph (B) of this rule is a cosmetic therapist who meets all of the following criteria:

(1) The cosmetic therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the delegating physician;

(2) The course consisted of at least fifty hours of training, at least thirty hours of which was clinical experience; and

(3) The cosmetic therapist has worked under the on-site supervision of the physician making the delegation a sufficient period of time that the physician is satisfied that the cosmetic therapist is capable of competently performing the service with off-site supervision.

The cosmetic therapist shall maintain documentation of the successful completion of the required training.

(D) The cosmetic therapist, physician assistant, registered nurse or licensed practical nurse shall immediately report to the supervising physician any clinically

Exhibit 1 8 *** DRAFT - NOT YET FILED *** 4731-18-03 5

significant side effect following the application of the light based medical device or any failure of the treatment to progress as was expected at the time the delegation was made. The physician shall see and personally evaluate the patient who has experienced the clinically significant side effect or whose treatment is not progressing as expected as soon as practicable.

(F) A violation of division (A)(5) or (B)(5) of this rule shall constitute "violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board," as that clause is used in division (B)(20) of section 4731.22 of the Revised Code, to wit: section 4731.41 of the Revised Code.

(G) A violation of paragraph (C) or (D) of this rule by a cosmetic therapist shall constitute the unauthorized practice of medicine pursuant to section 4731.41 of the Revised Code.

(H) A violation of paragraph (D) of this rule by a physician assistant shall constitute “a departure from, or failure to conform to, minimal standards of care of similar physician assistants under the same or similar circumstances, regardless of whether actual injury to patient is established," as that clause is used in division (B)(19) of section 4730.25 of the Revised Code.

Exhibit 1 9 To Be Rescinded *** DRAFT - NOT YET FILED *** 4731-18-03 Delegation of the use of light based medical devices.

(A) A physician licensed pursuant to Chapter 4731. of the Revised Code may delegate the application of light based medical devices only for the purpose of hair removal and only if all the following conditions are met:

(1) The light based medical device has been specifically approved by the United States food and drug administration for the removal of hair from the human body; and

(2) The use of the light based medical device for the purpose of hair removal is within the physician's normal course of practice and expertise; and

(3) The physician has seen and personally evaluated the patient to determine whether the proposed application of a light based medical device is appropriate; and,

(4) The physician has seen and personally evaluated the patient following the initial application of a light based medical device, but prior to any continuation of treatment in order to determine that the patient responded well to that initial application; and,

(5) The person to whom the delegation is made is one of the following:

(a) A physician assistant registered pursuant to Chapter 4730. of the Revised Code and the physician has a board approved supplemental utilization plan allowing such delegation; or,

(b) A cosmetic therapist licensed pursuant to Chapter 4731. of the Revised Code; or,

(6) The person to whom the delegation is made has received adequate education and training to provide the level of skill and care required; and,

(7) The physician provides on-site supervision at all times the person to whom the delegation is made is applying the light based medical device; and,

(8) The physician supervises no more than two persons pursuant to this rule at the same time.

[ stylesheet: rule.xsl 2.14] print date: 03/12/2021 01:50 PM Exhibit 1 10 *** DRAFT - NOT YET FILED *** 4731-18-03 2

(B) Notwithstanding paragraph (A)(7) of this rule, the physician may provide off-site supervision when the the light based medical device is applied to an established patient if the person to whom the delegation is made pursuant to paragraph (A) of this rule is a cosmetic therapist licensed pursuant to Chapter 4731. of the Revised Code who meets all of the following criteria:

(1) The cosmetic therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the board; and

(2) The course consisted of at least fifty hours of training, at least thirty hours of which was clinical experience; and

The cosmetic therapist shall maintain documentation of the successful completion of the required training.

(C) The cosmetic therapist, physician assistant, registered nurse or licensed practical nurse shall immediately report to the supervising physician any clinically significant side effect following the application of the light based medical device or any failure of the treatment to progress as was expected at the time the delegation was made. The physician shall see and personally evaluate the patient who has experienced the clinically significant side effect or whose treatment is not progressing as expected as soon as practicable.

(D) For purposes of this rule, on-site supervision requires the physical presence of the supervising physician in the same location (i.e., the physician's office suite) as the cosmetic therapist, physician assistant, registered nurse or licensed practical nurse, but does not require his or her presence in the same room.

(E) For purposes of this rule, off-site supervision means that the supervising physician shall be continuously available for direct communication with the cosmetic therapist and must be in a location that under normal conditions is not more than sixty minutes travel time from the cosmetic therapist's location.

(F) A violation of paragraph (A) (B) or (C) of this rule by a physician shall constitute "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury

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to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code. A violation of division (A)(5) of this rule shall constitute "violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board," as that clause is used in division (B)(20) of section 4731.22 of the Revised Code, to wit: section 4731.41 of the Revised Code.

(G) A violation of paragraph (C) of this rule by a cosmetic therapist shall constitute "A departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code. A violation of paragraph (C) of this rule by a physician assistant shall constitute a "departure from, or failure to conform to, minimal standards of care of similar physician assistants under the same or similar circumstances, regardless of whether actual injury to patient is established," as that clause is used in division (B)(19) of section 4730.25 of the Revised Code.

Exhibit 1 12 *** DRAFT - NOT YET FILED *** 4731-18-04 Delegation of phototherapy and photodynamic therapy.

(A) A physician may delegate to any appropriate person the application of light based medical devices cleared or approved by the United States food and drug administration for phototherapy in treatment of hyperbilirubinemia in neonates only if all the following conditions are met:

(1) The use of the light based medical device for this treatment is within the physician’s normal course of practice and expertise.

(2) The delegation and application of light based medical devices for phototherapy for this treatment is performed pursuant to hospital rules, regulations, policies, and protocols.

(B) A physician may delegate the application of a light based medical device that is a phototherapy device that is cleared or approved by the United States food and drug administration for treatment of psoriasis and similar skin diseases only if all the following conditions are met:

(1) The use of the light based medical device for this treatment is within the physician’s normal course of practice and expertise.

(2) The person to whom the delegation is made is one of the following:

(a) A physician assistant licensed under Chapter 4730. of the Revised Code with whom the physician has an effective supervision agreement authorizing the service;

(b) A registered nurse or licensed practical nurse licensed under Chapter 4723. of the Revised Code; or

(c) A certified medical assistant who has successfully completed and documented the completion of basic training on psoriasis and similar skin diseases and clinical training in the administration of the phototherapy device for the specific skin disease being treated; and

(3) For physician assistants, the authorization shall meet the requirements of Section 4730.21 of the Revised Code;

(4) For registered nurses, licensed practical nurses, and certified medical assistants, the physician has seen and evaluated the patient to determine whether the proposed application of phototherapy is appropriate

(5) For registered nurses, licensed practical nurses, and certified medical assistants, the physician provides on-site supervision at all times that the person to whom the delegation is made is applying the phototherapy.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Mar 12, 2021 12:13, (dv: 0] print date: 03/12/2021 01:52 PM Exhibit 1 13 *** DRAFT - NOT YET FILED *** 4731-18-04 2

approved by the United States food and drug administration for photodynamic therapy for dermatologic purposes only if all the following conditions are met:

(1) The use of the light based medical device for this treatment is within the physician’s normal course of practice and expertise.

(2) The person to whom the delegation is made is one of the following:

(a) A physician assistant licensed under Chapter 4730. of the Revised Code with whom the physician has an effective supervision agreement authorizing the service; or,

(b) A registered nurse or licensed practical nurse licensed under Chapter 4723. of the Revised Code;

(3) For physician assistants, the authorization shall meet the requirements of Section 4730.21 of the Revised Code;

(4) For registered nurses and licensed practical nurses, the physician has seen and evaluated the patient to determine whether the proposed application of photodynamic therapy is appropriate;

(5) For registered nurses and licensed practical nurses the person to whom the delegation is made completes basic training on photodynamic therapy and clinical training in the administration of photodynamic therapy for the specific disease or disorder being treated and the completion of this training is documented by the person to whom the delegation is made; and

(6) For registered nurses and licensed practical nurses, the physician provides on-site supervision at all times that the person to whom the delegation is made is applying the photodynamic therapy.

(D) Any person to whom a lawful delegation of phototherapy or photodynamic therapy has been made shall immediately report to the supervising physician any clinically significant side effect following the application of the phototherapy or photodynamic therapy device or any failure of the treatment to progress as was expected at the time the delegation was made. The physician shall see and personally evaluate the patient who has experienced the clinically significant side effect or whose treatment is not progressing as expected as soon as practicable.

(E) A violation of paragraph (A), (B), (C), or (D) of this rule by a physician shall constitute "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code. A violation of division (A)(2), (B)(2), or (C)(2) of this rule shall constitute "violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any

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provisions of this chapter or any rule promulgated by the board," as that clause is used in division (B)(20) of section 4731.22 of the Revised Code, to wit: section 4731.41 of the Revised Code.

(F) A violation of paragraph (D) of this rule by a physician assistant shall constitute "a departure from, or failure to conform to, minimal standards of care of similar physician assistants under the same or similar circumstances, regardless of whether actual injury to patient is established," as that clause is used in division (B)(19) of section 4730.25 of the Revised Code.

Exhibit 1 15 To Be Rescinded *** DRAFT - NOT YET FILED *** 4731-18-04 Delegation of the use of light based medical devices; Exceptions.

(A) A physician authorized pursuant to Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery may delegate to any appropriate person the application of light based medical devices approved by the United States food and drug administration for phototherapy in treatment of hyperbilirubinemia in neonates.

(B) A physician authorized pursuant to Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery may delegate to any appropriate person the application of a light based medical device that is a fluorescent lamp phototherapy device for treatment of psoriasis and similar skin diseases. A flurorscent lamp photohterapy device is a device that emits ultraviolet light through the use of one or more fluorescent bulbs and is approved by the United States food and drug administration for phototherapy in the treatment of psoriasis or similar skin diseases.

[ stylesheet: rule.xsl 2.14, (dv: 0] print date: 03/12/2021 01:52 PM Exhibit 1 16 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board original filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 189936 File Date and Time: 04/09/2021 11:22 AM Confirmation Number: 66271ead212b3cad4f3ccd47cdda4f70 ORIGINAL FILE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4731-18-01 New N Y 06/13/2021 Definitions. 4731-18-02 Rescission Y Y 06/13/2021 Use of light based medical devices. 4731-18-02 New N Y 06/13/2021 Use of light based medical devices. 4731-18-03 Rescission Y Y 06/13/2021 Delegation of the use of light based medical devices. Delegation of the use of light based medical devices for 4731-18-03 New N Y 06/13/2021 specified non-ablative procedures. Delegation of the use of light based medical devices; 4731-18-04 Rescission Y Y 06/13/2021 Exceptions. 4731-18-04 New N Y 06/13/2021 Delegation of phototherapy and photodynamic therapy.

Exhibit 1 Page17 1 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board revise filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 189936 File Date and Time: 04/16/2021 4:59 PM Confirmation Number: 88dbd6d25f025f81057c9df51bdb08e REVISE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4731-18-01 New N Y 06/13/2021 Definitions. 4731-18-02 Rescission Y Y 06/13/2021 Use of light based medical devices. 4731-18-02 New N Y 06/13/2021 Use of light based medical devices. 4731-18-03 Rescission Y Y 06/13/2021 Delegation of the use of light based medical devices. Delegation of the use of light based medical devices for 4731-18-03 New N Y 06/13/2021 specified non-ablative procedures. Delegation of the use of light based medical devices; 4731-18-04 Rescission Y Y 06/13/2021 Exceptions. 4731-18-04 New N Y 06/13/2021 Delegation of phototherapy and photodynamic therapy.

Exhibit 1 Page18 1 *** DRAFT - NOT YET FILED *** 4731-13-01 Representatives; appearances.

(A) As used in this chapter of the Administrative Code:

(1) "Respondent" means a person who is requesting or has requested a hearing as provided in Chapter 119. of the Revised Code.

(2) "Representative of record" means one person designated by each party to be the party's agent for purposes of receipt of service pursuant to this chapter of the Administrative Code.

(3) "Hearing" means the adjudication hearing held pursuant to Chapter 119. of the Revised Code when a hearing is requested by an applicant or licensee for whom the Board has proposed formal action under section 4730.25, 4731.22, 4759.07, 4760.13, 4761.09, 4762.13, 4774.13, or 4778.14 of the Revised Code.

(4) "Summary Suspension" means the pre-hearing suspension of the license under division (G) of section 4730.25, 4731.22, 4759.07, 4760.13, 4761.09, 4762.13, 4774.13, or 4778.14 of the Revised Code.

(B) The respondent may represent himself or herself or may be represented by an attorney or attorneys who shall be admitted to the practice of law in Ohio. Each attorney representing the respondent shall enter his or her appearance in writing. The respondent may authorize his or her attorney or attorneys to represent the respondent in all facets of a hearing before the board.

(C) If the respondent is self represented, he or she shall be deemed the representative of record for purposes of service pursuant to this chapter of the Administrative Code. If the respondent is represented by one attorney, that attorney shall be deemed the representative of record for purposes of service pursuant to this chapter of the Administrative Code. If the respondent is represented by more than one attorney, the respondent shall designate one of those attorneys as the representative of record for purposes of service pursuant to this chapter of the Administrative Code.

(D) Each representative from the office of the attorney general shall enter his or her appearance in writing. The office of the attorney general shall identify one attorney from that office as the representative of record for purposes of service pursuant to this chapter of the Administrative Code.

(E) The respondent shall not be required to appear personally at any hearing provided he or she has not been subpoenaed. If a respondent has not been subpoenaed to appear at hearing, a respondent may present his or her position, arguments or contentions

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in writing.

(F) An attorney who has filed notice of appearance with the board shall withdraw his or her representation of a respondent by filing a written notice of withdrawal with the board. A written notice of withdrawal should include (i) current address and telephone number of respondent, and (ii) an attestation from the attorney that the respondent has been provided copies of all filings and has been specifically notified of all dates and deadlines.

(G) An attorney who has been designated as a respondent's representative of record for purposes of service pursuant to this chapter of the Administrative Code shall remain the representative of record for that party until a representative of that party files a written notice designating another attorney or the respondent as the representative of record.

(H) Except as otherwise provided under Chapter 119. of the Revised Code, communications from the board or its hearing examiner shall be sent to the representative of record for each party.

Ex. 2 2 *** DRAFT - NOT YET FILED *** 4731-13-03 Authority and duties of hearing examiners.

(A) Hearings shall be conducted before hearing examiner pursuant to section 4731.23 of the Revised Code.

(B) All hearings shall be open to the public, but the hearing examiner conducting a hearing may close the hearing to the extent necessary to protect compelling interests and rights or to comply with statutory requirements. In the event the hearing examiner determines to close the hearing, the hearing examiner shall state the reasons in the public record.

(C) The hearing examiner shall conduct hearings in such a manner as to prevent unnecessary delay, maintain order and ensure the development of a clear and adequate record.

(D) The authority of the hearing examiner shall include, but not be limited to, authority to:

(1) Administer oaths and affirmations;

(2) Order issuance of subpoenas and subpoenas duces tecum to require the attendance of witnesses at hearings and depositions in lieu of live testimony and to require the production of evidence for hearings and depositions in lieu of live testimony;

(3) Examine witnesses and direct witnesses to testify;

(4) Make rulings on the admissibility of evidence;

(5) Make rulings on procedural motions, whether such motions are oral or written;

(6) Hold prehearing conferences;

(7) Request briefs before, during or following the hearing;

(8) Prepare entries, proposed findings, proposed orders or reports and recommendations pursuant to rule 4731-13-15 of the Administrative Code;

(9) Make rulings on requests to broadcast, record, televise or photograph the hearing;

(10) Take such other actions as may be necessary to accomplish the purposes of

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paragraph (C) of this rule; and

(11) Determine the order in which any hearing shall proceed.

(E) The authority of the hearing examiner shall not include authority to grant motions for dismissal of charges, or modify, compromise or settle charges or allegations.

(F) The hearing examiner shall have such other powers, duties, and authority as are granted by statutes or rules.

(G) All rulings on evidence and motions and on any other procedural matters shall be subject to review by the board upon presentation of the proposed findings of facts and conclusions of law of the hearing examiner. When such rulings warrant, the board may remand the matter to the attorney hearing examiner.

(H) The hearing examiner may assist the board by reviewing the evidence in matters that have been subject to a notice of opportunity for hearing but for which no timely hearing request has been filed. In such matters the hearing examiner may prepare proposed findings and a proposed order for the board's consideration.

(I) Briefs provided under paragraph (D)(7) of this rule shall comply with the requirements set forth in rule 4731-13-07.1 of the Administrative Code.

(J) Upon the motion of a party, or upon the hearing examiner’s own motion, the hearing examiner shall have the authority to conduct hearings by use of a live, real-time video-conferencing system. Such a system must provide a means, through the use of software that is widely accessible to the general public without charge, for the hearing examiner, attorneys, the respondent, witnesses, and a court reporter, along with any other necessary participants, to see and converse with each other and to display documentary and physical evidence. Further, the video-conferencing system must also provide a means by which members of the public may view and listen to the hearing.

Ex. 2 4 *** DRAFT - NOT YET FILED *** 4731-13-06 Continuance of hearing.

(A) Except in matters of summary suspension, the board or the board through its hearing examiner, shall continue the initially scheduled hearing upon its own motion in order to more efficiently and effectively conduct its business unless the circumstances establish that a continuance would not serve the interest of justice. The new hearing date shall be set according to the case management schedule approved by the board for the type of violation alleged and available from the board's webistewebsite at http://med.ohio.gov/. In setting the new hearing date, the hearing examiner shall make a reasonable attempt to obtain input from the parties. Upon motion of at least one of the parties demonstrating extraordinary circumstances, the hearing examiner may approve a special case management schedule.

(B) A hearing shall be continued only with the approval of the board or its hearing examiner based upon a written motion of a party or upon the initiative of the hearing examiner.

(1) Before granting any continuance, consideration shall be given to harm to the public which may result from delay in proceedings.

(2) In no event will a motion for a continuance requested less than fourteen days prior to the scheduled date of the hearing be granted unless it is demonstrated that good cause exists which would justify the granting of a continuance.

(D) No continuance of a hearing for a summary suspension shall be granted without the written agreement of the respondent or the respondent's attorney or attorneys and of the board through its secretary and supervising member.

(E) If a continuance is granted, the entry granting the continuance shall specify the dates to which the hearing is continued and shall be set in accordance with the case management schedule. Upon motion of at least one of the parties demonstrating extraordinary circumstances, the hearing examiner may approve a special case management schedule.

(F) Hearings shall not be continued due to the unavailability of a subpoenaed witness without approval of the hearing examiner.

(1) The hearing examiner may hold the record open to accept a deposition in lieu of live testimony of a subpoenaed witness.

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(2) The procedures set forth in rules 4731-13-20 and 4731-13-20.1 of the Administrative Code shall apply to any deposition in lieu of live testimony taken pursuant to this rule.

Ex. 2 6 *** DRAFT - NOT YET FILED *** 4731-13-07.1 Form and page limitations for briefs and memoranda.

(A) All hearing briefs provided under paragraph (D)(7) of rule 4731-13-03 of the Administrative Code and memoranda filed under rule 4731-13-07 of the Administrative Code shall be provided or filed subject to the following requirements:

(1) The body text of a brief or memorandum shall be set in a legible typeface of at least twelve points, either single-spaced or double-spaced.

(2) A brief or memorandum shall not exceed fifteen pages exclusive of the certificate of service and the appendix unless an exception is granted in advance pursuant to paragraph (A)(3) of this rule.

(3) Upon motion by either party, or upon the inititativeinitiative of the hearing examiner, the hearing examiner may authorize briefs or memoranda that exceed fifteen pages, up to a maximum of thirty pages exclusive of the certificate of service and the appendix, in matters that involve complex legal issues. Unless made upon the record at hearing, a motion for such a determination shall be filed no later than seven days prior to the deadline for filing the brief or memorandum.

(4) If a reply memorandum is authorized pursuant to paragraph (C) of rule 4731-13-07 of the Administrative Code, that memorandum shall not exceed seven pages exclusive of the certificate of service and the appendix.

(B) Briefs and memoranda provided in contravention of the requirements set forth in paragraph (A) of this rule will be accepted for filing, however, pages beyond the fifteen page limit shall not be considered. Memoranda filed in contravention of the requirements set forth in paragraph (A) of this rule will be accepted for filing.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Jun 2, 2020 11:58, (dv: 0] print date: 06/02/2020 11:58 AM Ex. 2 7 *** DRAFT - NOT YET FILED *** 4731-13-07 Motions.

(A) Except as otherwise provided under Chapter 4731-13 of the Administrative Code or Chapter 119. of the Revised Code, all motions, unless made upon the record at hearing, shall be made in writing. A written motion shall state with particularity the relief or order sought, shall be accompanied by a memorandum setting forth the grounds therefore, and shall be filed in compliance with rule 4731-13-08 of the Administrative Code. Except in cases of summary suspensions pursuant to division (G) of section 4731.22 of the Revised Code, all prehearing motions except motions for continuance pursuant to rule 4731-13-06 of the Administrative Code and motions to quash pursuant to paragraph (F) of rule 4731-13-13 of the Administrative Code, shall be made no later than fourteen days before the date of hearing unless express exception is granted by the hearing examiner or by this chapter.

(1) If filed by email, motions and supporting or opposing memoranda shall be filed as pdf attachments to emails, and not be incorporated into the body of the email itself.

(2) All supporting or opposing memoranda shall comply with rule 4731-13-07.1 of the Administrative Code.

(B) All motions, together with any supporting documentation, shall be served as provided in rule 4731-13-09 of the Administrative Code.

(C) Any response to a prehearing motion shall be filed within ten days after service of that motion, or at such other time as is fixed by the hearing examiner. A movant may reply to a response only with the permission of the hearing examiner.

(D) Before ruling upon a written motion, the hearing examiner shall consider all memoranda and supporting documents filed. The hearing examiner shall enter a written ruling and shall issue copies to each representative of record. The ruling on all motions made at hearing shall be included in the hearing transcript except where the hearing examiner elects to take the motion under advisement and issue a written ruling at a later time. The hearing examiner shall include in each written ruling on a motion a statement of the reasons therefore.

(E) Except as otherwise provided in this chapter or Chapter 119. of the Revised Code, rulings on all motions filed subsequent to the issuance of the report and recommendation shall be rendered by the board or, if the board is not in session, by its president or the vice president if the president is unavailable acting on its behalf.

(1) Responses to motions shall be filed no later than three days after service of the motion as set forth in the certificate of service attached to the served copy of

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the motion. A movant may reply to a response only with the permission of the board through its president or vice president if the president is unavailable, and only under extraordinary circumstances, such as an assertion that a material inaccuracy of fact or law was provided in the response.

(2) Motions for extension of time for filing objections shall be filed on or prior to the deadline for filing the objections. A motion for extension of time for filing objections filed after the deadline will not be considered absent extraordinary circumstances, as determined by the board through its president or vice president if the president is unavailable.

Ex. 2 9 *** DRAFT - NOT YET FILED *** 4731-13-08 Filing.

(A) A document is "filed" when it is received and time stamped in the offices of the board. For documents received via e-mail or through any electronic filing system implemented by the board, the time stamp provided by the board's computer shall be the time of receipt. Documents received after five p.m. eastern standard time shall not be considered for filing until the next business day.

(B) An original of any document required to be served by Chapter 4731-13 of the Administrative Code shall be filed with the board not more than three days after service.

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To be considered by the board and its hearing examiner, any document required by Chapter 4731-13 of the Administrative Code to be served shall:

(A) Be served either personally, by regular mail, by facsimile, or by e-mail, or through any electronic filing system which provides automatic notice to parties utilized by the board. Service is complete on the date of mailing, e-mailing, facsimile or personal service of the document.

(B) Contain the name, address, and telephone number of the person submitting the document and shall be appropriately captioned to indicate the name of the respondent.

(1) The date of service;

(2) The method by which service was made;

(3) The address where service was made; and

(4) The name of the person or authority who was served.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Jun 2, 2020 12:03, (dv: 0] print date: 06/02/2020 12:03 PM Ex. 2 11 *** DRAFT - NOT YET FILED *** 4731-13-13 Subpoenas for purposes of hearing.

(A) Upon written request, the board shall issue subpoenas for purposes of hearing to compel the attendance and testimony of witnesses and production of books, records and papers. Each subpoena shall indicate on whose behalf the witness is required to testify. Copies of such subpoenas shall be issued to each representative of record.

(B) For purposes of a hearing conducted pursuant to Chapter 119. of the Revised Code, subpoena requests shall specify the name and address of the individual to be served and the date and time at which the individual is to appear. With respect to the production of books, records and papers, such request shall set a compliance date in accordance with the exchange deadlines established by the hearing examiner in rule 4731-13-18.may not specify a date of compliance less than fourteen days prior to hearing.

(C) Except upon leave of the board or its hearing examiner, subpoena requests are to be filed with the board as provided in rule 4731-13-08 of the Administrative Code at least twenty-one days in advance of the requested date of compliance in order to allow sufficient time for preparation and service of the subpoenas.

(D) In the event that the number of subpoenas requested appears to be unreasonable, the board or its hearing examiner may require a showing of necessity therefore and, in the absence of such showing, may limit the number of subpoenas. Absent such a limitation, subpoenas shall be issued within seven days of request. Failure to issue subpoenas within this time may constitute sufficient grounds for the granting of a continuance.

(E) After the hearing has commenced the hearing examiner may order the issuance of subpoenas for purposes of hearing to compel the attendance and testimony of witnesses and production of books, records and papers. Copies of such subpoenas shall be issued to each representative of record.

(F) Upon motion and for good cause, the hearing examiner may order any subpoena be quashed. Motions to quash shall be made in the manner provided in rules 4731-13-07 and 4731-13-08 of the Administrative Code, except that motions to quash shall be filed at least seven days prior to the date of compliance. The non-moving party may file a response no later than five days after service of the motion to quash or at least one day prior to the date of compliance whichever is earlier. Unless a motion to quash has been granted, a witness shall attend the hearing to which he or she was subpoenaed. The board shall make a reasonable attempt to contact any witness whose subpoena has been quashed.

(G) Witnesses shall not be subpoenaed to prehearing conferences.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Jun 2, 2020 12:09, (dv: 0] print date: 06/02/2020 12:09 PM Ex. 2 12 *** DRAFT - NOT YET FILED *** 4731-13-15 Reports and recommendations.

(A) Within thirty days following the close of a hearing conducted under Chapter 119. of the Revised Code, the hearing examiner shall submit a written report setting forth proposed findings of fact and conclusions of law and a recommendation of the action to be taken by the board. The hearing shall not be considered closed until such time as the record is complete, as determined by the hearing examiner.

(B) A copy of such written report shall be issued to each representative of record. The copy issued to the respondent's representative of record shall be accompanied by notice of the date the report and recommendation is to be considered by the board.

(C) Either representative of record may, within ten days of receipt of the hearing examiner's report and recommendation, file written objections to the report and recommendation. Only those objections filed in a timely manner shall be considered by the board before approving, modifying, or disapproving the hearing examiner's recommendation, unless otherwise determined by the board.

(D) Upon written request, the board may grant extensions of the time within which to file objections to the report and recommendation. In the event that the board is not in session, the president of the board may grant such extensions.

(E) Unless otherwise determined by the board based upon written motion of a party, the board shall consider the hearing examiner's report and recommendation and any objections thereto at its next regularly scheduled meeting after the time for filing objections has passed. At that time, the board may do any or all of the following: order additional testimony to be taken: permit the introduction of further documentary evidence; or act upon the report and recommendation. For purposes of taking such additional testimony or documentary evidence, the board may remand to the hearing examiner.

(F) Any motion to reopen the hearing record for purposes of introducing newly discovered material evidence that with reasonable diligence, could not have been discovered and produced at the hearing shall be filed in the manner provided in rules 4731-13-07 and 4731-13-08 of the Administrative Code. Such motion to reopen shall be filed not later than fourteen days prior to the scheduled consideration by the board of the hearing examiner's report and recommendation, unless the newly discovered material evidence, with reasonable diligence, could not have been discovered earlier than fourteen days prior to the scheduled consideration by the board. The other party shall have an opportunity to file, not later than seven days prior to the scheduled consideration by the board of the hearing examiner's report and recommendation, a memorandum contra to said motion.

Any submission of documentation or evidence received by the board after the close of the record and prior to the date of consideration of the hearing examiner's report

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and recommendation by the board shall be deemed a motion to reopen the record pursuant to this rule. If such motion is filed prior to the issuance of the hearing examiner's report and recommendation, the hearing examiner shall rule on the motion. If such motion is filed subsequent to the issuance of the hearing examiner's report and recommendation, the board shall rule on the motion. All submitted materials must be accompanied by an affidavit from the moving party that sets forth how the evidence is material, how the evidence is newly discovered, and why it could not have been produced at hearing. The affidavit must also show that the party made a reasonably diligent effort to obtain the material prior to hearing. Failure to comply with the requirements of this rule shall result in the exclusion of the submitted material unless the moving party shows good cause and the board votes to admit the document or evidence.

(G) Without leave of the board, no party shall be permitted to address the board at the time of consideration of the hearing examiner's report and recommendation. Any request for such leave shall be filed by motion no less than fiveseven days prior to the date the report and recommendation is to be considered by the board. No such leave shall be granted unless the opposing representative of record has been actually notified of the request, unless otherwise determined by the board.

(H) If a request to address the board is granted, the opposing party may also address the board.

Ex. 2 14 *** DRAFT - NOT YET FILED *** 4731-13-16 Reinstatement or restoration of certificate.

Any disciplinary action taken by the board which results in a suspension from practice shall either lapse by its own terms or contain a written statement of the conditions under which the certificate may be reinstated or restored, unless terms for reinstatement or restoration are otherwise governed by statute.

Such conditions may include but are not limited to:

(A) Submission of a written application for reinstatement or restoration;

(B) Payment of all appropriate fees, civil penalitiespenalties, and fines as provided in Chapter 4731. of the Revised Code;

(D) Additional education or training;

(E) Reexamination;

(F) Practice limitations;

(G) Participation in counseling programs;

(H) Demonstration that the respondent can resume practice in compliance with acceptable and prevailing standards.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 May 5, 2020 01:46, (dv: 0] print date: 05/05/2020 01:46 PM Ex. 2 15 *** DRAFT - NOT YET FILED *** 4731-13-17 Settlements, dismissals, and voluntary surrenders.

(A) Settlement shall be negotiated on behalf of the board by the secretary and supervising member of the board. Any settlement agreement containing terms not in conformity with the disciplinary guidelines adopted by the board must have the concurrence of the board's president prior to execution.

(B) Any matter which is the subject of a hearing may be settled by the parties. If settlement negotiations continue after the final day of hearing, the parties shall, within ten days of the final day of hearing, jointly present the hearing examiner with written notice specifying a period of time, not to exceed thirty days, during which the record shall be held open for purposes of negotiation.

(1) If the hearing record has closed or closes during the period of time specified in the parties' joint notice, such notice shall toll the hearing examiner's thirty-day time period for issuance of findings of fact and conclusions of law pursuant to section 4731.23 of the Revised Code.

(2) If, at the conclusion of the time period specified by the parties' joint notice, the hearing examiner has not received appropriate written notice that a settlement agreement has been executed, the tolling of the hearing examiner's thirty-day period for issuance of findings of fact and conclusions of law shall cease, no further settlement negotiations shall be undertaken, and no settlement agreement shall be executed in lieu of the filing of a report and recommendation by the hearing examiner and the issuance of a final order by the board.

(C) Before being submitted to the board for ratification, all settlement agreements shall be in writing and shall be signed by the respondent and by the respondent's attorney, if any. Counsel for the board shall sign the settlement agreement as follows:

(1) If the settlement agreement was negotiated prior to the issuance of a notice of opportunity for hearing, an appropriate board staff attorney shall sign the agreement.

(2) If the settlement agreement was negotiated subsequent to the issuance of a notice of opportunity for hearing, an attorney from the office of the attorney general shall sign the agreement.

(D) Signed settlement agreements shall be submitted to the board for ratification.

(E) If the board ratifies a settlement agreement, the secretary and supervising member of the board shall sign the ratified agreement. following shall sign the ratified

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agreement:

(1) The secretary and supervising member of the board shall sign the ratified agreement.

(2) If the settlement agreement was negotiated prior to the issuance of a notice of opportunity for hearing, an appropriate board staff attorney shall sign the ratified agreement.

(3) If the settlement was negotiated subsequent to the issuance of a notice of opportunity for hearing, an attorney from the office of the attorney general shall sign the ratified agreement.

(F) A notice of dismissal may be entered at any time prior to the filing of the report and recommendation. If negotiations continue after the final day of hearing, the procedures in paragraph (B) of this rule shall be followed. A notice of dismissal shall be authorized and signed by the board's secretary and supervising member.

(G) This rule shall neither apply to nor limit the authority granted the board under division (M) of section 4731.22 of the Revised Code with regard to the surrender of a license or certificate or the withdrawal of an application for a license or certificate.

(H) In the event that the board issues an amended notice of opportunity for hearing, the original notice of opportunity for hearing is automatically superseded by the amended notice. To request a hearing pursuant to Chapter 119. of the Revised Code, the respondent must file a new hearing request in response to the amended notice of opportunity for hearing. For purposes of this chapter of the Administrative Code, "amended cite" means a cite in which there has been a substantive alteration to one or more factual allegations or statutory charges, other than correction of a clerical or technical error, that relates to the allegations set forth in the original notice.

Ex. 2 17 *** DRAFT - NOT YET FILED *** 4731-13-33 "Physicians' Desk Reference".

The board or its hearing examiner may utilize the "Physicians' Desk Reference" (PDR) for information regarding the FDA approved labeling for dangerous drugs. The edition(s) of the PDR utilized shall be the edition(s) contemporaneous with the allegations set forth in the notice of opportunity for hearing upon which the hearing is based. The "PDR" is a well-known and readily available text. It may be found at libraries, bookstores or on the internet at www.pdr.net. The board or its hearing examiner may also utilize the US National Library of Medicine at medlineplus.gov.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Jun 2, 2020 01:01, (dv: 0] print date: 06/02/2020 01:01 PM Ex. 2 18 *** DRAFT - NOT YET FILED *** 4731-13-36 Disciplinary actions.

For purposes of Chapters 4730., 4731., 4759., 4760., 4761., 4762., 4774., and 4778. of the Revised Code and Chapters 4730., 4731., 4774., and 4778. of the Administrative Code:

(A) "Permanent revocation" means the permanent loss of a certificate to practice in Ohio and the inability, at any time, to reapply for or hold any certificate to practice in Ohio. An individual whose certificate has been permanently revoked shall forever thereafter be ineligible to hold any certificate to practice, and the board shall not accept from that individual an application for reinstatement or restoration of the certificate or for issuance of any new certificate.

(B) "Revocation" means the loss of a certificate to practice in Ohio. An individual whose certificate has been revoked shall be eligible to submit an application for a new certificate. The application for a new certificate shall be subject to all requirements for certification in effect at the time the application is submitted. In determining whether to grant such an application, the board may consider any violations of Chapters 4730., 4731., 4759., 4760., 4761., 4762., 4774., and 4778. of the Revised Code, whichever is applicable, that were committed by the individual before or after the revocation of the individual's certificate, including those that formed the basis for the revocation. All disciplinary action taken by the board against the revoked certificate shall be made a part of the board's records for any new certificate granted under this rule.

(C) "Suspension" means the temporary loss of a certificate to practice in Ohio. A suspension shall be imposed for either a definite term or an indefinite term.

(1) An order for a definite term of suspension shall specify the time period of the suspension. A certificate which has been suspended for a definite term shall be reinstated at the conclusion of the specified time period.

(2) An order for an indefinite term of suspension shall contain a written statement of the conditions under which the certificate may be reinstated. Such conditions may include, but are not limited to, the following:

(a) A minimum time period of suspension;

(b) Submission of a written application for reinstatement;

(c) Payment of all appropriate fees, civil penalties, and fines as provided in Chapters 4730., 4731., 4759., 4760., 4761., 4762., 4774., and 4778. of the Revised Code;

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(d) Mental or physical examination;

(e) Additional education or training;

(f) Reexamination;

(g) Participation in counseling programs;

(h) Demonstration that the certificate holder can resume practice in compliance with acceptable and prevailing standards;

(i) Satisfactory completion of all terms, conditions or limitations placed upon the certificate holder through a board-approved consent agreement or board order;

(j) Passage of an examination to determine present fitness to resume practice, pursuant to section 4731.222 of the Revised Code; and

(k) Acceptance of conditions of probation or practice limitations.

(D) "Limitation" means to preclude the certificate holder from engaging in a particular conduct or activity, to impose conditions on the manner in which that conduct or activity may be performed, or to require the certificate holder to abide by specific conditions in order to continue practicing medicine. A limitation shall be either temporary or permanent.

(E) "Probation" means a situation whereby the certificate holder shall continue to practice only under conditions specified by the board. Failure of the certificate holder to comply with the conditions of probation may result in further disciplinary action being imposed by the board. The probation period shall be for either a definite or an indefinite term. If probation is for an indefinite term, the board shall establish a minimum probation period and the board shall release the certificate holder from the conditions of probation upon completion of the minimum probation period and upon the board's determination that the purpose of probation has been fulfilled.

(F) "Reprimand" means the certificate holder is formally and publicly reprimanded in writing.

(G) "No Further Action" means that the board finds that a violation occurred but declines to impose any disciplinary sanction. No further action shall be ordered by the board

Ex. 2 20 *** DRAFT - NOT YET FILED *** 4731-13-36 3

under circumstances where the board finds that all necessary remedial measures have been completed by the certificate holder, future monitoring is unnecessary and reprimand is not warranted.

(H) "Dismissal" means that the board finds that no violation occurred.

(I) "Grant of Application for Certificate" means that the board grants an application for a certificate to practice. In matters where disciplinary violations have been alleged against an applicant for a certificate, the grant of an application for certificate may be accompanied by a suspension, limitation, probation, reprimand or no further action.

(J) "Permanent Denial" and "Permanent Refusal to Register or Reinstate" mean the permanent denial of an application for a certificate to practice in Ohio. An individual whose application for a certificate has been permanently denied shall forever thereafter be ineligible to apply to the board for any certificate to practice, and the board shall not accept from that individual an application for issuance of any certificate.

(K) "Denial" and "Refusal to Register to Reinstate" mean the denial of an application for a certificate to practice in Ohio. An individual whose application for a certificate has been denied shall be eligible to submit a new application for a certificate. The new application shall be subject to all requirements for certification in effect at the time the new application is submitted. In determining whether to grant a new application, the board may consider any violations of Chapters 4730., 4731., 4759., 4760., 4761., 4762., 4774., and 4778. of the Revised Code, whichever is applicable, that were committed by the individual before or after the denial of the individual's previous application, including those that formed the basis for the denial.

Ex. 2 21 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board original filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 190003 File Date and Time: 04/12/2021 8:41 AM Confirmation Number: 87e2dfe236a4e787257d54a856de2f32 ORIGINAL FILE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4731-13-01 Amendment Y Y 06/16/2021 Representatives; appearances. 4731-13-03 Amendment Y Y 06/16/2021 Authority and duties of hearing examiners. 4731-13-06 Amendment Y Y 06/16/2021 Continuance of hearing. 4731-13-07 Amendment Y Y 06/16/2021 Motions. 4731-13-07.1 Amendment Y Y 06/16/2021 Form and page limitations for briefs and memoranda. 4731-13-08 Amendment Y Y 06/16/2021 Filing. 4731-13-09 Amendment Y Y 06/16/2021 Service. 4731-13-13 Amendment Y Y 06/16/2021 Subpoenas for purposes of hearing. 4731-13-15 Amendment Y Y 06/16/2021 Reports and recommendations. 4731-13-16 Amendment Y Y 06/16/2021 Reinstatement or restoration of certificate. 4731-13-17 Amendment Y Y 06/16/2021 Settlements, dismissals, and voluntary surrenders. 4731-13-33 Amendment Y Y 06/16/2021 "Physicians' Desk Reference". 4731-13-36 Amendment Y Y 06/16/2021 Disciplinary actions.

Ex. 2 Page22 1 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board revise filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 190003 File Date and Time: 04/16/2021 4:46 PM Confirmation Number: 87d879ad51dad7a9426d9b25dc5e99 REVISE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4731-13-01 Amendment Y Y 06/16/2021 Representatives; appearances. 4731-13-03 Amendment Y Y 06/16/2021 Authority and duties of hearing examiners. 4731-13-06 Amendment Y Y 06/16/2021 Continuance of hearing. 4731-13-07 Amendment Y Y 06/16/2021 Motions. 4731-13-07.1 Amendment Y Y 06/16/2021 Form and page limitations for briefs and memoranda. 4731-13-08 Amendment Y Y 06/16/2021 Filing. 4731-13-09 Amendment Y Y 06/16/2021 Service. 4731-13-13 Amendment Y Y 06/16/2021 Subpoenas for purposes of hearing. 4731-13-15 Amendment Y Y 06/16/2021 Reports and recommendations. 4731-13-16 Amendment Y Y 06/16/2021 Reinstatement or restoration of certificate. 4731-13-17 Amendment Y Y 06/16/2021 Settlements, dismissals, and voluntary surrenders. 4731-13-33 Amendment Y Y 06/16/2021 "Physicians' Desk Reference". 4731-13-36 Amendment Y Y 06/16/2021 Disciplinary actions.

Ex. 2 Page23 1 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board revise filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 190003 File Date and Time: 05/03/2021 9:11 AM Confirmation Number: e7f7dd5b725bfb49215d0e6398048 REVISE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4731-13-16 Amendment Y Y 06/16/2021 Reinstatement or restoration of certificate. 4731-13-36 Amendment Y Y 06/16/2021 Disciplinary actions.

Ex. 2 Page24 1 *** DRAFT - NOT YET FILED *** 4759-4-04 Continuing Education.

(A) An applicant for renewal or restoration of a license shall demonstrate compliance with the continuing education/professional development requirements of this rule.

(B) An applicant for license renewal or restoration shall:

(1) If licensee is a registered dietitian, certify completion of the continuing education required to hold current registration with the commission on dietetic registration, and complete one hour of ethics or laws, rules, and regulations governing the practice of dietetics in the two-year renewal period. These continuing education hours shall be from activities approved by the commission on dietetic registration, academy of nutrition and dietetics, or the Ohio academy of nutrition and dietetics; or

(2) If licensee is not a registered dietitian, certify the completion of thirty hours of continuing education completed during the two-year renewal period. At least one hour in each renewal period shall relate to ethics or laws, rules, and regulations governing the practice of dietetics. These continuing education hours shall be from activities approved by the commission on dietetic registration, academy of nutrition and dietetics, or the Ohio academy of nutrition and dietetics.

In addition for each biennial renewal period, a licensee that is not a registered dietitian shall use and document a learning process for that renewal period that is consistent with the commission on dietetic registration. Specifically, the licensee that is not a registered dietitian shall document the following: self-reflection on competencies and learning needs, development of a learning plan with goals to maintain and improve on existing competencies and/or develop competencies in new areas or areas of learning deficiency; and progress on the learning plan documented through successful completion of activities in the areas specified in the learning plan. This learning plan must be documented and available to the board upon request pursuant to the audit and disciplinary provisions of divisions (E) and (F) of section 4759.06 of the Revised Code.

(C) All licensees are subject to the audit and disciplinary provisions of devisions (E) and (F) of section 4759.06 of the Revised Code for failure to comply with this rule. Licensees are responsible for retaining records of completion of the continuing education hours required.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Apr 5, 2021 02:56, (dv: 0] print date: 04/05/2021 02:57 PM Ex. 3 1 To Be Rescinded *** DRAFT - NOT YET FILED *** 4759-4-04 Continuing education.

(A) Each applicant for renewal or restoration of a license shall demonstrate compliance with the continuing education/professional development requirements of this rule.

(B) Each applicant for license renewal or restoration shall:

(1) Be a registered dietitian; or

(2) If not a registered dietitian, establish a five year continuing education cycle with the board, and adhere to that schedule for meeting requirements consistent with the options offered by "The commission on dietetic registration."

For each five year cycle an individual learning plan shall be submitted and approved by the board and a log of learning activities maintained by the licensee. A copy of the log shall be submitted directly to the state medical board of Ohio postmarked by June thirtieth of the year that the cycle ends, and shall demonstrate successful completion of at least seventy-five continuing professional education units.

(C) Each applicant for renewal or restoration of a license shall report to the board completion of at least one continuing education unit of board approved education in jurisprudence.

Board approved programs in jurisprudence shall include approved programs and activities relating to current laws, rules, and regulations dealing with the practice of dietetics and recent changes that have occurred to those laws, rules, and regulations. A list of approved programs and activities will be posted on the board's web site at the following link: https://med.ohio.gov/.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Aug 12, 2019 03:47, (dv: 0] print date: 11/13/2020 11:42 AM Ex. 3 2 *** DRAFT - NOT YET FILED *** 4759-4-08 Limited permit.

(A) The board may grant a limited permit to a person who has completed the education and preprofessional requirements for licensure upon the following conditions:

(1) The person has filed a completed application for a limited permit and paid the appropriate fee;

(2) The application contains any required statements or transcripts verifying completion of the academic and preprofessional requirements in order to qualify to take the examination for licensure; and

(3) The applicant indicates intent to take the examination for licensure within six months of the issuance of the limited permit.

(B) The permit shall expire if the permit holder fails to take the examination in a timely manner or fails the examination twice.

(D) A limited permit may be renewed once.

(E) A limited permit holder who fails the examination must report the results to the board office immediately.

(1) The first time the limited permit holder fails, the limited permit holder shall practice only under the direct supervision of an Ohio licensed dietitian.

(2) The second time the limited permit holder fails, the limited permit expires immediately.

(F) A limited permit shall not be issued to a person who has failed the examination two or more times.

(1) The licensed dietitian shall document a supervision plan for the limited permit holder to include specific goals and strategies for assuring competent entry level practice. The supervising dietitian shall periodically document the limited permit holder’s progress. Documentation shall include, but is not limited to, dates of conferences, supervisory notes, written evaluations and recommendations. Documentation should be maintained in the licensed dietitian’s records and be available upon request of the board.

(2) Direct supervision means that the licensee providing the supervision needs to be readily available by telecommunication, or in person and the licensee must

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review the work of the supervisee at least every seven days. When reviewing the work of a supervisee, the licensee shall comply with standards for professional responsibility and practice set forth in Chapter 4759-6 of the Administrative Code.

(H) It is the licensed dietitian’s responsibility to supervise the limited permit holder and to adequately document that supervision. Failure to do so shall be considered a violation of the minimal standards of care for the licensed dietitian and may result in discipline of the licensed dietitian by the state medical board.

Ex. 3 4 To Be Rescinded *** DRAFT - NOT YET FILED *** 4759-4-08 Limited permit.

(A) The board may grant a limited permit to a person who has completed the education and preprofessional requirements for licensure upon the following conditions:

(1) The person has filed a completed application for a limited permit and paid the appropriate fee;

(3) The applicant indicates intent to take the examination for licensure within seven months of the issuance of the limited permit.

(B) The permit shall expire if the permit holder fails to take the examination in a timely manner or fails the examination twice.

(C) Limited permits shall expire the following October thirty-first for those issued between April first and September thirtieth and the following April thirtieth for those issued between October first and March thirty-first.

(D) A limited permit may be renewed.

(E) A limited permit holder who fails the examination must report the results to the board office immediately.

(1) The first time the limited permit holder fails, the limited permit holder shall practice only under the direct supervision of an Ohio licensed dietitian as approved by the board.

(2) The second time the limited permit holder fails, the limited permit expires immediately.

(F) A limited permit shall not be issued to a person who has failed the examination two or more times.

(G) The licensed dietitian who provides direct supervision of a person who has failed the examination and holds a limited permit shall provide sufficient guidance and direction to enable the person to perform competently. Direct supervision means that the licensee providing the supervision needs to be readily available by telecommunication, or in person and the licensee must review the work of the

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 Apr 9, 2003, (dv: 0] print date: 04/05/2021 03:10 PM Ex. 3 5 *** DRAFT - NOT YET FILED *** 4759-4-08 2

supervisee at least every fourteen days. When reviewing the work of a supervisee, the licensee shall comply with standards for professional responsibility and practice set forth in Chapter 4759-6 of the Administrative Code.

Ex. 3 6 *** DRAFT - NOT YET FILED *** 4759-6-02 Standards of professional performance.

Every licensee shall comply with the following standards of professional performance in accordance consistent with the June 1, 2018 "Code of Ethics for the Nutrition and Dietetics Profession" adopted by of the Academy of Nutrition and Dietetics": which is available from the website of the state medical board at the following link: https://med.ohio.gov.

(A) Credentials.

(1) The licensee shall accurately present professional qualifications and credentials.

(2) The licensee shall permit use of that licensee's name for the purpose of certifying that dietetic services have been rendered only if the licensee has provided or supervised those services.

(B) Provision of service.

The licensee shall provide professional service based on client expectations and needs. Quality service is provided, facilitated and promoted based on the licensee's knowledge, experience and understanding of client needs and expectations.

(1) The licensee shall avoid discrimination on the basis of factors that are irrelevant to the provision of professional services, including, but not limited to race, creed, sex, age, or handicap.

(2) The licensee shall assure that sufficient information is available to enable a client to establish mutual goals and make informed decisions.

(1) The licensee shall systematically evaluate the quality of service and improve practice based on evaluation results.

(2) Quality practice requires regular performance evaluation and continuous improvement.

(3) The licensee shall adhere to acceptable standards for that licensee's area of practice and be designated to deliver services as approved by their facility. The authority and privilege to practice within the scope shall be consistent with all state and federal laws and rules governing the practice of dietetics.the standards of practice of the "Academy of Nutrition and Dietetics" and other regulatory agencies such as, but not limited to, the "Centers for Medicare and

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Medicaid Services" (CMS) guidelines as published in the Federal Register.

(4) The licensee shall generate, interpret and effectively apply evidence based interventions substantiated by research.

"Evidence based" interventions means the conscientious, explicit judicious use of current best evidence in making decisions about the care of patients and is consistent with the Centre for evidence based medicine definition in "Evidence based medicine; what it is and what it isn't", Sackett, DL et. al. 1996.

(D) Competence and accountability.

(1) The licensee shall assume responsibility and accountability for personal competence in practice and engage in lifelong learning. Competent and accountable practice includes continuous acquisition of knowledge and skill development.

(a) The licensee shall establish performance criteria, compare actual performance with expected performance, document results and take appropriate action.

(b) The licensee shall conduct self-assessment of strengths and weaknesses at regular intervals and develop, implement and evaluate an individual plan for practice based on assessment of client needs, current knowledge, and clinical experience.

(2) The licensee shall maintain knowledge and skills required for continued professional competence. in a manner consistent with the requirements of the Commission on dietetic registration.

(3) The licensee shall recognize the limits of that licensee's qualifications and seek counsel or make referrals as appropriate.

(E) Conflict.

(1) The licensee shall remain free of conflict of interest while fulfilling the objectives aandand maintaining the integrity of the dietetic profession.

(2) The licensee shall advance and promote the profession while maintaining professional judgment, honesty, integrity, loyalty, and trust to colleguescolleagues, clients and the public.

Ex. 3 8 *** DRAFT - NOT YET FILED *** 4759-6-02 3

(F) Endorsement.

The licensee shall promote or endorse products only in a manner that is true and not misleading.

(G) Communication and application of knowledge.

The licensee shall effectively apply knowledge and communicate with others to achieve common goals by effective sharing and application of their unique knowledge and skills in food, human nutrition and management services.

(H) Utilization and management of resources.

The licensee shall use resources effectively and efficiently.

The licensee shall use a systematic approach to identify, monitor, analyze and justify the use of time, money, facilities, staff and other resources while considering safety, effectiveness and cost in planning and delivering interventions.

(I) Approval of a general program of weight control.

A "general program of weight control" as defined in rule 4759-5-06 of the Administrative Code must be approved by either a registered or licensed dietitian or physician licensed in Ohio. For purposes of division (J) of section 4759.10 of the Revised Code, the licensee shall provide written approval of all components of the general program of weight control and assume responsibility for the following:

(1) Guidelines for instruction: Program content and written step-by-step information that the presenter provides to customers to enable them to follow the meal plan and other aspects of a general program of weight control.

(2) Meal plans: General categories or groups of foods and suggested combinations of specific foods. Meal plans shall not be individualized for specific persons, conditions, or disease states.

(3) Handouts: Any information distributed in conjunction with the general program of weight control.

(4) Supplements: Products, including vitamins, minerals, herbs and other substances used as part of, or an enhancement to, a general program of weight control. The use of these products shall be substantiated by current scientific evidence.

Ex. 3 9 *** DRAFT - NOT YET FILED *** 4759-6-02 4

(J) Supervision.

When providing supervision of another for purposes of division (F)(G) of section 4759.06 and divisions (B) and (E) of section 4759.10 of the Revised Code, and rule 4759-5-02 of the Administrative Code, a licensee shall assume responsibility for the supervision in a manner that protects the public.

(K) Compliance.

The licensee shall comply with all laws and regulations concerning the profession, but shall seek to change them if the laws or regulations are inconsistent with the best interest of the public and the profession. The licensee:

(1) Shall accept the obligation to protect society and the profession by upholding the standards of practice and standards of professional performance; and

(2) Shall report alleged violations of the laws, rules and standards to the state medical. board of dietetics.

(L) Interpretation of information and application of research.

(1) The licensee shall present substantiated information and interpret controversial information without personal bias, recognizing that a legitimate difference of opinion may exist.

(2) The licensee shall apply, participate in, or generate applies, participates in, or generates research to enhance practice and to improve safety and quality of dietetic practice and services.

(M) Confidentiality.

The licensee shall maintain information consistent with legal obligations and client confidentiality.

(N) Professional conduct.

(1) The licensee shall conduct all practices with honesty, integrity, and fairness; and

(2) The licensee shall make and fulfill professional commitments in good faith; and

(3) The licensee shall inform the public and colleagues of services by use of factual

Ex. 3 10 *** DRAFT - NOT YET FILED *** 4759-6-02 5

information.

(4) The licensee shall make reasonable efforts to avoid bias in professional evaluation.

(O) A violation of any provision of this rule, as determined by the board, shall constitute “a departure from, or failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established” as that clause is used in division (A)(11) of section 4759.07 of the Revised Code.

Ex. 3 11 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board - Dietetics Licensure original filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 190004 File Date and Time: 04/09/2021 11:43 AM Confirmation Number: 17e953851751811281eefa1b47c695d5 ORIGINAL FILE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4759-4-04 Rescission Y Y 06/13/2021 Continuing education. 4759-4-04 New N Y 06/13/2021 Continuing Education. 4759-4-08 Rescission Y Y 06/13/2021 Limited permit. 4759-4-08 New N Y 06/13/2021 Limited permit. 4759-6-02 Amendment Y Y 06/13/2021 Standards of professional performance.

Ex. 3 Page12 1 The Honorable Frank LaRose Wendy Zhan, Director Larry Wolpert, Director Secretary of State Legislative Service Commission Joint Committee on Agency Rule Review 180 E. Broad St., 16th Floor 77 South High St., 9th Floor 77 South High St., Concourse Level Columbus,OH 43215 Columbus,OH 43215 Columbus,OH 43215

It is hereby confirmed that the State Medical Board - Dietetics Licensure revise filed the following rule(s) pursuant to section 119.03 of the Ohio Revised Code.

Package Number: 190004 File Date and Time: 04/19/2021 8:23 AM Confirmation Number: 402530ffea58127d98b8b86697ae55 REVISE Rule Number Type FYR CSI JE Date Eff Date Next FYR Tagline 4759-4-04 Rescission Y Y 06/13/2021 Continuing education. 4759-4-04 New N Y 06/13/2021 Continuing Education. 4759-4-08 Rescission Y Y 06/13/2021 Limited permit. 4759-4-08 New N Y 06/13/2021 Limited permit. 4759-6-02 Amendment Y Y 06/13/2021 Standards of professional performance.

Ex. 3 Page13 1 ACTION: Original DATE: 04/12/2021 8:41 AM

MEDICAL BOARD NOTICE OF PUBLIC HEARING

The State Medical Board of Ohio, pursuant to Chapter 119, Ohio Revised Code, hereby gives notice that it will conduct a public hearing to consider the adoption of rules.

The public hearing will be conducted on Monday, May 17, 2021 at 1:30 via GoToWebinar. See below for registration information. Oral or written testimony may be presented by any person affected by the proposed actions.

The following rules are proposed:

Light Based Medical Devices Rules 4731-18-01 Definitions Proposed New Rule 4731-18-02 Use of light based medical devices Proposed New Rule 4731-18-02 Use of light based medical devices Proposed to be Rescinded 4731-18-03 Delegation of the use of light based medical devices for specified non-ablative procedures. Proposed New Rule 4731-18-03 Delegation of the use of light based medical devices for specified non-ablative procedures. Proposed to be Rescinded 4731-18-04 Delegation of phototherapy and photodynamic therapy Proposed New Rule 4731-18-04 Delegation of phototherapy and photodynamic therapy Proposed to be Rescinded

Hearing Rules 4731-13-01 Representatives; Appearances Proposed to be Amended 4731-13-03 Authority and duties of hearing examiners Proposed to be Amended 4731-13-06 Continuance of hearing Proposed to be Amended 4731-13-07 Motions Proposed to be Amended 4731-13-07.1 Form and page limitations for briefs and memoranda Proposed to be Amended 4731-13-08 Filing Proposed to be Amended 4731-13-09 Service Proposed to be Amended 4731-13-13 Subpoenas for purposes of hearing Proposed to be Amended 4731-13-15 Reports and recommendations Proposed to be Amended 4731-13-16 Reinstatement or restoration of certificate Proposed to be Amended 4731-13-17 Settlements, dismissals, and voluntary surrenders Proposed to be Amended 4731-13-33 “Physicians’ Desk Reference” Proposed to be Amended 4731-13-36 Disciplinary actions Proposed to be Amended

Dietetics Rules 4759-4-04 Continuing Education Proposed New Rule 4759-4-04 Continuing Education Proposed to be Rescinded 4759-4-08 Limited Permit Proposed New Rule 4759-4-08 Limited Permit Proposed to be Rescinded 4759-6-02 Standards of professional performance Proposed to be Amended

The proposed rules will be available from:

• State Medical Board of Ohio, 30 East Broad Street, 3rd Floor, Columbus, OH 43215

PHN p(190003) pa(334338)Ex. d: (776036) 4 1 print date: 04/16/2021 11:13 AM 2

Medical Board’s website: http://med.ohio.gov under the Laws & Rules tab (click on Public Rules Hearings)

• Register of Ohio website: http://www.registerofohio.state.oh.us/rules/search (Select “4731 State Medical Board” from the drop-down list.)

All interested persons will be given the opportunity to be heard at the public hearing. Those persons who wish to provide oral testimony at the hearing should preregister. (see instructions below) Persons providing oral testimony are encouraged to also submit a copy of the testimony to Judy Rodriguez at the email address below.

All written comments received by the Board before the close of the hearing record will be considered. Written comments may be provided at the public hearing. However, persons interested in providing written comments are encouraged to do so prior to October 22, 2020.

 via e-mail to: [email protected] 

 via mail to: Kimberly Anderson, Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, OH 43215-6127

Registration Instructions

All interested parties may register for the hearing at https://attendee.gotowebinar.com/register/3723675761974385421

Once registered, parties will receive an email with at link that will connect them to the hearing.

Ex. 4 2 ACTION: Revised DATE: 04/16/2021 4:59 PM

MEDICAL BOARD NOTICE OF PUBLIC HEARING

The State Medical Board of Ohio, pursuant to Chapter 119, Ohio Revised Code, hereby gives notice that it will conduct a public hearing to consider the adoption of rules.

The following rules are proposed:

The proposed rules will be available from:

• State Medical Board of Ohio, 30 East Broad Street, 3rd Floor, Columbus, OH 43215

PHN p(189936) pa(334401)Ex. d: (777021) 4 3 print date: 04/19/2021 11:34 AM 2

Medical Board’s website: http://med.ohio.gov under the Laws & Rules tab (click on Public Rules Hearings)

• Register of Ohio website: http://www.registerofohio.state.oh.us/rules/search (Select “4731 State Medical Board” from the drop-down list.)

 via e-mail to: [email protected]

 via mail to: Kimberly Anderson, Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, OH 43215-6127

Registration Instructions

All interested parties may register for the hearing at https://attendee.gotowebinar.com/register/3723675761974385421

Once registered, parties will receive an email with at link that will connect them to the hearing.

Ex. 4 4 ACTION: Revised DATE: 04/19/2021 8:23 AM

MEDICAL BOARD NOTICE OF PUBLIC HEARING

The State Medical Board of Ohio, pursuant to Chapter 119, Ohio Revised Code, hereby gives notice that it will conduct a public hearing to consider the adoption of rules.

The following rules are proposed:

The proposed rules will be available from:

• State Medical Board of Ohio, 30 East Broad Street, 3rd Floor, Columbus, OH 43215

PHN p(190004) pa(334417)Ex. d: (777028) 4 5 print date: 04/19/2021 11:35 AM 2

Medical Board’s website: http://med.ohio.gov under the Laws & Rules tab (click on Public Rules Hearings)

• Register of Ohio website: http://www.registerofohio.state.oh.us/rules/search (Select “4731 State Medical Board” from the drop-down list.)

 via e-mail to: [email protected]

 via mail to: Kimberly Anderson, Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, OH 43215-6127

Registration Instructions

All interested parties may register for the hearing at https://attendee.gotowebinar.com/register/3723675761974385421

Once registered, parties will receive an email with at link that will connect them to the hearing.

Ex. 4 6 From: Rodriguez, Judith To: A DiPasquale; Barry T. Doyle ([email protected]); Bruce B. Whitman ([email protected]); Cameron McNamee ; Damion Clifford; Daniel Zinsmaster ([email protected]); Deborah R. Lydon ([email protected]); Elaine M. Hiatt PhD ; Eric Vinyard; Greg Warren ; James Leo; James McGovern ([email protected]); Jeffrey Jurca ([email protected]); Jennifer Armstrong; Jessica Bechtel; Joe Feltes; John R. Irwin; Judi Hatcher ; Kay Mavko ; Kim Parks ; Lana Mullet ; Levi Tkach; Lori Herf ; M. D. Roland Benton; Mike Mathy OFAMA; R. Kevin Kerns; Socrates Tuch; Stanley B. Dritz ([email protected]); Stefanie Frank; Steven Greer ; Thomas W. Hess ([email protected]); Vicki Jenkins; ([email protected]); Allison Poulios; [email protected]; Ann Spicer; Ann Warner; Belinda Jones ([email protected]); Betsy Houchen; Blair Barnhart-Kinkle ([email protected]); Bryn Hunt; Carolyn Towner; Catherine Olohan Zwissler; Doug Graff ; Elizabeth Collis (E-mail); Eric Plinke ([email protected]); GeoEmershaw; George Dunigan; Greg Fouche; Gregory W. Bee; Holly Fischer; Inez 617 ([email protected]); J Richard Ludgin (E-mail); James Lindon; Jeffrey Fisher; Jennifer Carlson; Joel Selmeier (E-mail); John Booher; Kevin Devaney ; Kevin L. Miller; Larry Wolpert; Laura Tiberi ; Lisa Emrich; Lloyd DePew ; M. D. Eliot Mostow ([email protected]); Matt Donnelly; McGovern Jim ([email protected]); Melissa Guzman; Michael Oros ; Michael R. Moran; OHA - Mary Gallagher ; Paul Bryson; Paul Hilderbrant; rainykgal ; Ricardo del Castillo; Richard Greely; Richard Kasmer ([email protected]); Robert Carson; Rogers Carol ([email protected]); Ronald House (E-mail); Scott P. Sandrock; Sean McGlone ; Sharon Barnes Ph. D. ; State Board of Psychology; Steve Lanier ([email protected]); Teresa Lample; Terry Guzek; Tim Cosgrove (E-mail); Tom Dilling; Victor Goodman; [email protected]; Willa Ebersole; ACADEMY OF MED. OF CINCINNATI (E-mail); ACADEMY OF MEDICINE OF TOLEDO & LUCAS (E-mail); Dayton Academy of Osteopathic Medicine ([email protected]); [email protected]; Lorain Co. Medical Society; MAHONING COUNTY MEDICAL SOCIETY (E-mail); Pam Fairbanks ; PICKAWAY COUNTY MEDICAL SOCIETY (E-mail); Sandusky County Medical Society; Scioto County Medical Society; Stark Medical Society Subject: Public Rules Hearing Date: Monday, April 12, 2021 2:10:00 PM Attachments: image001.png image003.png image004.png Public Hearing notice.pdf Light Based Medical Devices Rules.pdf Hearing Rules.pdf Dietetics Rules.pdf

Please see attached the attached notice for a Rules Hearing on May 17, 2021.

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

Confidentiality Notice: This message is intended for use only by the individual or entity to whom or which it is addressed and may contain information that is privileged, confidential and/or otherwise exempt from disclosure under applicable law. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify me immediately by telephone.

Ex. 5 1 Ex. 5 2 From: Rodriguez, Judith To: Barry T. Doyle ([email protected]); beth collis; Bruce B. Whitman ([email protected]); Damion Clifford ; Deborah R. Lydon ([email protected]); Doug Graff ; Eric Plinke; James Leo; James McGovern ([email protected]); Jeffrey Jurca ([email protected]); Joe Feltes; John R. Irwin; Levi Tkach; R. Kevin Kerns; Stanley B. Dritz ([email protected]); Thomas W. Hess ([email protected]); William Scott Lavelle ([email protected]); Amanda Nelson ; CT Association; Kelly Statzer; Kay Mavko ; Pat McKnight; Reardon, Jill; Wonski, Chelsea; [email protected]; Dave Horning; David Thompson ; Deborah Cole-Sedivy ([email protected]); Jason Baruch ; Jessica Watkins; Jodi Harlow, RN ; Kara Roche ; Kelly Leahy; M. D. Jason Lichten; Michael Cohen ; Michelle Marksberry; Patrick Clark; Sean Johnson ; Tammy Hands ; Vera Smith; Vic Matteucci; Wally Lovejoy; ([email protected]); Amanda Sines; Belinda Jones (bjones@capitol- consulting.net); Dan Hurley ; David Salisbury; Ebersole Willa ([email protected]); Jeff Smith ; Megan Fitzgibbon ; Monica Hueckel ; Rogers Carol ([email protected]); Sean Dunn; Tony Brigano; Allison DeRoberts ; Jennifer Hayhurst ([email protected]); AMTA-Ohio; Ann Spicer ([email protected]); David P. Corey ([email protected]); Janet Shaw; Jill Hostetler; Kelley Long; Matthew Harney); Melissa Wervey Arnold ([email protected]); Mike Mathey; Ohio Association of Physician Assistants ([email protected]); Steve Landerman ; Trimbath John ([email protected]) Subject: FW: Public Rules Hearing Date: Monday, April 12, 2021 2:11:00 PM Attachments: image001.png image003.png image004.png Public Hearing notice.pdf Light Based Medical Devices Rules.pdf Hearing Rules.pdf Dietetics Rules.pdf

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

From: Rodriguez, Judith Sent: Monday, April 12, 2021 2:10 PM To: A DiPasquale ; Barry T. Doyle ([email protected]) ; Bruce B. Whitman ([email protected]) ;

Ex. 5 3 Cameron McNamee ; Damion Clifford ; Daniel Zinsmaster ([email protected]) ; Deborah R. Lydon ([email protected]) ; Elaine M. Hiatt PhD ; Eric Vinyard ; Greg Warren ; James Leo ; James McGovern ([email protected]) ; Jeffrey Jurca ([email protected]) ; Jennifer Armstrong ; Jessica Bechtel ; Joe Feltes ; John R. Irwin ; Judi Hatcher ; Kay Mavko ; Kim Parks ; Lana Mullet ; Levi Tkach ; Lori Herf ; M. D. Roland Benton ; Mike Mathy OFAMA ; R. Kevin Kerns ; Socrates Tuch ; Stanley B. Dritz ([email protected]) ; Stefanie Frank ; Steven Greer ; Thomas W. Hess ([email protected]) ; Vicki Jenkins ; ([email protected]) ; Allison Poulios ; [email protected]; Ann Spicer ; Ann Warner ; Belinda Jones ([email protected]) ; Betsy Houchen ; Blair Barnhart-Kinkle ([email protected]) ; Bryn Hunt ; Carolyn Towner ; Catherine Olohan Zwissler ; Doug Graff ; Elizabeth Collis (E-mail) ; Eric Plinke ([email protected]) ; GeoEmershaw ; George Dunigan ; Greg Fouche ; Gregory W. Bee ; Holly Fischer ; Inez 617 ([email protected]) ; J Richard Ludgin (E-mail) ; James Lindon ; Jeffrey Fisher ; Jennifer Carlson ; Joel Selmeier (E-mail) <'[email protected]'>; John Booher ; Kevin Devaney ; Kevin L. Miller ; Larry Wolpert ; Laura Tiberi ; Lisa Emrich ; Lloyd DePew ; M. D. Eliot Mostow ([email protected]) ; Matt Donnelly ; McGovern Jim ([email protected]) ; Melissa Guzman ; Michael Oros ; Michael R. Moran ; OHA - Mary Gallagher ; Paul Bryson ; Paul Hilderbrant ; rainykgal ; Ricardo del Castillo ; Richard Greely ; Richard Kasmer ([email protected]) ; Robert Carson ; Rogers Carol ([email protected]) ; Ronald House (E-mail) ; Scott P. Sandrock ; Sean McGlone ; Sharon Barnes Ph. D. ; State Board of Psychology ; Steve Lanier ([email protected]) ; Teresa Lample ;

Ex. 5 4 Terry Guzek ; Tim Cosgrove (E-mail) ; Tom Dilling ; Victor Goodman ; [email protected]; Willa Ebersole ; ACADEMY OF MED. OF CINCINNATI (E-mail) ; ACADEMY OF MEDICINE OF TOLEDO & LUCAS (E-mail) ; Dayton Academy of Osteopathic Medicine ([email protected]) ; [email protected]; Lorain Co. Medical Society ; MAHONING COUNTY MEDICAL SOCIETY (E-mail) ; Pam Fairbanks ; PICKAWAY COUNTY MEDICAL SOCIETY (E-mail) ; Sandusky County Medical Society ; Scioto County Medical Society ; Stark Medical Society Subject: Public Rules Hearing

Please see attached the attached notice for a Rules Hearing on May 17, 2021.

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

Ex. 5 5 From: Jason Lichten To: Rodriguez, Judith Subject: Re: Public Rules Hearing Date: Monday, April 12, 2021 3:19:18 PM Attachments: image001.png image003.png image004.png

https://search-prod.lis.state.oh.us/solarapi/v1/general_assembly_133/bills/hb442/EN/06? format=pdf

Doesn’t HB 442 eliminate the ability of cosmetic therapists to do laser hair removal? If so, why does this document still reference CTs being able to do laser hair removal?

Jason Lichten

On Apr 12, 2021, at 2:11 PM, [email protected] wrote:

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

From: Rodriguez, Judith Sent: Monday, April 12, 2021 2:10 PM To: A DiPasquale ; Barry T. Doyle ([email protected])

Exhibit 6 1 ; Bruce B. Whitman ([email protected]) ; Cameron McNamee ; Damion Clifford ; Daniel Zinsmaster ([email protected]) ; Deborah R. Lydon ([email protected]) ; Elaine M. Hiatt PhD ; Eric Vinyard ; Greg Warren ; James Leo ; James McGovern ([email protected]) ; Jeffrey Jurca ([email protected]) ; Jennifer Armstrong ; Jessica Bechtel ; Joe Feltes ; John R. Irwin ; Judi Hatcher ; Kay Mavko ; Kim Parks ; Lana Mullet ; Levi Tkach ; Lori Herf ; M. D. Roland Benton ; Mike Mathy OFAMA ; R. Kevin Kerns ; Socrates Tuch ; Stanley B. Dritz ([email protected]) ; Stefanie Frank ; Steven Greer ; Thomas W. Hess ([email protected]) ; Vicki Jenkins ; ([email protected]) ; Allison Poulios ; [email protected]; Ann Spicer ; Ann Warner ; Belinda Jones ([email protected]) ; Betsy Houchen ; Blair Barnhart-Kinkle ([email protected]) ; Bryn Hunt ; Carolyn Towner ; Catherine Olohan Zwissler ; Doug Graff ; Elizabeth Collis (E-mail) ; Eric Plinke ([email protected]) ; GeoEmershaw ; George Dunigan ; Greg Fouche ; Gregory W. Bee ; Holly Fischer ; Inez 617 ([email protected]) ; J Richard Ludgin (E-mail) ; James Lindon ; Jeffrey Fisher ; Jennifer Carlson ; Joel Selmeier (E-mail) <'[email protected]'>; John Booher ; Kevin Devaney ; Kevin L. Miller ; Larry Wolpert ; Laura Tiberi ; Lisa Emrich ; Lloyd DePew ; M. D. Eliot Mostow ([email protected]) ; Matt Donnelly ; McGovern Jim ([email protected]) ; Melissa Guzman ; Michael Oros ; Michael R. Moran ; OHA - Mary Gallagher ; Paul Bryson ; Paul Hilderbrant ; rainykgal

Exhibit 6 2 ; Ricardo del Castillo ; Richard Greely ; Richard Kasmer ([email protected]) ; Robert Carson ; Rogers Carol ([email protected]) ; Ronald House (E-mail) ; Scott P. Sandrock ; Sean McGlone ; Sharon Barnes Ph. D. ; State Board of Psychology ; Steve Lanier ([email protected]) ; Teresa Lample ; Terry Guzek ; Tim Cosgrove (E-mail) ; Tom Dilling ; Victor Goodman ; [email protected]; Willa Ebersole ; ACADEMY OF MED. OF CINCINNATI (E-mail) ; ACADEMY OF MEDICINE OF TOLEDO & LUCAS (E-mail) ; Dayton Academy of Osteopathic Medicine ([email protected]) ; [email protected]; Lorain Co. Medical Society ; MAHONING COUNTY MEDICAL SOCIETY (E-mail) ; Pam Fairbanks ; PICKAWAY COUNTY MEDICAL SOCIETY (E-mail) ; Sandusky County Medical Society ; Scioto County Medical Society ; Stark Medical Society Subject: Public Rules Hearing

Please see attached the attached notice for a Rules Hearing on May 17, 2021.

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

Exhibit 6 3

CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 4 Rodriguez, Judith

From: Anderson, Kimberly Sent: Monday, April 19, 2021 5:14 PM To: Jessica Watkins Cc: Rodriguez, Judith Subject: RE: Response to Comments Received Regarding Light-Based Medical Device Rules, Chapter 4731-18, OAC

Jessica-

Your concerns regarding the physician evaluating the patient prior to application of the light based medical device and after the initial application were similar to questions raised by the Physician Assistant Policy Committee and considered by the Board at its March 2021 meeting, prior to filing with JCARR. Please see below an explanation of the Board’s response:

On January 8, 2021, the Physician Assistant Policy Committee (“PAPC”) met and some members of the PAPC raised questions regarding Rules 4731-18-03(A)(3), (A)(4), (B)(3) and (B)(4) and 4731-18-04(B)(2) and (C)(2). In 4731-18- 03(A)(3) and (B)(3), the rule requires the physician to see and evaluate the patient in person to determine whether the proposed application of the specific light-based medical device is appropriate. In 4731-18-03(A)(4), the physician must see and evaluate the patient in person following the initial application of the light-based medical device. The PAPC members asked about this requirement and if it could be completed by telemedicine or delegated to the physician assistant. The Medical Board considered these comments at its March 10, 2021 meeting and determined that the initial evaluations in 4731-18-03(A)(3), (A)(4), (B)(3), and (B)(4) were necessary but could be completed via telemedicine. The Medical Board determined that the initial reviews prior to delegating phototherapy and photodynamic therapy in Rule 4731-18-04(B)(2) and (C)(2) could be done via telemedicine and that these reviews were not necessary for physician assistants. The draft rules reflect these amendments.

I hope this answers your question. We will also file your comment with the comments to be considered at the May 17, 2021 public hearing on these rules. You are also welcome to participate. Attached is the link with instructions:

https://med.ohio.gov/LinkClick.aspx?fileticket=inH45NxCasY%3d&portalid=0

Thank you.

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

1 Exhibit 6 5

From: Jessica Watkins Sent: Thursday, April 15, 2021 1:29 PM To: Anderson, Kimberly Subject: Re: Response to Comments Received Regarding Light‐Based Medical Device Rules, Chapter 4731‐18, OAC

Hello Kimberly,

I noticed that the existing proposed rules (now up for hearing on May 17), no longer require specific additional training for physician assistants, but still require significant oversight with the pre and post evaluation requirements by a physician. Your recent correspondence with me stated:

The rule will be amended to address your concerns regarding supervision and training, so that any specific training and supervision requirements are eliminated and instead the rule will refer to the physician assistant statutes with respect to physician supervision, delegation and training.

The pre and post evaluation requirement is still quite cumbersome for PA practice and I was hoping you could clarify if you believe the final rule will refer to existing PA statutes regarding physician supervision, rather than the specific additional supervising requirements (as per 473‐18‐03 (A)3 and (A)4.)

Hope my question is not too confusing!

Thank you kindly, Jessica Watkins, PA-C Medical and Cosmetic Provider O: 513.984.4801

Discover healthy, beautiful skin at monadermatology.com.

On Feb 19, 2021, at 6:55 PM, [email protected] wrote:

2 Exhibit 6 6

Ms. Watkins:

Thank you for the comments received from MONA Dermatology regarding the proposed rules related to light-based medical devices. In the comments, you and your colleagues stated that the physician pre and post procedure evaluation is not necessary for physician assistants due to their current supervisory agreements and the training requirements in the rules, and on-site physician supervision should not be required 100% of the time for physician assistants. You recommended that the physician must be available by phone and within an appropriate distance in case complications arise. Finally, you recommended that vascular laser delegation should be expanded to include other laser types for dermatologic uses.

Your comments were reviewed at the Policy Committee meeting in December 2020 and the Board provides the following response:

Allowing physician assistants to perform non-ablative vascular lasers is an expansion on the current rule. The Board would like to evaluate this prior to including other laser types. The rule will be amended to address your concerns regarding supervision and training, so that any specific training and supervision requirements are eliminated and instead the rule will refer to the physician assistant statutes with respect to physician supervision, delegation and training.

Please let me know if you have additional questions. Thank you.

Kimberly C. Anderson Chief Legal Counsel State Medical Board of Ohio 30 E. Broad Street, 3rd Floor Columbus, Ohio 43215-6127 O: 614-466-7207 C: 614-230-9077 [email protected] Med.ohio.gov

WARNING: CONFIDENTIALITY NOTICE - The information enclosed with this transmission is the private, confidential property of the sender, and the material is privileged communication intended solely for the individual indicated. If you are not the intended recipient, you are notified that any review, disclosure, copying, distribution, or the taking of any other action relevant to the contents of this transmission are strictly prohibited. If you have received this transmission in error, please notify the sender immediately at the contact information above.

3 Exhibit 6 7 From: Anderson, Kimberly To: Jessica Watkins Cc: Rodriguez, Judith Subject: RE: Hearing May 17 Date: Friday, May 14, 2021 1:34:41 PM Attachments: image001.png image003.png image004.png

Ms. Watkins-

We have forwarded this question to the hearing examiner for the rules hearing. It is my understanding that individuals testify in the order that they register and they may register during the hearing. I do not know if Dr. Foad is registered and if so, what number she holds in the order of registration. Our hearing examiner should have that information.

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Jessica Watkins Sent: Friday, May 14, 2021 12:44 PM To: Anderson, Kimberly Subject: Hearing May 17

Hi Kimberly, I just wanted to confirm you had Dr Mona Foad down for commentary at the hearing on Monday. If

Exhibit 6 8 so, are you privy to any details about the order in which she will speak, how many will speak, timing, etc? Thanks!

Jessica Watkins, PA-C Medical and Cosmetic Provider O: 513.984.4801

Discover healthy, beautiful skin at monadermatology.com.

Exhibit 6 9 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Response to Comments Received Regarding Light-Based Medical Device Rules, Chapter 4731-18, OAC Date: Monday, May 17, 2021 8:19:51 AM Attachments: Light base rule changes .pdf image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Jessica Watkins Sent: Saturday, May 15, 2021 4:12 PM To: Anderson, Kimberly ; Rodriguez, Judith Cc: Dr. Mona Foad ; Megan Niese ; Anna Donovan Subject: Re: Response to Comments Received Regarding Light-Based Medical Device Rules, Chapter 4731-18, OAC

Good afternoon,

Please see the attached letter from our practice regarding Chapter 4731-18 OAC in anticipation of

Exhibit 6 10 the public hearing this Monday, May 17.

Sincerely, Jessica Watkins, PA-C

Exhibit 6 11 Attn: Kimberly Anderson

30 East Broad Street, 3rd Floor

Columbus, OH 43215-6127

Dear Members of the Board and other interested parties,

As a practicing board certified dermatologist for over 19 years and having employed PAs, NPs, RNs and LPNs, it is my opinion that PAs and NPs should not require the rule as written in 473-18-03 (A)3 and (A)4. In Ohio and in our practice, PAs and NPs are often the principal care provider for patients in regards to examination, diagnosis, treatment, and execution of those treatments. This is all without direct examination by a physician. This rule significantly decreases the expediency in which we can provide high quality effective care to our patients. For example, a patient may come in to treat a wart. One of the effective options we commonly use to treat warts is a VBeam, which is a pulse dye laser. Since the PA is currently unable to use the laser, the patient must be rescheduled with either an MD or an NP to take over their care. This happens frequently in our office and not only undermines the patients confidence in the PA, but also does not provide the best patient care. Another scenario we commonly see is with our rosacea patients. Aside from prescriptions and topicals, Intense Pulse Light and laser treatment are very popular adjuncts to their care. Since the PA cannot perform these procedures, patients have to transition care to another provider on another day and the same situation as treating warts ensues with lack of patient confidence and inconvenience to the patient.

NP’s and PA’s may have a different education model prior to seeing patients, but they have the same patient care model once they are certified and are often the primary provider of care in a dermatology office. NPs are currently able to use these devices to treat patients without these tedious parameters. PAs should not have a separate set of requirements versus NPs in their scope of practice.

Individuals such as LPNs and cosmetic therapists lack the comprehensive medical training and clinical experience to perform these procedures with little to no oversight and may require rules to the effect of 473-18-03 (A)3 and (A)4. There is no comparison between these roles and PAs should not be placed in the same category as to their oversight. Considering PAs routinely perform procedures that carry far greater risks such as surgical excisions, chest tube placement, central lines and tracheostomies, the need to appoint higher standards of oversight for light based therapies is baseless.

Exhibit 6 12 In summary, PAs are critical providers of care at MONA Dermatology and we are concerned that this rule is not in line with current Ohio legislation pertaining to existing statutes with respect to physician supervision, delegation and training. It would be a mistake to put forth legislation that is overly cumbersome for physicians and PAs in practice.

We are grateful for the opportunity to provide our feedback on an important issue.

Best, Dr. Mona Foad Jessica Watkins, PA-C Megan Niese, PA-C Anna Luning, CNP

Exhibit 6 13 From: Jessica Watkins To: Rodriguez, Judith Cc: Mona Foad Subject: Re: Public Rules Hearing Date: Wednesday, April 14, 2021 12:19:59 PM

Hi, Thank you for providing timely updates on the legislative process. Can you clarify if written commentary will be reviewed at the time of the hearing from those who can not be there in person (myself, my supervising physician for example)?

Jessica Watkins, PA-C Medical and Cosmetic Provider O: 513.984.4801

Exhibit 6 14 From: Jen Johns To: Rodriguez, Judith Subject: Light-Based Medical Procedures Date: Tuesday, April 20, 2021 4:56:02 PM Attachments: image001.png image002.png

Hi Judith:

In our initial review of the proposed rules, we believe there should be evidence of appropriate education, training, and competency to perform them regardless of provider type. Is there any evidence behind the numbers below that they are appropriate for achieving competency in these procedures?

“For a registered nurse or licensed practical nurse and cosmetic therapists, the physician must ensure that the person to whom the delegation is made has received adequate education and training to provide the level of skill and care required including; (a) Eight (8) hours of basic education that must include the following topics: light based procedure physics, tissue interaction in light based procedures, light based procedure safety including use of proper safety equipment, clinical application of light based procedures, pre and post-operative care of light based procedure patients, and reporting of adverse events; (b) Observation of fifteen (15) procedures for each specific type of vascular laser non-ablative procedure delegated. The procedures observed must be performed by a physician for whom the use of this specific vascular laser procedure is within the physician’s normal course of practice and expertise; and (c) Performance of twenty (20) procedures under the direct physical oversight of the physician on each specific type of vascular laser non-ablative procedure delegated. The physician overseeing the performance of these procedures must use this specific vascular laser procedure within the physician’s normal course of practice and expertise; (d) Satisfactory completion of training shall be documented and retained by each physician delegating and the delegate. The education requirement in (a) must only be completed once by the delegate regardless of the number of types of specific vascular laser procedures delegated and the number of delegating physicians. The training requirements in (b) and (c) must be completed by the delegate once for each specific type of vascular laser procedure delegated regardless of the number of delegating physician; (8) For delegation to a registered nurse or licensed practical nurse, the physician provides on-site supervision at all times that the person to whom the delegation is made is applying the vascular laser; and, (9) For delegation to a registered nurse or licensed practical nurse, the physician supervises no more than two persons pursuant to this rule at the same time.”

Thank you, Jen

Jen Johns, MPH Executive Director

Exhibit 6 15 The Academy of Medicine of Cleveland & Northern Ohio (AMCNO) 6111 Oak Tree Blvd. Ste. 150 Independence, Ohio 44131 Mobile: 216-532-4505 Email: [email protected]

Exhibit 6 16 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Rules notice and hearing opportunity Date: Friday, April 23, 2021 4:19:02 PM Attachments: image003.png image004.png Notice and rules 5-17-21.pdf image001.png image003.png image004.png

For rules hearing.

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Scott Cackler Sent: Friday, April 23, 2021 3:51 PM To: Anderson, Kimberly Subject: Fwd: Rules notice and hearing opportunity

Kim, sorry for the delay. Started a new job and things got away from me. This is in follow up of PAPC discussion. My only question about light based code was in 4731-18-03(B)5a to remove "authorizing the service". Those 3 words at the end seems like the SA must reference light based therapy. This is repeated a few other times in the code when referring to SA's. I don't think the intent is to add a list of things can and can't do to the SA but to verify that light based therapy is something you and your supervising physician are comfortable with the PA performing under their SA but not actually listing

Exhibit 6 17 it on the SA.

------Forwarded message ------From: [email protected] Date: Fri, Apr 23, 2021 at 11:50 AM Subject: Rules notice and hearing opportunity To:

Good morning! Just as an FYI, I am sending you the notice for the Board’s rules hearing on 5/17/21. You are always welcome to watch or contribute. As always, please let me know if you have any questions or concerns.

Have a great weekend.

Jill

Jill Phalen Reardon Director of External Affairs State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614 466 0781 c: 614 551 9957 [email protected] w: med.ohio.gov

Exhibit 6 18 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 19 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: 4731-18-1 (clarification of light-based therapy rule) Date: Wednesday, April 28, 2021 4:37:43 PM Attachments: image001.png image003.png image004.png

Comments for the 5-17-21 hearing.

Can you provide the standard response and let her know about the hearing? Thanks.

Kim

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Kelly Statzer Sent: Wednesday, April 28, 2021 4:26 PM To: Anderson, Kimberly Subject: 4731-18-1 (clarification of light-based therapy rule)

Dear Ms. Anderson,

Exhibit 6 20 I am an unlicensed cosmetic therapist. After reading through the SMBO proposal a third time, I am becoming more and more concerned. I feel we need some clarification.

4731-18-03 Delegation of the use of light based medical devices for specified non-ablative procedures, (Physician delegation training)

(7) For cosmetic therapists, registered nurses and licensed practical nurses, the physician shall "ENSURE" the person to whom the delegation is made has received adequate education and training to provide the level of skill and care required including:

Is SMBO requiring us to train with every new physician we work under and with every device (wavelength) we use with them to “ENSURE the person to whom the delegation is made has received adequate education and training.” whether we were licensed previously or are newly licensed?

(7)(a)(b)(c) The requirement of 8 hours of basic education, observation of 15 procedures, and performance of 20 procedures. (It is felt this may be extremely difficult to find a physician that is even willing to do this, not to mention the cost involved in paying a physician to perform and observe 35 treatments, which could be quadrupled considering we can use four different wavelengths for hair removal.)

(7)(d) Satisfactory completion of training shall be documented and retained by EACH physician delegating and the delegate.

(7)(e) Delegates who, prior to the effective date of this rule, have been applying a specific type of light based medical device procedure for hair removal for at least two (2) years through a lawful delegation by a physician, shall be exempted from the education and training requirements of (a), (b), and (c) for that type of procedure provided that they obtain a written certification from one of their current delegating physicians stating that the delegate has received sufficient education and training to competently apply that type of light based medical device procedure. This written certification must be completed no later than sixty (60) days after the effective date of this provision, and a copy of the certification shall be retained by each delegating physician and each delegate.

Will prior licensed cosmetic therapists, working under the delegation of their CURRENT delegating physician for 1-1/2 years, still be required to go through this training?

What if they had been doing laser for the previous 5-20 years working under the delegation of other physicians?

What if they changed jobs or their previous physician decided to retire?

(8) For cosmetic therapists, registered nurses and licensed practical nurses, the

Exhibit 6 21 physician provides on-site supervision at all times that the person to whom the delegation is made is applying the light based medical device; and,

(9) For cosmetic therapists, registered nurses and licensed practical nurses, the physician supervises no more than two persons pursuant to this rule at the same time.

On-site supervision? For how long? This is confusing as it relates to on-site supervision noted below.

(C)(1) The cosmetic therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the delegating physician;

(C)(2) The course consisted of at least fifty hours of training, at least thirty hours of which was clinical experience; and

(C)(3) The cosmetic therapist has worked under the on-site supervision of the physician making the delegation a sufficient period of time that the physician is satisfied that the cosmetic therapist is capable of competently performing the service with off-site supervision.

Off-site supervision? How does this relate to on-site supervision noted above?

4731-18-03 Delegation of the use of light based medical devices (Covers actual educational requirements for laser)

(B)(1) The cosmetic therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the board; and (2) The course consisted of at least fifty hours of

Exhibit 6 22 training, at least thirty hours of which was clinical experience; and

The educational requirements remain the same as they have for 20 years, total of 50 hours (20 didactic and 30 clinical). The financial impact the additional physician training will have on the schools and businesses is extremely concerning.

I noticed that nowhere in this rule is there mention of telemedicine. In light of the recent pandemic and considering Franklin county was recently upgraded again to “purple,” I would have thought that consideration would have been given to the ability to utilize telemedicine to limit unnecessary exposure in the workplace. Is there other language we can refer to with regard to telemedicine?

I appreciate any insight you can give into this new language. Sincerely,

Kelly Ott-Statzer

Exhibit 6 23 To whom it may concern of the Ohio Medical Board:

My name is Stephen Lopez, a plastic surgeon practicing in Canton Ohio, affiliated with Aultman hospital. I have been collaborating with a board-certified physician assistant (PA-C) in my practice for over one year. I am writing in regard to the OAC 4731-18-02 rule, which has put constraints on my practice due to:

• Inhibiting patient access to care for both medically necessary CO2 laser procedures, as well as cosmetic procedures. • We are unable to service patients in a timely manner, secondary to an over burden of the schedule, if I am the only one authorized to perform CO2 laser in our practice. • Practices outside the state of Ohio do not have these constraints and allow advanced practicing providers (APPs) use high wavelength lasers for multiple procedures. • This constraint affects us financially and as previously mentioned, delays in patient care.

Surrounding states that allow APPs to utilize high powered wavelength lasers, such as CO2 laser are all 48 states, except MD and OH. The OAC rule 4731-18-02 is restrictive and does not reflect legislative laws from our neighboring states and has greatly impacted our practice.

In my experience, I have worked with many APPs in othersExhibit states 6 who have operated24 high wavelength lasers for ablative procedures without any increase in complications or issues. I have the utmost confidence that a board-certified PA is qualified to utilize and operate high powered lasers, such as a CO2 laser for ablative procedures.

The changes could have a positive effect on patient access to care, safety, and will ultimately help strengthen practices in Ohio. I hope that we can work together regarding this decision and if I can assist in the process, please let me know.

Sincerely,

Stephen Lopez, MD P: (330)-499-2209 E: [email protected]

Exhibit 6 25

Kimberly Anderson, Chief Legal Counsel May 1, 2021 State Medical Board of Ohio 30 E. Broad Street, 3rd floor Columbus Ohio 43215-6127

The Ohio Academy of Nutrition and Dietetics (OAND) would like to submit the following comments regarding Dietetics rules 4759-4-04 OAC, 4759-4-08 OAC and 4759-6-02 OAC currently proposed by the State Medical Board of Ohio (SMBO).

4759-4-04 Continuing education. OAND supports the new rule as currently proposed.

4759-4-08 Limited Permit. OAND supports the new rule as currently proposed.

4759-6-02 Standards of Professional Performance.

OAND supports the amendments as currently proposed for this rule.

OAND wishes to recognize and thank Nathan Smith and Jill Reardon for working with us during the rule process and responding to our previous concerns.

Sincerely, Kay Mavko, MS, RDN, LD State Regulatory Specialist Ohio Academy of Nutrition and Dietetics

Patricia McKnight, MS, RDN, LD State Policy Representative Ohio Academy of Nutrition and Dietetics

Exhibit 6 26

Exhibit 6 27 From: [email protected] To: Rodriguez, Judith Subject: RE: Public Rules Hearing Date: Monday, April 12, 2021 6:46:22 PM Attachments: image001.png image003.png image004.png

Judith,

FYI ….. I believe there is an error in the public notice that I received today for the upcoming May 17 Public Rules Hearing. On page two in the paragraph about written comments it states that “ However, persons interested in providing written comments are encouraged to do so prior to October 22,2020.” Obviously that date has passed.

I hope this catch is helpful.

Kay Mavko, MR, RDN, LD State Regulatory Specialist Ohio Academy of Nutrition and Dietetics

From: [email protected] Sent: Monday, April 12, 2021 2:11 PM To: Barry T. Doyle ([email protected]) ; beth collis ; Bruce B. Whitman ([email protected]) ; Damion Clifford ; Deborah R. Lydon ([email protected]) ; Doug Graff ; Eric Plinke ; James Leo ; James McGovern ([email protected]) ; Jeffrey Jurca ([email protected]) ; Joe Feltes ; John R. Irwin ; [email protected]; R. Kevin Kerns ; Stanley B. Dritz ([email protected]) ; Thomas W. Hess ([email protected]) ; William Scott Lavelle ([email protected]) ; Amanda Nelson ; CT Association ; Kelly Statzer ; Kay Mavko ; Pat McKnight ; [email protected]; [email protected]; [email protected]; Dave Horning ; David Thompson ; Deborah Cole-Sedivy ([email protected]) ; Jason Baruch ; Jessica Watkins ; Jodi Harlow, RN ; Kara Roche ; Kelly Leahy ; M. D. Jason Lichten ; Michael Cohen ; Michelle Marksberry ; Patrick Clark ; Sean Johnson ; Tammy Hands ; Vera Smith ; Vic Matteucci ; Wally Lovejoy ; ([email protected]) ; Amanda Sines ; Belinda Jones ([email protected])

Exhibit 6 28 ; Dan Hurley ; David Salisbury ; Ebersole Willa ([email protected]) ; Jeff Smith ; Megan Fitzgibbon ; Monica Hueckel ; Rogers Carol ([email protected]) ; Sean Dunn ; Tony Brigano ; Allison DeRoberts ; Jennifer Hayhurst ([email protected]) ; AMTA- Ohio ; Ann Spicer ([email protected]) ; David P. Corey ([email protected]) ; Janet Shaw ; Jill Hostetler ; Kelley Long ; Matthew Harney) ; Melissa Wervey Arnold ([email protected]) ; Mike Mathey ; Ohio Association of Physician Assistants ([email protected]) ; Steve Landerman ; Trimbath John ([email protected]) Subject: FW: Public Rules Hearing

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

From: Rodriguez, Judith Sent: Monday, April 12, 2021 2:10 PM To: A DiPasquale ; Barry T. Doyle ([email protected]) ; Bruce B. Whitman ([email protected]) ; Cameron McNamee ; Damion Clifford ; Daniel Zinsmaster ([email protected])

Exhibit 6 29 ; Deborah R. Lydon ([email protected]) ; Elaine M. Hiatt PhD ; Eric Vinyard ; Greg Warren ; James Leo ; James McGovern ([email protected]) ; Jeffrey Jurca ([email protected]) ; Jennifer Armstrong ; Jessica Bechtel ; Joe Feltes ; John R. Irwin ; Judi Hatcher ; Kay Mavko ; Kim Parks ; Lana Mullet ; Levi Tkach ; Lori Herf ; M. D. Roland Benton ; Mike Mathy OFAMA ; R. Kevin Kerns ; Socrates Tuch ; Stanley B. Dritz ([email protected]) ; Stefanie Frank ; Steven Greer ; Thomas W. Hess ([email protected]) ; Vicki Jenkins ; ([email protected]) ; Allison Poulios ; [email protected]; Ann Spicer ; Ann Warner ; Belinda Jones ([email protected]) ; Betsy Houchen ; Blair Barnhart-Kinkle ([email protected]) ; Bryn Hunt ; Carolyn Towner ; Catherine Olohan Zwissler ; Doug Graff ; Elizabeth Collis (E-mail) ; Eric Plinke ([email protected]) ; GeoEmershaw ; George Dunigan ; Greg Fouche ; Gregory W. Bee ; Holly Fischer ; Inez 617 ([email protected]) ; J Richard Ludgin (E-mail) ; James Lindon ; Jeffrey Fisher ; Jennifer Carlson ; Joel Selmeier (E-mail) <'[email protected]'>; John Booher ; Kevin Devaney ; Kevin L. Miller ; Larry Wolpert ; Laura Tiberi ; Lisa Emrich ; Lloyd DePew ; M. D. Eliot Mostow ([email protected]) ; Matt Donnelly ; McGovern Jim ([email protected]) ; Melissa Guzman ; Michael Oros ; Michael R. Moran ; OHA - Mary Gallagher ; Paul Bryson ; Paul Hilderbrant ; rainykgal ; Ricardo del Castillo ; Richard Greely ; Richard Kasmer ([email protected]) ; Robert Carson ; Rogers Carol ([email protected]) ; Ronald House (E-mail) ; Scott P. Sandrock ; Sean McGlone ; Sharon Barnes Ph. D. ; State Board of Psychology ; Steve Lanier ([email protected]) ; Teresa Lample ; Terry Guzek ; Tim Cosgrove (E-mail) ; Tom Dilling ; Victor Goodman ;

Exhibit 6 30 [email protected]; Willa Ebersole ; ACADEMY OF MED. OF CINCINNATI (E-mail) ; ACADEMY OF MEDICINE OF TOLEDO & LUCAS (E-mail) ; Dayton Academy of Osteopathic Medicine ([email protected]) ; [email protected]; Lorain Co. Medical Society ; MAHONING COUNTY MEDICAL SOCIETY (E-mail) ; Pam Fairbanks ; PICKAWAY COUNTY MEDICAL SOCIETY (E-mail) ; Sandusky County Medical Society ; Scioto County Medical Society ; Stark Medical Society Subject: Public Rules Hearing

Please see attached the attached notice for a Rules Hearing on May 17, 2021.

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

Exhibit 6 31 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: HB 442 Impact Statement Date: Wednesday, May 12, 2021 4:26:13 PM Attachments: HB 442 IMPACT STATEMENT.docx image001.png image003.png image004.png

For 5.17.21 hearing

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Kristy Good-Bath Sent: Wednesday, May 12, 2021 4:14 PM To: Anderson, Kimberly Cc: vickie aboutface-ctc.com ; Kelly Statzer ; Sweterlitsch, Martha ; Winder, Rachel G. Subject: HB 442 Impact Statement

Hello Kimberly,

I wish to provide the attached impact statement for consideration during the May 17 discussion of HB 442, please.

Exhibit 6 32

Thank you!

-- Kristy Bath

Exhibit 6 33

IMPACT STATEMENT

My name is Kristine Good-Bath, and I have owned Bella Cosmedica, a medspa in Pickerington, since 2009.

In October of 2019, I started classes with Vickie Mickey at her Cosmetic Therapy Training Center here in Columbus. I opted to make this investment of time away from my family and my business so that I could become licensed as a Cosmetic Therapist. Ultimately, my plan was to re-coup my $18,000 investment and expand my business’s service offerings by providing electrology and laser hair removal services.

My schooling was interrupted by the pandemic, delaying completion by four months. Immediately upon graduation in October of 2020, I successfully completed the Society for Clinical & Medical Hair Removal exam, background check and licensing application and paid all the associated fees. I purchased the necessary equipment and supplies to begin offering hair removal services, located a physician willing to provide oversight for laser treatments and paid an attorney to draft our mutual benefit agreement.

Soon after, I learned of the passage of House Bill 442 which has dealt a severe blow both personally and professionally. The time I have invested in my training is forever gone. My significant financial investment is not likely to be recovered for years, if at all, which only amplifies the pain my business has already endured due to COVID. Clients who were eager to receive treatment now must be referred elsewhere.

A small, but devoted group of us has worked hard and invested even MORE time and money to draft a viable alternative to the language of HB 442. We believe our proposal satisfies a number of concerns from all parties involved. Instead of forcing women out of work and taking away our profession, our approach will serve to grow the field of Cosmetic Therapy, which we understand to have been the original intent of HB 442.

We ask that you please take the necessary time to consider fully and thoughtfully what we are proposing. Please show some mercy and empathy for this often-misunderstood group of mostly women business owners who have already endured so much suffering.

Respectfully,

Kristine Good-Bath Owner, Bella Cosmedica

Exhibit 6 34 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: [email protected] Date: Thursday, May 13, 2021 12:58:51 PM Attachments: image001.png image003.png image004.png

Comment for the rules hearing

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Anna Donovan Sent: Thursday, May 13, 2021 11:40 AM To: Anderson, Kimberly Subject: [email protected]

To Whom It May Concern:

Hello, My name is Anna Luning, a Certified Nurse Practitioner in the state of Ohio. I work at MONA Dermatology, in Cincinnati, Ohio.

I am writing this letter to address my concerns regarding the proposed rule for operating light based medical devices involving the role of a Physician Assistant-

Exhibit 6 35 Certified. Specifically, rule 4731-18-03 Delegation of the Use of Light Based Medical Devices for Specified Non-Ablative Procedures line A(3) and A(4).

A(3) The physician has seen and evaluated the patient to determine whether the proposed application of the specific vascular laser is appropriate; A(4) The physician has seen and evaluated the patient following the initial application of the specific vascular laser, but prior to any continuation of treatment in order to determine that the patient responded well to the initial application of the specific vascular laser.

As a physician assistant in our practice, they are acting as the sole provider responsible for patient care. They are able to diagnose, prescribe, and make important decisions regarding patient care with autonomy. The above proposed rule(s) take away from patient care and require too much time, that is already limited, working in conjunction with a Physician. I also feel strongly that as a self-directing and independent practitioner in the medical sense, a Physician Assistant-Certified should be able to practice independently in a cosmetic orientation. For example, Physician Assistants at MONA Dermatology currently excise skin lesions including melanoma and carcinomas yet they are unable to treat a wart with a pulse- dye laser in which complications are minimal post-treatment. There is a clear difference in standard of care that needs to be addressed.

Secondly, I do not think it is appropriate to continue to list the use of, the delegation of, or other rules and/or definitions pertaining to Physician Assistants in combination with Registered Nurses, Licensed Practical Nurses, or cosmetic therapists. Their education, clinical experience and the expectation their roles demand when functioning as a practicing provider should place them in a separate, and higher, category when determining rules involving their position.

As a Certified Nurse Practitioner in our practice, I function with the same role, responsibility and scope of practice as a Physician Assistant medically. However, I am able to operate much more freely cosmetically with the use of light based medical devices. I do not feel it is necessary for someone practicing at the level of a Physician Assistant to have a requirement including evaluation of a supervising physician before and after treatment, when this is not a requirement for other advanced practice providers such as Nurse Practitioners . At a busy practice this is not conducive for good patient care.

Please consider revising or rescinding rule 4731-18-03 lines A3 and A4 so that Physician Assistants can operate light based medical devices independently from a supervising physician.

Thank you, Anna Luning, CNP, FNP-C

Exhibit 6 36 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 37 From: Rodriguez, Judith To: Dr. Mona Foad Subject: RE: Light based hearing may 17th Date: Monday, May 17, 2021 7:26:00 AM

Mona: Use this link to register:

Registration Instructions All interested parties may register for the hearing at https://attendee.gotowebinar.com/register/3723675761974385421 Once registered, parties will receive an email with at link that will connect them to the hearing.

Judy Rodriguez Public Services Manager

State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-4999 w: med.ohio.gov

-----Original Message----- From: Dr. Mona Foad Sent: Sunday, May 16, 2021 11:37 AM To: Rodriguez, Judith Cc: Jessica Watkins Subject: Light based hearing may 17th

Dear Julie,

I never received a way to register for this hearing

Can you forward it to me abs I will do so immediately. I apologize for the last minute request but I believe this is very important

Thank you!

Mona S. Foad -- *WARNING: CONFIDENTIALITY NOTICE - The information enclosed with this transmission is the private, confidential property of the sender, and the material is privileged communication intended solely for the individual indicated. If you are not the intended recipient, you are notified that any review, disclosure, copying, distribution, or

Exhibit 6 38 the taking of any other action relevant to the contents of this transmission are strictly prohibited. If you have received this transmission in error, please notify the sender immediately at the contact information above.*

Exhibit 6 39 From: Jessica Watkins To: Anderson, Kimberly; Rodriguez, Judith Cc: Dr. Mona Foad; Megan Niese; Anna Donovan Subject: Re: Response to Comments Received Regarding Light-Based Medical Device Rules, Chapter 4731-18, OAC Date: Saturday, May 15, 2021 4:12:28 PM Attachments: Light base rule changes .pdf

Good afternoon,

Please see the attached letter from our practice regarding Chapter 4731-18 OAC in anticipation of the public hearing this Monday, May 17.

Sincerely, Jessica Watkins, PA-C

Exhibit 6 40 Attn: Kimberly Anderson

30 East Broad Street, 3rd Floor

Columbus, OH 43215-6127

Dear Members of the Board and other interested parties,

Exhibit 6 41 In summary, PAs are critical providers of care at MONA Dermatology and we are concerned that this rule is not in line with current Ohio legislation pertaining to existing statutes with respect to physician supervision, delegation and training. It would be a mistake to put forth legislation that is overly cumbersome for physicians and PAs in practice.

We are grateful for the opportunity to provide our feedback on an important issue.

Best, Dr. Mona Foad Jessica Watkins, PA-C Megan Niese, PA-C Anna Luning, CNP

Exhibit 6 42 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Light Based Medical Device Rules Date: Monday, May 17, 2021 8:17:58 AM Attachments: CTAO Comments on 4731-18-03 Light Based Medical Devices 2021 (1).pdf image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Kelly Wert Sent: Monday, May 17, 2021 7:58 AM To: Anderson, Kimberly ; Reardon, Jill ; Contact Subject: Light Based Medical Device Rules

I am writing to provide comment to proposed rule 4731-18-03 in regards to delegation of the use of light based medical devices. My name is Kelly Wert, a former licensed Cosmetic Therapist of 16 years. In addition to owning and operating a laser hair removal business with my partner Dr. Brian Luft, M.D. in Gahanna, I have been the legislative liaison and active member of The Cosmetic Therapy Association of Ohio for 13 years. Prior to the Medical Board eliminating the practical exam

Exhibit 6 43 for Cosmetic Therapy, I was employed by the Medical Board as a proctor for the licensing exam for 3 years. As a tenured Cosmetic Therapist, I am thankful that the Medical Board was able to work toward a solution for the delicensing of our profession and has allowed us to operate as close as possible to the way we were structured prior to HB442. I personally support most of the changes made in the proposed rules. Today, I'm writing in hopes that the following amendments be made to the rules as there are barriers that our businesses face with doctor supervision limitations and telepresence/telemedicine. The attached amendments outlined by the Cosmetic Therapy Association of Ohio will assist our profession in expanding our businesses, services and employability.

Of all amendments noted, I would like to add that our personal practice is in need of expansion. We currently have 2 lasers and are in need of a third. The limitation of the 2 persons delegation at a given time will cause my practice to have to hire an additional physician or nurse practitioner, which is cost prohibitive. Our business is structured around the need for Cosmetic Therapists. As such, we are at a standstill trying to service the needs of a growing practice and laser hair removal market. Physicians are able to supervise up to 5 Nurse Practitioners. The restriction here is a huge barrier to the growth and expansion of my practice as well as others trying to succeed in the marketplace.

I have written previously about the expansion of our scope of practice to include other features offered by the equipment cosmetic therapists operate daily. As confirmed by Dr. Bechtel during the December meeting minutes, there is no reason why a cosmetic therapist, with the additional training set forth for registered nurses and our more extensive training requirements already present, should not be included in the vascular and photodynamic therapy delegation. The exclusion of cosmetic therapists in these delegation rules directly affects the cosmetic therapists employment opportunities with dermatologists, plastic surgeons and others that offer these services. Cosmetic Therapists become unmarketable to these physicians that offer both vascular and hair removal laser services due to the exclusion in these rules.

Thank you for your time and attention to the proposed amendments -- Kelly Wert, C.T.

The Laser Loft is located within Yudu Salons @ Creekside in Gahanna. You may book a laser appointment online @ laserloftsalon.com

Yudu Salons 101 Mill Street, Suite 210 Salon No. 6 Gahanna, OH 43230 614-419-4238

Exhibit 6 44 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 45 The Cosmetic Therapy Association of Ohio

May 14, 2021

Kimberly Anderson, Chief Legal Counsel State Medical Board of Ohio

The Cosmetic Therapy Association of Ohio appreciates the opportunity to make statements on the proposed changes to Rule 4731-18 (01-04) regarding the use and delegation of a light based medical device. We are asking that the rules be adjusted according to the table below and that common barriers that our businesses face with doctor supervision limitations and telepresence/telemedicine be addressed to assist our profession in expanding our services and employability in a recovering post-covid economy.

Action Rule Comments Off-site Supervision 4731-18-01 (I) Cosmetic Therapy small businesses have barriers Definition Adjusted when it comes to doctors being within 60 minutes from the location. Our clients often drive further distances than that to receive our services. CT be Added to 4731-18-03 (A) (5) Dr. Bechtel confirmed vascular laser safety in Dec Vascular Delegation 2020 and initiated CT approval for performing it. CT be Added to 4731-18-03 (A) (7) Educational Requirements can align with nursing Education professions as the basic education outlined overlaps Requirements for with our current general training requirements for Vascular Delegation light based medical device delegation. Tele-Presence / 4731-18-03 (B) (3&4) Implement tele-medicine guidelines for laser hair Tele-Medicine to removal for off-site supervision Added and Defined CT be Removed 4731-18-03 (B) (9) Doctor supervision of no more than two CT’s is a from Physician barrier our small businesses face. There are only 185 Supervision in the profession therefore it would be unlikely a Quantity business would have an inappropriate amount of CT’s being supervised by only one physician if we were removed from this part of the rule. Tele-Presence / 4731-18-03 (C) Clients who are a Fitzpatrick scale of I-III who are on Tele-Medicine to no medication or only on birth control are at the Added and Defined least risk of complications from laser hair removal and would be the right population to allow for a virtual review of the patient health history and waving the in-person evaluation of the treatment response for off-site supervision delegation CT be Added to 4731-18-04 (C)(2 & 4-6) Photodynamic therapy can treat conditions our Photodynamic current clientele (young adults, women with PCOS Therapy Delegation or hormone imbalances, older women) also struggle with such as acne and age spots.

Exhibit 6 46 The Cosmetic Therapy Association of Ohio

The majority of cosmetic therapist businesses only have one Medical Director delegating and to require their off-site supervision be within 60 minutes has been a constant cause of conflict. Some of our doctors travel multiple times throughout a year for business trips, vacations, and similar events. Without their oversight client care and treatment plans are disrupted. Also, with their being so few cosmetic therapists, many of our clients travel over sixty minutes to their appointments for us, especially in the rural regions of the state. A solution could be to allow any physician licensed by the state of Ohio to delegate, including via telemedicine where appropriate, to a cosmetic therapist within their general region of the state. When they are traveling they can establish telemedicine supervision when applicable. That will provide flexibility to the 60-minute radius by doubling the area it covers, allowing the development of more business relationships between doctors and cosmetic therapists.

On December 9, 2020 President Dr. Bechtel states that “vascular lasers are probably the safest of all lasers and have a lower risk of scarring, and that is why the vascular laser was chosen for expansion into the scope of practice of…cosmetic therapists.” He also mentions this was patient safety focused and includes rigorous educational requirements, including 8 hours of classroom education. Most cosmetic therapists do the full 50 hours of laser training to qualify for off-site supervision for hair removal and arguably have more training in skin anatomy and laser physics than any other profession chosen for light-based medical device delegation. Dr. Bechtel was so confident cosmetic therapist could be competent in performing vascular laser treatments that he reiterated that he was comfortable the rule proposal promotes public safety. We would like to be included in vascular laser delegation.

We are asking that cosmetic therapist be removed from 4781-18-03 B, 9 regarding doctor supervision up to two cosmetic therapists. As our businesses grow, we open subsequent laser machines/rooms and locations. Our qualifications to reach off site supervision are over four times more than what other delegations professions do for hair removal. As we mentioned cosmetic therapist typically only have one doctor relationship but when they have opportunities to grow there are still many barriers. We need removed from this rule so we can support the limited cosmetic therapy owned businesses to expand. These dozen or so businesses across the state are the few business entities that hire multiple cosmetic therapists. By removing this barrier, these businesses can grow into a space where they can hire within the field and we can provide career opportunities to our new graduates who did not have the chance to be in a licensed profession. We want to support more coming into our field because the demand is increasing for our services.

Another issue that would improve client care is implementing detailed guidelines about telemedicine with virtual meetings or electronic forms of communication. The largest demographic of clientele for cosmetic therapy is young adult Caucasian women who are either not on any medications or may be on birth control. This also happens to be the lowest risk candidate for laser hair removal. Our doctors are typically only available once a week and have limited office hours to our clients. If we can forward health history for Fitzpatrick scale I-III healthy adults with no medications to be virtually approved, we can start client care timelier and more become more flexible to the client’s schedule.

Exhibit 6 47 The Cosmetic Therapy Association of Ohio

Lastly, common clientele of cosmetic therapy are people who have polycystic ovarian syndrome (PCOS) which often leads to issues with acne, excessive hair growth, scalp hair thinning, and skin discoloration. Photodynamic therapy which is used to treat acne and age spots can be a tool that can assist in our clients to gain confidence, improve their self-image and mental health. We ask cosmetic therapist be added to Rule 4731-18-04 B, (2, 4 & 5) and (C-4). If a cosmetic therapist can be delegated photodynamic therapy by our doctors, we can be a full stop service for women with PCOS who struggle with cosmetic issues caused by their condition.

We hope that the rule can be updated with our comments. Our field has gone through much change with last year’s public health crisis, fluctuations to the economy, and then to have our regulatory structure altered was a lot to adapt to. Our profession did adapt well and now we need to make our barriers known so our proposal to the changes of the delegation of light based medical devices will be seriously considered for the success of our future.

Regards,

Amanda Nelson, Cosmetic Therapist President and on behalf of CTAO

Exhibit 6 48 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: CT licensure Date: Monday, May 17, 2021 8:18:20 AM Attachments: image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Reardon, Jill Sent: Sunday, May 16, 2021 10:14 PM To: Anderson, Kimberly ; Wonski, Chelsea Subject: Fwd: CT licensure

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From: Manu Aggarwal Sent: Sunday, May 16, 2021 10:05:39 PM To: Contact ; Reardon, Jill ; Anderson, Kimberly

Exhibit 6 49 Subject: CT licensure

3 Key points:

1. Cosmetic therapists spend close to a year learning hair anatomy for laser hair and electrolysis treatments. Often times, practices get a day training for these types of devices and then they begin providing these treatments. A CT is more qualified, in my opinion than even a CNP or PA or RN to provide laser treatments for hair reduction. 2. Fortunately, I employ a CT. However, those who are on their own, often times have some off site medical director they work with. Our CT, who has been with us for close to 10 years (and providing these treatments for close to 7 years) has developed relationships with patients and provides exceptional care. The combination of laser hair reduction and electrolysis is more successful for hair reduction (mainly facial hair) than one modality alone. The same is known for sclerotherapy and laser treatments for spider veins. 3. To strip away the ability of someone who has trained and provided these services is literally taking away their livelihood. I cannot imagine if the same was done to any other profession. This stripping of the earned stripes is such a disgrace for one's level of integrity. Put yourself in the other person’s shoes and try to understand their dilemma. If you know anything about medicine, this is it; compassion for the fellow provider and their patients.

Exhibit 6 50 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Marty Sweterlitsch Testimony.OMB Public Testimony 5.17.21 Date: Monday, May 17, 2021 8:19:03 AM Attachments: MSweterlitsch.testimony.4731-18 5-17-21.pdf image001.png image004.png image005.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Winder, Rachel G. Sent: Sunday, May 16, 2021 10:00 PM To: Anderson, Kimberly Cc: Loucka, Stephanie ; Wonski, Chelsea Subject: Marty Sweterlitsch Testimony.OMB Public Testimony 5.17.21

Good evening:

I hope this finds everybody well.

Please see attached the testimony that Marty Sweterlitsch, an attorney with Benesch Law

Exhibit 6 51 representing the Ohio Society of Cosmetic Therapy Training, plans to deliver during the public hearing scheduled for tomorrow.

Thank you for the opportunity and thank you for everything you all have done to help.

Warmest Regards,

Rachel G. Winder Government Relations Manager Benesch Law 41 S. High Street, Ste. 2600 Columbus, Ohio 43215 614-223-9316 - Office 614-578-9999 - Mobile

Exhibit 6 52 TESTIMONY ON MEDICAL BOARD RPROPOSED RULE 4731-18-03 On behalf of the Ohio Society of Cosmetic Therapy Training

Good afternoon. My name is Marty Sweterlitsch. I am an attorney with Benesch Law, and I am here today on behalf of the Ohio Society of Cosmetic Therapy Training to provide comments on proposed rules regarding cosmetic therapists and light-based medical devices, specifically proposed rule 4731-18-03. First, we would like to express our sincere gratitude for all the work that the Board and staff have put into these efforts after the passage of HB 442 of the 133rd General Assembly which effectively removed the regulatory structure for cosmetic therapists over a limited practice of medicine. We understand the Medical Board had no knowledge of the change prior to the passage of the law and the nearly 200 mostly women-owned businesses that operate in Ohio can continue working because of your quick action and dedicated efforts to help. We have identified four (4) areas in the rule which our clients believe provide obstacles for the profession of cosmetic therapy today and going forward. We respectfully ask the Board to consider modifying the rules to address these issues as they move through the JCARR process.

1. Probe Electrolysis using Electric Current on Face and Body is Left Unregulated We recognize that the Medical Board has limited authority after the passage of HB 442, but from a patient protection perspective and for our client that care about the professionalism of their industry and the safety of their electrology patients, it is overly concerning that electrolysis is left completely unregulated. Whenever you are dealing with an electrical current being delivered within skin to terminate the growth of hair at the dermal papilla, there is a risk of potential burn. If the provider is untrained and inexperienced with no minimum standards of sanitation and hygiene there is a risk of infection, transmission of disease, break down of the skin and a high risk of burning the skin. It is irresponsible of Ohio to leave this profession without any regulations, and we would urge the Ohio Medical Board to look at any options that potentially could be available to patients through rule.

2. The required physician involvement in the proposed training is prohibitive in terms of cost and identifying willing physicians.

Exhibit 6 53 medicine, albeit in the case of hair removal by a trained therapist, an area of limited practice, but medicine none the less. For the uninitiated, we are NOT talking about the plucking of a few eyebrow or chin hairs for improving appearance. Permanent hair removal is desirable and often necessary to a patient’s health and well being for a variety of reasons of which this Board is aware.

The training for cosmetic therapists prior to the passage of HB 442 was approved by the State Board of Career Colleges and Schools and has adequately trained practitioners for years to allow physicians to safely delegate use of a light-based medical device for hair removal. Proposed rule 4731-18-3(7) contemplates a complicated and expensive training process that requires the active involvement of a practicing physician for each student including the student observing a physician performing 20 procedures for each type of procedure for hair removal delegated and the physician personally observing 15 procedures by each student for each type of laser for hair removal delegated. Given that there are multiple types of procedures, the amount of time to be spent by the physician will dramatically increase the cost of training, and that assumes that physicians will be able and willing to devote the time required. It will be much simpler for the physician to simply delegate to a physician assistant, who will not be required to undergo any specific training. Under the rule only cosmetic therapists, Rn’s and LPNs are subject to these specific training requirements. In short, the proposed training regimen practically guarantees that no one will be able to enter the profession.

3. Current CT Students are left in limbo as are inactive, but licensed CT’s

Proposed Rule 4731-18-03(7)(e) specifies that delegates who have been applying light based therapy must be active for two years prior to the effective date of this rule. Current students are left in limbo as well as licensed CT’s who have not been actively working with laser during the immediately preceding two years. We respectfully request the Board modify this provision to accommodate these two categories of current and future Cosmetic Therapists.

4. Off-Site Supervision Should not be limited to 60 minutes travel time

Exhibit 6 54 Cosmetic Therapists cannot do their job if their delegating physician travels and, therefore, patients do not get served. We respectfully request the removal of the 60- mile limitation. The pandemic has fostered the rise of innovative medical services like telehealth and physicians can adequately assess a patient through electronic means should it be necessary to contact them. We respectfully request that the Board modify the supervision requirements and permit the physician to be available through electronic means or telehealth if available. Martha J. Sweterlitsch Benesch Friedlander Coplan and Aronoff , LLP 41 S. High St., Ste 2600 Columbus, Ohio 43215 (614) 579-6870

Exhibit 6 55 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Document 5 Date: Monday, May 17, 2021 8:20:11 AM Attachments: Document 5.docx image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: vickie aboutface-ctc.com Sent: Friday, May 14, 2021 10:38 PM To: Anderson, Kimberly Subject: Document 5

Dear Kimberly, Please present the enclosed a the JCAR meeting on Monday, May 17th. Sincerely, Vickie L. Mickey

Exhibit 6 56 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 57 About Face Cosmetic Therapy Training Center

I918 Bethel Rd. Suite A

Columbus, Ohio 43220

To Whom It May Concern:

Good afternoon! On behalf of my employees and myself at About Face Cosmetic Therapy Training Center I would like to provide comment regarding the new rules proposed by 4731-18-03.

I would like to express our gratitude for all the members of the State Medical Board and staff that put together emergency legislation regarding the delegation of light- based therapy. Without this rule the many practicing cosmetic therapist would have been severely affected financially to the point that many would have had to close their practice. Thank you for your continual support of the profession of Cosmetic Therapy.

When I became aware of Bill 442 and the impact it caused within my office of cosmetic therapy it was emotionally devasting to say the least. As you all know there was no regards to the delegation of laser hair removal. I currently own two lasers for hair removal and wondered what I was to do next!

Thank goodness the members of the OSMB enacted emergency legislation to permit the cosmetic therapist to continue to operate the laser for hair removal under physician delegation as we have done for over twenty (20) years. As I was reviewing personnel files, I realized that one of employees did not have a letter from her former delegation physician and she had not worked under the direction of the physician of About Face, Inc. for 2 years. So, I spoke to our delegating physician regarding the issue of no letter and the rule change. We had the employee do the 20 procedures of observation with our staff doctor and have had her do the necessary 30 procedures with the physician. Not only has this change in law caused major resentment from my staff member as she has been licensed as a cosmetic therapist for 11 years and has performed laser hair removal at various places of employment but did not have the necessary letter of delegation under the standards of 4731-18-03. Additionally, I had to hire the physician for many hours to meet the requirements. This employee would not have been hired at About Face, Inc. has she not been a very competent laser hair removal professional. Was this expense necessary or the need to put the employee in this position? We were not able to get a definitive answer from the OSMB as cosmetic therapy is no longer licensed under the OSMB.

Please consider changing the standards of training for cosmetic therapy back to the required 20 hours of didactic and 30 clinical hours of clinical hair removal. The new rule of delegation certainly puts a mark on the approved schools under the requirements of the State Board of Career Colleges as the schools will not be able to train future cosmetic therapist without employing a physician for many hours of over site. Additionally, if the cosmetic therapist takes a national examination for laser hair removal, why is the physician delegation of 15 hours of procedures and observations of 20 procedures by the physician required? The scope of practice for nurses, physician assistants, and nurse practitioners does not include the many hours of training required to remove hair permanently.

Thank you sincerely for the consideration of this letter.

Exhibit 6 58 Sincerely,

Vickie L. Mickey, CT,CLT

Exhibit 6 59 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: JCAR commnet for laser hair removal Date: Monday, May 17, 2021 8:20:35 AM Attachments: JCAR commnet for laser hair removal.docx image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: vickie aboutface-ctc.com Sent: Friday, May 14, 2021 10:34 PM To: Anderson, Kimberly Subject: JCAR commnet for laser hair removal

Dear Kimberly, Can you present the attached comments at JCAR meeting on Monday, May 17? Thank you for your cooperation in this matters.

Exhibit 6 60 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 61

Cosmetic Therapy Training Center

1918 Bethel Rd. Suite B

Columbus, Ohio 43220

May 14, 2021

Good afternoon. My name is Vickie Mickey with the Cosmetic Therapy Training Center with many necessary comments regarding the passage of Bill 442 and rules regarding cosmetic therapy and proposed light based hair removal rules 4731-18-03.

I would like to express sincere gratitude to State Medical Board of Ohio (OSMB) and staff for the emergency legislation for light-based therapy for hair removal. Had the members of the OSMB not moved to engage new legislation regarding 4731-18-03, it would have caused financial hardship for many of the licensed cosmetic therapist engaged in the practice of laser hair removal and disrupted the necessary treatments to prepare patients for surgeries. Thank you for the support as the cosmetic therapy community was left in the cold without direction.

As a licensed cosmetic therapist for over thirty-six (36) years, it has been an adventure to see the profession of cosmetic therapy change in the required legislation changes in 1986, which required all new electrologist to be licensed under the State Board of Cosmetology (SBOC) with only 120 hours of training, the students could not pass the examination with such few required hours, the director of the SBOC at the time approached the OSMB to put the practice of cosmetic therapy back the OSMB. The process legislative change took seven year (7), however the OSMB required 765 hours of training. The state organization worked with Lorain County Community College to install a new cosmetic therapy training program; continuing education was also enacted with the new requirement. In 1999, myself and other members of the state organization worked with the OSMB to develop rule 4731-18-03 as the only profession within Ohio that was able to permanently remove hair. Again, strong standards of education were set forth, by the OSMB requiring physician delegation to the trained cosmetic therapist. Since, 2000 I have been engaged in the training of cosmetic therapist, nurses, and physicians to meet the required hours for laser hair removal as approved by the SMBO. Of those trained, at the Cosmetic Therapy Training Center, there has never been an issue with complications. The standards of Ohio were the first in the United State that permitted an electrologist to legally operate a laser for hair removal.

Under the new guidelines of 4731-18-03, as a training institution it will require the engagement of a physician to train all the new students that attend the Cosmetic Therapy Training Center or attending the continuing education laser training program offered. This rule change will more than triple the cost of laser hair removal training if I can find a physician to do the training. Why not just use the old standards of education for the cosmetic therapist? The old standards of education have worked for over 20 years. If you survey the medical community today you will find that there are very few physicians performing laser hair removal in Ohio as the cost of the procedures have been affected by Groupon. The

Exhibit 6 62 dermatologist down the street from my office sends all her hair removal patients to About Face Cosmetic Therapy Center, which is my office.

Bill 442 was enacted to enable other people to come into Ohio, engage in the profession of permanent hair removal without any rules or regulations. Personally, the consumer is going to be subjected to many under trained electrologist. The national standards of care required for electrology are 600 hours on the average. As the electrologist is highly trained in the permanent removal of hair, the laser hair removal is just another tools in their toolbox if the training is delivered in the proper format. Often the patient needs laser hair removal to reduce most of the hair in an area and needs electrolysis to finish the resistant hair, gray hair, red hair or white hair.

Thank you for your time and please consider changing the standards of 4731-18-03 to permit the electrologist that is well trained and certified to be able to serve to community of patients that needs our services.

Sincerely,

Vickie L. Mickey, CT,CLT

President

Exhibit 6 63 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Marley Miller JCAR Meeting letter Date: Monday, May 17, 2021 8:20:16 AM Attachments: Marley Miller JCAR Meeting letter.docx image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: vickie aboutface-ctc.com Sent: Friday, May 14, 2021 10:36 PM To: Anderson, Kimberly Subject: Marley Miller JCAR Meeting letter

Dear Kimberly, Can you please present the attached comments during the JCAR meeting on Monday, May 17th.? Sincerely, Marely Miller

Exhibit 6 64 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

Exhibit 6 65 Marley Miller

5721 Heritage Lakes Dr.

Hilliard, Ohio 43026

To Whom It May Concern:

The passage of Bill 442, as a student it was difficult to have been enrolled at the Cosmetic Therapy Training Center under the prior laws of training which required 765 hours of training that was approved by the State Board of Career Colleges and Schools. Within this training I had already completed the required Twenty (20) hours of didactic training, and the thirty (30) hours of clinical laser hair removal. Then to find I needed more training to be able to operate the laser for hair removal. When Bill 442 passed with no guidelines requiring training it completely disrupted the standards of prior education. When the new rules 4731-18-03 was adopted by the State Medical Board of Ohio, it required the physician at the Cosmetic Therapy Training Center to provide an additional twenty (20) procedures of laser observation, plus another thirty (30) procedures of laser hair removal training with the physician on site. Please realize that there is not one state within the United States that required this amount of training for laser hair removal for any electrologist, nurse, physician assistant, or nurse practitioners.

Additionally, Bill 442 left no standards of care for the cosmetic therapy in Ohio. The investment of over seventeen thousand ($17,000.0)) dollars to complete the unregulated program was very confusing as Bill 442 did not require any training or rules and regulations. I have remained in the program and obtained the requirement of both the prior rules of training and still completing the additional hours to take a certification examination in the future.

Electrology and laser hair removal work hand in hand to assist the necessary hair removal for many patients today as the census for PCOS and transgender reassignment has gone up. Only the well trained electrologist can perform these much-needed procedures to aid in the emotional and physician changes for people in our society today.

Thank you for your cooperation in this matter.

Sincerely,

Marley Miller

Exhibit 6 66 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: CTAO Comments on Light Based Delegation Rule Date: Monday, May 17, 2021 8:22:18 AM Attachments: CTAO Comments on 4731-18-03 Light Based Medical Devices 2021.pdf image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Cosmetic Therapy Association of Ohio Sent: Friday, May 14, 2021 5:54 PM To: Reardon, Jill ; Anderson, Kimberly ; Loucka, Stephanie Subject: CTAO Comments on Light Based Delegation Rule

Hello,

Please see our attached letter regarding comments on the proposed changes to the light based delegation rule.

Sincerely,

Exhibit 6 67 Amanda Nelson President The Cosmetic Therapy Association of Ohio Board

Exhibit 6 68 The Cosmetic Therapy Association of Ohio

May 14, 2021

Kimberly Anderson, Chief Legal Counsel State Medical Board of Ohio

Exhibit 6 69 The Cosmetic Therapy Association of Ohio

Exhibit 6 70 The Cosmetic Therapy Association of Ohio

Regards,

Amanda Nelson, Cosmetic Therapist President and on behalf of CTAO

Exhibit 6 71 From: Anderson, Kimberly To: Rodriguez, Judith Subject: FW: Comments on proposed rule: Use of light based medical devices Date: Monday, May 17, 2021 8:22:20 AM Attachments: ASDSA Comments - Support - OH Regs on light based devices.pdf image001.png image003.png image004.png

Kimberly Anderson Chief Legal Counsel State Medical Board of Ohio 30 East Broad Street, 3rd Floor Columbus, Ohio 43215 o: 614-466-7207 c: 614-230-9077 [email protected]

From: Emily Besser Sent: Friday, May 14, 2021 4:47 PM To: Anderson, Kimberly Subject: Comments on proposed rule: Use of light based medical devices

Dear Ms. Anderson, On behalf of the American Society for Dermatologic Surgery Association, please see the attached comments in support of the proposed rule “Use of light based medical devices.” If you have any questions, please do not hesitate to contact me,

Best, Emily

Exhibit 6 72

Emily Besser, MA, CAE (she/her/hers) Manager of Advocacy and Practice Affairs American Society for Dermatologic Surgery Association (ASDSA) 5550 Meadowbrook Drive, Suite 120 Rolling Meadows, IL 60008 Direct: 847-956-9121 Cell: 708-204-9271 [email protected] https://www.asds.net/ASDSA-Advocacy

Access key resources and information on getting involved in advocacy · Learn how to get involved in advocacy activities that benefit you and your practice · Save the dates for the 2021 ASDS / ASDSA Annual Meeting: Oct. 14-17 in Chicago; Nov. 19-21 Virtual.

Exhibit 6 73

May 14, 2021

Ms. Kimberly Anderson Ohio State Medical Board 30 East Broad Street, 3rd Floor Columbus, OH 43215 Delivered electronically: [email protected]

RE: Proposed Rules: 4731-18-02 Use of light based medical devices

Dear Ms. Anderson,

As President of the American Society for Dermatologic Surgery Association, representing over 6400 dermatologic surgeons, I am writing to express our support of the proposed rule “Use of light based medical devices.” These commonsense regulations ensure that any light based medical procedures are delegated to the correct individuals and that a physician is on-site at all times to supervise non-physician providers.

We appreciate the opportunity to provide comments on this important public health issue. In order to protect the citizens of Ohio from adverse events and to ensure quality care, I urge you to support this proposed rule change. For further information, please contact Emily Besser, Manager of Advocacy and Practice Affairs, at [email protected] or (847) 956-9121.

Sincerely,

Mathew Avram, MD, JD, President American Society for Dermatologic Surgery Association cc: Sue Ellen Cox, MD, President-elect Vince Bertucci, MD, FRCPC, Vice President Dee Anna Glaser, MD, Treasurer Kavita Mariwalla, MD, Secretary Marc D. Brown, MD, Immediate Past President Katherine J. Duerdoth, CAE, Executive Director Kristin A. Hellquist, MS, CAE, Director of Advocacy and Practice Affairs

Exhibit 6 74 Lee, Kimberly

From: Anderson, Kimberly Sent: May 17, 2021 1:58 PM To: Lee, Kimberly Cc: Rodriguez, Judith Subject: Fwd: 4713-18-03

Sent from my iPhone

Begin forwarded message:

From: Kelly Statzer Date: May 17, 2021 at 1:36:47 PM EDT To: "Anderson, Kimberly" Subject: 4713-18-03

Dear Ms. Anderson,

I am writing with concerns over the new rule changes for light-based therapies.

I believe this new rule change is very complicated as we have yet to get clarification on whether or not each doctor will be required to “ensure” that each person they are delegating to has been properly trained on the laser. I believe it is going to be very difficult to find a physician willing to do this. But if so, is going to be very costly on the part of the business owner or person they are delegating to. We have never had to do this in the past 20 years and I don’t believe CTs have given the Board any reason add regulations to our profession.

The distance minimum restriction has been problematic for us. If our physician goes out of town for two weeks, more than 60 minutes away, we are required to cancel all of our clients for the time that our physician is out of town, which prevents us from bringing in any income

On-site supervision of a physician during consultations and test spots limit us to specific days. We are unable to start treatments immediately because of this. Physicians may only come in twice a month to do initial consult until spots, preventing the consumer for beginning their treatments until a later date.

Because we are living in a new age of pandemics, it just seems that we should be allowed to work by way of telemedicine to eliminate exposure. There seems to be no reason why we can’t communicate with a physician through telemedicine. Healthcare has expanded. We have urgent cares on every street corner. Cameras are 1 Ex. 7 better than they have ever been. Technology has advanced to allow for off-site communication.

Sincerely,

Kelly Ott-Statzer

Sent from Yahoo Mail for iPhone

2 Ex. 7 Lee, Kimberly

From: Domer, Dana Sent: May 17, 2021 2:20 PM To: Lee, Kimberly Subject: Todays Hearing Comments allowed until 5pm today!!

Hello Ms. Lee, I listened to the webinar today regarding laser and light based devices. I am a Physician Assistant and I have been working as a PA for 23 years. I am now in PA education. I am writing in favor of allowing laser and light based devices to be used by PAs. Physician Assistants are trained in all kinds of procedures. They are very procedure oriented. Whereas Nurse Practitioners are not procedure oriented in their training, yet they are allowed to use these devices. I have a PA colleague that was trained by her physician to use these light based devices. She was able to use these devices in Pennsylvania, but then moved to Ohio to take a job here with a plastic surgeon. She is now unable to continue the use of these devices, which is deterring her from being able to take care of her patients fully. I completely believe that Physician Assistants are competently trained and are completely qualified to be able to use these devices with the initial OK from their collaborating physician. If you are able to look into the training of the PAs, you will see that it is 15 months of medical study, then 10 months of clinical training. Through all this training the PA student must prove their competencies in performing procedures. I hope this helps in your decision making. All the best, Dana J. Domer MPAS, PA-C

Dana J. Domer MPAS, PA-C Assistant Professor and Clinical Coordinator University of Mount Union PA Studies Program Gallaher Hall 109 1972 Clark Ave Alliance, OH 44601 Phone: 330-823-4885 Fax: 330-829-6168

PAs are licensed to practice medicine which includes but not limited to: assessment, diagnosing, treating and prescribing medications while collaborating with the entire healthcare team.

1 Ex. 8 CAUTION: This is an external email and may not be safe. If the email looks suspicious, please do not click links or open attachments and forward the email to [email protected] or click the Phish Alert Button if available.

2 Ex. 8 Lee, Kimberly

From: Shannon Sent: May 17, 2021 2:47 PM To: Lee, Kimberly Subject: Light Based Medical Devices -PAs

Dear Ms. Lee,

My name is Shannon Urena and I am a practicing board certified PA-C in the state of OH. I am commenting on OAC rule 4731-18-02, as it has affected our practice greatly and many PAs in the state of OH. I am practicing within a Plastic Surgery Department at Aultman Hospital, in Canton OH. Our specialty encompasses, but is not limited to the treatment of: skin cancer, lesions both benign and malignant, cosmetics, and scars.

PA’s are board certified in medical education and undergo many rigorous hours of training. I would argue that PAs have almost the same amount of hours in training as a physician, without residency training. For example, MDs and DOs accumulate approximately 182 credit hours in didactic, where PAs accumulate approximately 128 credit hours in didactic. In regards to clinical hours, MDs and DO accrue approximately 3000+ where PAs accrue approximately 2,000+.

PAs are highly qualified and have exceptional training. It is disappointing our current laws have not been updated to compliment the new PA laws. Allowing PAs to use light based medical devices would greatly improve patient access to those treatments.

I would also like to further comment in regard to Dr. Foad’s testimony today from Mona Dermatology. Her comments resonated with our practice in that it has only left me to reschedule patients months out with a physician before receiving proper care and treatment. It has also taken away the ability of PAs to treat their patients in a timely manor.

This is very costly to our practice and prohibitive to PAs in the state of OH.

I understand that the Medical Board has been revisiting rule 4731-18-02. However, I strongly urge you to review as expeditiously as possible.

If there are any updates regarding this decision or if I can be of assistance in the process, please let me know.

Respectfully,

Shannon

-- Shannon Urena, M.S., M.S., PA-C Rutgers University Class of ‘19 Vice President | RU PA Class of ‘19 Class Representative | Committee on Academic Integrity, Professionalism, & Disciplinary Review M.S. Human Biology

1 Ex. 9 C: 732-804-4565 E: [email protected]

2 Ex. 9 Lee, Kimberly

From: Angie Dreimiller Sent: May 17, 2021 4:05 PM To: Lee, Kimberly Subject: CO2 lasers and PAs in Ohio

Hello Kimberly,

Not sure why we limited in the use of CO2 lasers, but hoping this will change in legislation.

Thank you for taking the time to read this and hopefully action will be taken forward.

Angelina Dreimiller PA-C

1 Ex. 10 Lee, Kimberly

From: Serina Abdul Satter Sent: May 17, 2021 5:28 PM To: Lee, Kimberly Subject: CO2 Laser: Ohio PAs are more than Qualified

Hello,

Best, Serina Abdul Satter

1 Ex. 11 Lee, Kimberly

From: Anderson, Kimberly Sent: May 17, 2021 6:54 PM To: Lee, Kimberly Subject: Fwd: Cosmetic Therapy Proposals

Sent from my iPhone

Begin forwarded message:

From: I Date: May 17, 2021 at 5:54:00 PM EDT To: [email protected], [email protected], [email protected], "Anderson, Kimberly" Subject: Re: Cosmetic Therapy Proposals Reply-To: I

RE the Cosmetic Therapy Proposals:

A BIG NO to JVS training. Since this is a quasi medical professional and CTs are wanting to be appreciated and respected as being "professionals", training should be done once the applicant is 18, has proof of HS graduation or GED equivalent, passes a criminal background check, and training be done at a community college or technical college equivalent such as Lorain County Community College, North Central State, Cuyahoga Community College. JVS training will not garner respect. Plus, business law, etthics, college level Anatomy and Physiology are an important part of the curriculum aside from the electrology portion of the training. This has nothing to do with younger eyes and better vision.

I have spoken to two of the department heads at the Cosmetology Board. Cosmetic Therapists are not required to be in a salon "we can practice anywhere we would like to practice". I am in a salon and am my own LLC. I am NOT required to get an independent contractor license because I am not licensed. I just have to follow the sanitation rules that all salons must follow. That is how the Cosmetology Board is going to address Cosmetic Therapists and sanitization. As a member of the AEA, I actually go above and beyond those standards by following the OSHA standards.

Jeanne Griebling CT

-----Original Message----- From: Kelly Statzer To: Vickey Mickey Sent: Mon, May 10, 2021 8:35 am Subject: Cosmetic Therapy Proposals

Good Morning, Please see our attached our proposal below. In government, there are laws and rules. Laws are written by the state legislators and rules are written by state and federal agencies and licensing boards. Laws override rules. There are two proposals being offered. One proposal is recommending we continue following ever-changing rules as “unlicensed” cosmetic therapists under the Cosmetology Board for “infection control” and the Medical Board for the use of the laser as we have been doing for the last 20 years, but with more increased regulation than we had in place before, 1 Ex. 12 adding unnecessary burden to a profession that has already been hit hard financially from the pandemic by requiring each physician to “ensure” those performing laser are properly trained by performing 15 treatments in front of the technician and observing 20 treatments performed by the technician for each device used. The other proposal being offered is to create a permanent solution by writing a new law that more clearly defines our profession and provide us with the necessary tools to be successful in our businesses. We would no longer be under the cosmetology board to receive random inspections from a regulating body that has yet to define sanitation and sterilization practices specific to electrolysis. We would still be monitored by the Medical Board who would primarily be involved in inspecting our offices if a complaint is filed. WE WILL NOT BE UNDER THE HEALTH DEPARTMENT. That said, the only licensing body that will be responsible for us will be the Medical Board and that is only if there is a complaint filed against one of us. If there is a complaint filed against one of us, the Medical Board, and only the Medical Board, can come to our offices and make sure we are following "the law" that we have written out for ourselves. The opposition is recommending we be under both the Cosmetology Board and the Medical Board, which means at any given time either board can write rules for our profession. The opposition is stating these rules are a "permanent" fix, but they are NOT a "permanent" fix. And, it is possible that we may be forced to work in a salon through changes in the rules. The following is a question from a Q&A put out by the cosmetology board, which I have attached below: Q2. Can Cosmetic Therapists practice independently, or will we be required to practice only in a salon? A: Individuals can practice independently OR may practice cosmetic therapy in a salon if authorized by and according to rules made by the Ohio State Cosmetology and Barber Board. Key Words: "if authorized by and according to rules made by" Are we now considered a "branch of cosmetology?" Many are unaware that the cosmetology board currently has new rules in the CSI office that are headed to JCARR for final approval relating to unlicensed individuals, unlicensed salons, unlicensed shops, and unlicensed home salons. If we are required to be in a salon, we will be required to register as a salon with the cosmetology board and hold an independent contractor's license under them. Our proposal (attached below) will be a permanent fix. It will be law, meaning we will not be required to follow ever-changing rules passed down by either licensing board. The language for our profession will be put into law, not rules. We will have more control in defining our profession by putting it in law. We will be able to define ourselves and provide for our own needs, which will no longer be dependent on licensing boards that have shown an unwillingness to reach across the aisle to discuss our obstacles, concerns, and needs. Let’s face it, we have seen many changes in the last 20 years. The internet was fairly new when the laser first came on the scene. We have a golden opportunity here to truly define and grow our profession. One of the goals is to open up our profession. The number of people going into our profession has been steadily decreasing over the last 20 years. We would like to see an increase in the number of electrologists in the state of Ohio and we believe there is plenty of business to go around. We have a population of 11.6 million people and only 180 electrologists. Some consumers must drive 100+ miles to seek out our services. We are decreasing the education to 600 hours, which is considered the National standard with the addition of 50 hours for those who chose to run the laser. We are NOT creating a National certification, but if someone has a spouse who is in the military and they move frequently, we are providing them with the option to take the National certification exam

2 Ex. 12 through AEA. We are also allowing those who choose to take the state test the ability to do that as well. We are allowing those who want to do massage the ability to do that too. WE HAVE NOT TAKEN ANYHING AWAY. We have only provided more flexibility and created individuals with more options while maintaining high standards. We have provided an avenue to teach electrolysis in vocational schools, which can be taught in a high school setting to be offered as a trade skill. There are already a few healthcare programs that are offered through vocational education for 11th and 12th grade. Medical lab assisting is one of the programs offered, which includes phlebotomy as part of the curriculum (12th grade). One thing worth pointing out is that younger individuals tend to have better eyesight and tend to pick up the art of flawless insertions much more quickly. These are 2-year programs. Cosmetology has been taught in vocational schools for decades. Students can easily complete the hours required in that amount of time. By the time these students take their exams, they would be 18 years of age and would be well on their way to beginning a new career. We have added galvanic treatments to our scope of practice as well as any other treatment that may aid in hair removal (i.e. glycolic peels, microdermabrasion, dermaplaning, waxing, etc.) Neither the cosmetology board or the medical board will allow that in their rule making. But we are putting this into law and they will not be able to override it. Many of these treatments were not even available 20 years ago. Training for these treatments can easily be obtained through continuing education. Again, we are trying to keep what we have and open up the profession even more by adding the necessary treatments to help us efficiently and effectively remove hair. Some of you have asked about sales tax and we are prohibiting the state from charging sales tax for electrolysis as we are providing a medical service. We are also including complete telemedicine for consults and test spots with zero distance minimum, which we feel is important considering the ongoing pandemic and the fact that we work without the physician onsite 99% of the time anyway. The Medical Board has failed to include telemedicine in their proposal, but since we have put this into law, the law will override the Medical Board rules. We need a great deal of support if we are to get this new law through. Rachel, our lobbyist, and Martha, our attorney, have worked diligently to gain an understanding of our profession to determine what our needs are. They have truly thought of everything. They have done a phenomenal job in looking out for our profession to protect us long-term. Any response you could provide in support of our proposal would be greatly appreciated. Of note, there is an upcoming JCARR committee meeting scheduled in Columbus, Ohio at 1:30 pm on May 17, 2021. If you cannot attend, please make your voices heard by submitting a response to the lobbyist, Rachel, which will be sent to JCARR. Rachel Winder - [email protected] Thank you. Kelly Ott-Statzer

3 Ex. 12 *** DRAFT - NOT YET FILED *** 4731-18-01 Definitions.

As used in this chapter of the Administrative Code:

(B) “Phototherapy” means the following:

(1) For paragraph (A) of rule 4731-18-04 of the Administrative Code, phototherapy means the application of light for the treatment of hyperbilirubinemia in neonates.

(D) “Ablative dermatologic procedure” means a dermatologic procedure that is expected to excise, burn, or vaporize the skin below the dermo-epidermal junction.

(E) “Non-ablative dermatologic procedure” means a dermatologic procedure that is not expected or intended to excise, burn, or vaporize the epidermal surface of the skin.

(G) “Delegation” means the assignment of the performance of a service to a person who is not a physician.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Mar 12, 2021 12:00, (dv: 0] print date: 03/12/2021 01:47 PM *** DRAFT - NOT YET FILED *** 4731-18-01 2

(A) The application of light based medical devices to the human body is the practice of medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery.

(B) A physician shall not delegate the application of light based medical devices for ablative procedures.

[ stylesheet: rule.xsl 2.14, authoring tool: i4i 2.0 ras3 Apr 7, 2021 11:21, (dv: 0] print date: 04/07/2021 11:21 AM *** DRAFT - NOT YET FILED *** 4731-18-02 Use of light based medical devices.

(B) The application of light based medical devices to the human body is the practice of medicine and surgery, osteopathic medicine and surgery and podiatric medicine and surgery.

[ stylesheet: rule.xsl 2.14, (dv: 0] print date: 03/12/2021 01:48 PM

*** DRAFT - NOT YET FILED *** 4731-18-03 Delegation of the use of light based medical devices for specified non-ablative procedures.