Meeting Packet - Professions and Public Health Subcommittee (November 3, 2021)
Summary
Meeting packet for the Professions and Public Health Subcommittee, Wednesday, November 3, 2021, with Chris Sprowls as Speaker and Will Robinson as Chair. It includes a Department of Health presentation by Paul A. Vazquez on Office Surgery under HB 933 (2019), with a table showing office registrations of 619, 651 and 685 for 2019, 2020 and 2021 YTD. It includes a Prescription Drug Donation Repository Program update by Niaz Siddiqui, which states a Notice of Proposed Rule was published on September 17, 2021. It also includes slides from Almut Winterstein on the Consortium for Medical Marijuana Clinical Outcomes Research, which state that the University of Florida was designated lead university of the Consortium in July 2019.
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“Meeting Packet - Professions and Public Health Subcommittee (November 3, 2021).”
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Professions and Public Health
Subcommittee
Wednesday, November 3, 2021
11:00 AM - 12:30 PM
Webster Hall (212 Knott)
Meeting Packet
Chris Sprowls Will Robinson
Speaker Chair
Committee Meeting Notice
HOUSE OF REPRESENTATIVES
Professions & Public Health Subcommittee
Start Date and Time: Wednesday, November 03, 2021 11:00 am
End Date and Time: Wednesday, November 03, 2021 12:30 pm
Location: Webster Hall (212 Knott)
Duration: 1.50 hrs
Department of Health implementation update on:
- Office Surgery, HB 933 (2019)
- Prescription Donation Program, HB 177 (2020)
Presentation on Medical Marijuana Research:
Implementation update on SB 8A (2017) medical marijuana research provisions by Dr. Almut Winterstein,
Director, Consortium for Medical Marijuana Clinical Outcomes Research
For information about attending or testifying at a committee meeting, please see the “Visiting the House”
tab at www.myfloridahouse.gov.
NOTICE FINALIZED on 10/27/2021 4:01PM by Osborne.Erin
10/27/2021 04:01:37PM Leagis ® Page 1 of 1
Office Surgery
Department of Health
Medical Quality Assurance
Legislative Implementation Update
Paul A. Vazquez, J.D.
Executive Director, Florida Board of Medicine
Division of Medical Quality Assurance
Florida House of Representatives
Professions & Public Health Subcommittee
November 3, 2021
HB 933 (2019) Office Surgery
• Overview of HB 933
o Registration Requirements
o Enforcement
o Disciplinary Penalties
• Implementation Strategies
o Florida Department of Health
o Florida Board of Medicine
o Florida Board of Osteopathic Medicine
• Enforcement Summary
• Next Steps
2
2
HB 933 (2019) Office Surgery Overview
• Requires registration of office surgery facilities.
• Provides authority for unannounced inspections.
• Establishes disciplinary penalties for offices and practitioners.
3
3
HB 933 (2019) Office Surgery Registration
Office Registration
Designated Physician
Registration
Financial Responsibility
Practicing Physician Registration
4
HB 933 (2019) Office Surgery Inspections
Annual Inspections*
Enforcement
Unannounced Inspections
* Unless the office is accredited by a nationally recognized accrediting agency approved by the Board.
5
HB 933 (2019) Office Surgery Discipline
Suspension or Revocation of Office Registration
Disciplinary Emergency Order Suspending or Restricting Registration
Penalties
Penalties for Designated Physician
$5,000 Fine for Practicing Physician (per day)
6
Rule Promulgation
Florida Boards of Medicine and Department of Health
Osteopathic Medicine
• Office registration requirement. New facility application created:
• Designated physician requirement. • Facility ownership information.
• Physician registration requirement. • Designated physician identification.
• Financial responsibility requirement. • Surgeon information and qualifications.
• Physician compliance with standard of care • Disclosure of other personnel.
as a condition of registration. • Accreditation status.
• Criminal history disclosure.
• Liability coverage disclosure.
7
Office Surgery Registrations
685
700
680 651
660
619
640
620
600
580
2019 2020 2021 YTD
Office surgery facility registrations have continued to increase.
8
Office Surgery Enforcement Inspections
2019 2020* 2021 YTD
Office Registration 619 651 685
Accredited Offices 184 155 186
Inspections Completed 437 48 397
*2020 – Executive Order 20-72 suspended all non-essential, elective, medical and surgical procedures.
9
Office Surgery Complaints
132
140
120
80
100
80
60
40 8
20
0
2019 2020 2021 YTD
Investigations of office surgery complaints have resulted in
one registration suspension and two emergency restriction orders.
10
Next Steps
• Ensure compliance with the office surgery application process.
• Assess qualifications of physicians seeking to associate with office surgery
facilities.
• Discipline physicians who operate outside the scope of practice or who violate
standards of care.
• Seek registration revocation of facilities operating outside the scope of the
definition of an office surgery facility.
• Continue routine Surgical Care and Quality Assurance committee meetings.
11
Questions?
Contact:
Paul A. Vazquez, J.D.
Executive Director
(850) 245-4130
Paul.Vazquez@flhealth.gov
12
12
Prescription Donation
Program
Department of Health
Prescription Drug Donation Repository Program
Implementation Update
Florida House of Representatives
Professions & Public Health Subcommittee
November 3, 2021
Department of Health
Niaz Siddiqui, PharmD, MBA, Chief
Bureau of Public Health Pharmacy
Division of Emergency Preparedness
and Community Support
Florida Department of Health
2
Overview of Program
Section 465.1902, Florida Statutes, effective July 2020
(HB 177, enrolled February 19, 2020)
Purpose: “The Prescription Drug Donation Repository Program
(PDDR) is created within the department to facilitate the donation of
prescription drugs and supplies to eligible patients.”
Requires establishing three key elements and associated forms:
Eligible repositories
Eligible prescription drug donors
Eligible patients
3
Forms
Each of the following forms has been developed:
• Repository Application and Withdrawal Form
• Patient Application and Dispensing Form
• Donor Form
• Destruction of Drugs Form
• Transfer Form
• Inventory Form
4
Rule Promulgation
Development of program processes, forms, and program guide.
Development of draft rule language and required forms.
Chapter 64J-4 in the Florida Administrative Code establishes the program.
Rule workshop held May 16, 2021.
Required forms and process maps edited during June and July 2021.
5
Rule Promulgation (continued)
Notice of Proposed Rule submitted to Department of State and published on
September 17, 2021.
Received comments from Joint Administrative Procedures Committee (JAPC).
Rule hearing held on October 18, 2021.
Notice of Change-Early November 2021.
6
Outreach Activities
Launched program website.
Conducted complete national review of drug donation programs.
Met with Iowa and Wisconsin PDDR programs to research and identify best practices.
Florida Association of Free and Charitable Clinics (FAFCC)
Met with FAFCC Executive Director.
Met with FAFCC members to research and identify best practices.
Confirmed to speak at the FAFCC annual conference in November to promote awareness and
encourage participation.
Finalizing communication and outreach strategy.
7
Next Steps
for Program Implementation
Finalize rule promulgation.
Obtain budget authority for grant funds received (will support maintenance of
program and automation of system).
Send promotional emails to eligible entities.
Utilizing mailing lists from the Agency for Health Care Administration
and DOH Medical Quality Assurance.
Conduct post implementation evaluation.
Incorporate feedback into processes, program guide, webpages and
forms as appropriate.
8
Questions or Comments?
For additional information, please contact:
Victor Johnson, Section Administrator
Emergency Preparedness and Community Support
850-245-4346, Victor.Johnson@flhealth.gov
Niaz Siddiqui, PharmD, MBA, Chief, Bureau of Public Health Pharmacy
850-922-9036, Niaz.Siddiqui@flhealth.gov
Shannon Hughes, Project Manager
850-841-8525, Shannon.Hughes@flhealth.gov
9
Medical Marijuana
Presentation
The Consortium for
Medical Marijuana Clinical Outcomes Research
Almut G Winterstein, RPh, PhD, FISPE
Director
Distinguished Professor & Chair, Pharmaceutical Outcomes & Policy, University of Florida
Director, Center for Drug Evaluation and Safety (CoDES), University of Florida
Professions and Public Health Subcommittee
House of Representatives
Nov, 2021
1
Section 1004.4351, Florida Statutes
d
'.I
• Established the Consortium for Medical Marijuana Clinical Outcomes
Research to conduct, disseminate and support rigorous scientific research on
the clinical outcomes of medical marijuana use.
• In July 2019, the Florida State University System Board of Governors,
following a competitive request for proposals, designated the University of
Florida as the lead university of the Consortium.
2
Why we exist…
Despite … the rapid rise in the use of cannabis both
for medical purposes …, conclusive evidence
regarding the short- and long-term health effects
(harms and benefits) of cannabis use remains elusive.
A lack of scientific research has resulted in a lack of
information on the health implications of cannabis
use…
Recommendations:
• Develop a comprehensive evidence base
• Improve research quality
• Improve surveillance capacity
• Address research barriers
Number of Medical Marijuana Qualified Patients per
Month, FL Jan 2018 – Oct 2021
National Academies of Sciences, Engineering & Medicine 2017
https://www.nap.edu/download/24625 3
Consortium Structure
• Consortium Board composed of
1 representative from each
member institution
• Director serves at discretion of
the board
• Funded through direct annual
state appropriation
• Consortium has annual
reporting requirement to
governor and legislature that
must include an annual
research plan.
4
Consortium Research Program
• Grants program: offered annually to
Grants members; research focus based on statutory
program guidance and the annual Consortium
research agenda
• MEMORY: a new and unique research data
repository available to members
Evidence MEMORY
• Clinical core: provides infrastructure support
for prospective studies; about to launch M3
• Outreach: CCORC; newsletters; website,
conference exhibits; provider survey
• Evidence: develops research priorities;
Outreach Clinical core publishes Evidence in Context series and
patient info sheets
5
Grants Program Progress
2019 2021
41 proposals 24 proposals
10 awards 11 awards
(to 5 universities) (to 5 universities)
Final reports released
20 proposals
9 awards
(to 5 universities)
Interim reports received
2020
6
2021 Research Priorities
Clinical Route &
outcomes dose
Inter- Epide-
actions miology
Endocan-
Com-
nabinoid
ponents
system
https://www.karger.com/Article/FullText/515069
7
Consortium Grants Program: > $1.97 million awarded
Negative
Brain & Pain of various
Cancer emotion &
muscle injury origins
photophobia
85
proposals Medical
Drug
Pattern and
marijuana PTSD motivation for
Interactions
access in FL use
30 grants Olfactory Anorexia
awarded Anxiety
function nervosa
Neuropathy
MMJ/CBD use Role of
Adverse Drug Reducing
among Nursing Endocanna-
Home Patients Events Inflammation
binoids
8
Clinical Core
• Patient Contact registry –
439 enrolled participants
Contact
• CARMMA – Connecting and advancing CARMMA
research in medical marijuana database
registry
of collaborating researchers, clinicians
and industries
• Guidance for investigators on regulatory
issues involving use of MMJ in research
studies Guidance M3
• Medical Marijuana and Me (M3) – new
prospective cohort
9
Patient Contact Registry (https://mmjoutcomes.org/registry/)
Clinics assisting in patient recruitment Location of registered patients 10
Medical Marijuana and Me (M3): Strategic Goals
1) Collect patient-centered data to
characterize the experiences and
clinical outcomes among a
diverse group of medical
marijuana users in Florida.
2) Provide access to data and
recruitment infrastructure for
Consortium researchers.
3) Support high-quality research
that can inform state policy and
clinician practice and improve
patient outcomes related to
medical marijuana.
11
Outreach: CCORC (225 registrations)
12
CCORC 2022
d
'.I
13
Other Ongoing Outreach Activities
• Media interviews, press
releases, participation in
conferences
• MEDICAMENT (quarterly
newsletter) 8 issues
disseminated to 472 individuals
• Website: mmjoutcomes.org
14
Evidence
• New Evidence-in-context
series
• Updates on research
priorities
• Maintains expert panel
• Patient Info Sheets
• The endocannabinoid
system
• Ways to consume MMJ
• MMJ for treatment of
anxiety and pain
• MMJ Interactions with
prescription drugs
15
Regulatory timeline involving medical marijuana research in FL
2014 Compassionate Medical
January 2017 July 2019
Cannabis Act
381.986(2)(e) requires physicians Presentation to Health Quality Consortium for Medical Marijuana
to submit a treatment plan Subcommittee to propose Clinical Outcomes Research
quarterly to the UF College of comprehensive Medical Marijuana UF selected by BOG to lead the
Pharmacy for research on the Surveillance System Consortium
safety and efficacy of low-THC
cannabis on patients
New Coalition for Medical
Marijuana Research and Education
Requirement for data collection for
UF removed; DOH to start registry
UF launches website to Registry certification data submitted
collect treatment plans to the coalition
July 2016 July 2017
16
2017 proposal
Real-world evidence on medical
marijuana safety and effectiveness
requires data that provides
• Detail on medical marijuana use
• Detail on patient clinical history
• Longitudinal follow-up to
ascertain outcomes
• Control groups
17
MEMORY: MEdical Marijuana Clinical Outcomes RepositorY
Integrated data repository that captures
medical marijuana utilization and clinical
outcomes
• Unique resource nationally
• Supported by statute
MEMORY will support:
• controlled studies on MMJ effectiveness and
safety and
• active surveillance to capture emerging safety
issues among MMJ users.
18
MEMORY - Progress
OMMU registry
data access per 1004.4351 (4)(f): Beginning August 1, 2019 and quarterly thereafter, DOH shall submit for
current law each patient in the registry, the patient’s qualifying medical condition, … daily dose, routes of
administration, and forms of marijuana certified for the patient.
381.987(2)(h): The department shall allow access to confidential and exempt information in
the medical marijuana use registry… to the Consortium
381.987(3)(b): The department shall allow access to the confidential and exempt information
pertaining to the physician certification for marijuana and the dispensing thereof, whether in
the registry or otherwise to the Consortium …… for the purpose of conducting research
regarding the medical use of marijuana.
Request Broad request for identifiable data (to allow data linkage) with both certification and
dispensing detail for all patients in the registry
Vital Stats (BC/DC) Medicaid MMUR 19
MEMORY – Progress contd.
DoH IRB
AHCA OMMU DUA
DoH Vital drafted but
UF IRB Medicaid DUA signed by UF,
DUA not submitted
approved approved; under review
approved because of
data received by DoH
pending DUA
New communication with DoH/OMMU started in spring 2021, which outlines three steps:
1. OMMU registry access approval – completed: access to a deidentified version of the OMMU
registry along with automated queries
2. DUA for provision of deidentified data per 1004.4351 – reviewed and returned by UF with edits to
DoH on 8/17/21
3. DUA for provision of identifiable data including dispensing data - pending
20
Scope of work for MEMORY (reflected in approved IRBs/DUAs)
d
'.I
• Safety of medical marijuana considering variety of
• sub-populations defined by clinical indication or specific high-risk status (e.g., pregnancy)
• adverse events (e.g., psychosis, cognitive development, injury)
• doses, routes, concomitant medications and other factors, such as comorbidities that may
alter effects.
• Effectiveness and comparative effectiveness of medical marijuana for a variety of
• indications (e.g., effects on pain management, anxiety, PTSD)
• doses and routes and
• patient characteristics that may affect outcomes.
• Effects of certification standards on access, utilization patterns and outcomes of medical
marijuana.
• Active surveillance of emerging health issues and specific products or routes of
administration.
21
Consortium
Staff
22
Consortium Board Members
William Martha s. Charles A.
Anderson, PhD Rosentha l, PhD Weatherford,
(Chair) (Vice Chair) PhD
Florida Florida Gulf Coast Flcrid;:iA&M
International University University
Universi!Y, Ximena Levy, Max.C.E. Eric H. Holmes,
MD,MPH,CIP Orezzoli, PhD PhD
Florida Ailantic Florido Memorial Florida State
University Universily Universiiy
Timothy Roger B. Jacqueline
Gil bertson, PhD Fillingim, PhD Sagen, PhD,
Universi1y of University of Florida MBA
Cen Lral Florida University of Miami
23
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