The Florida Senate
                    BILL ANALYSIS AND FISCAL IMPACT STATEMENT
                (This document is based on the provisions contained in the legislation as of the latest date listed below.)
                               Prepared By: The Professional Staff of the Committee on Rules
BILL:             SB 218
INTRODUCER:       Senator Harrell
SUBJECT:          Genetic Counselors Using Telehealth
DATE:             March 14, 2023                  REVISED:
           ANALYST                      STAFF DIRECTOR                 REFERENCE                                 ACTION
1. Rossitto-Van
                                      Brown                                  HP             Favorable
   Winkle
2. Collazo                            Cibula                                 JU             Favorable
3. Rossitto-Van
                                      Twogood                                RC             Favorable
   Winkle
    I.    Summary:
          SB 218 amends the definition of a telehealth provider in s. 456.47, F.S., to allow licensed genetic
          counselors to provide health care and related services using telehealth.
          The bill provides an effective date of July 1, 2023.
    II.   Present Situation:
          Telehealth
          Section 456.47, F.S., defines the term “telehealth” as the use of synchronous or asynchronous
          telecommunications technology by a telehealth provider to provide health care services,
          including, but not limited to, assessment, diagnosis, consultation, treatment, and monitoring of a
          patient; transfer of medical data; patient and professional health-related education; public health
          services; and health administration. The term does not include audio-only telephone calls, e-mail
          messages, or facsimile transmissions.1
          In a general sense, “synchronous” telehealth happens in live, real-time settings where the patient
          interacts with a provider, usually via phone or video. Providers and patients communicate
          directly, often resulting in a diagnosis, treatment plan, or prescription. Synchronous
          telehealth can include additional at-home devices such as a blood pressure or heart rate monitors,
          thermometers, oximeters, cameras, or scales to help the provider more accurately assess the
          patient’s health status.2
1
 Section 456.47(1)(a), F.S.
2
 TELEHEALTH.HHS.GOV, Synchronous direct-to-consumer telehealth, https://telehealth.hhs.gov/providers/direct-to-
consumer/synchronous-direct-to-consumer-telehealth/ (last visited Mar. 2, 2023).
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         “Asynchronous” telehealth, also known as “store-and-forward,” is often used for patient intake
         or follow-up care. For example, a patient sends a photo of a skin condition that is later reviewed
         by a dermatologist who recommends treatment.3
         Section 456.47, F.S., also authorizes out-of-state health care providers to use telehealth to deliver
         health care services to Florida patients if they register with the applicable board,4 or the
         Department of Health (DOH) if there is no board, and meet certain eligibility requirements.5 A
         registered out-of-state telehealth provider may use telehealth, within the relevant scope of
         practice established by Florida law and rule, to provide health care services to Florida patients,
         but such providers are prohibited from opening an office in Florida, and from providing in-
         person health care services to patients located in Florida, without first becoming licensed by the
         state.6
         A telehealth provider may not use telehealth to prescribe a controlled substance listed in
         Schedule II7 of the state law establishing standards and schedules for controlled substances8
         unless the controlled substance is prescribed for the following:
          The treatment of a psychiatric disorder;
          Inpatient treatment at a licensed hospital;
          The treatment of a patient receiving hospice services;9 or
          The treatment of a resident of a nursing home facility.10, 11
         A telehealth provider must document in the patient’s medical record the health care services
         rendered using telehealth according to the same standard as used for in-person services. Medical
         records, including video, audio, electronic, or other records generated as a result of providing
         such services, are confidential.12
3
  TELEHEALTH.HHS.GOV, Asynchronous direct-to-consumer telehealth, https://telehealth.hhs.gov/providers/direct-to-
consumer/asynchronous-direct-to-consumer-telehealth/ (last visited Mar. 2, 2023).
4
  Under s. 456.001(1), F.S., the term “board” is defined as any board, commission, or other statutorily created entity, to the
extent such entity is authorized to exercise regulatory or rulemaking functions within the DOH or, in some cases, within the
DOH’s Division of Medical Quality Assurance (MQA).
5
  See generally s. 456.47(4), F.S.
6
  See s. 456.47(4)(f), F.S.
7
  Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading
to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II
drugs are: combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine,
methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl,
Dexedrine, Adderall, and Ritalin. U.S. Drug Enforcement Administration, Drug Scheduling, https://www.dea.gov/drug-
information/drug-scheduling (last visited Mar. 2, 2023).
8
  Section 893.03, F.S.
9
  Section 400.601(14). F.S., defines “hospice services” as items and services furnished to a patient and family by a hospice,
or by others under arrangements with such a program, in a place of temporary or permanent residence used as the patient’s
home for the purpose of maintaining the patient at home; or, if the patient needs short-term institutionalization, the services
must be furnished in cooperation with those contracted institutions or in the hospice inpatient facility.
10
   Section 400.021(12), F.S, defines a “nursing home facility” as any facility which provides nursing services defined and
licensed under ch. 464 part I, F.S..
11
   Section 456.47(2)(c), F.S.
12
   Section 456.47(3), F.S. (referencing ss. 395.3025(4) and 456.057, F.S., in connection with confidentiality).
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         The website of an out-of-state telehealth provider registered under s. 456.47, F.S., must
         prominently display a hyperlink to the DOH website, and the DOH website must publish a list of
         all out-of-state registrants and include the following information for each:
          Name.
          Health care occupation.
          Health care training and education, including completion dates and any certificates or
              degrees obtained.
          Out-of-state health care licenses, including license numbers.
          Florida telehealth provider registration number.
          Specialty, if any.
          Board certification, if any.
          Five years of disciplinary history, including sanctions imposed and board actions.
          Medical malpractice insurance provider and policy limits, including whether the policy
              covers claims that arise in Florida.
          The name and address of the registered agent designated for service of process in Florida.13
         A health care professional may not register under s. 456.47, F.S., if his or her license to provide
         health care services is subject to a pending disciplinary investigation or action, or has been
         revoked in any state or jurisdiction. A registered health care professional must notify the
         appropriate board, or the DOH if there is no board, of any restrictions placed on his or her license
         to practice, or any disciplinary action taken or pending against him or her, in any state or
         jurisdiction. This notification must be provided within five business days after the restriction is
         placed or the disciplinary action is initiated or taken.14
         The board, or the DOH if there is no board, may take disciplinary action against an out-of-state
         telehealth provider registered under s. 456.47, F.S., if the registrant:
          Fails to notify the applicable board, or the DOH if there is no board, of any adverse actions
             taken against his or her license;
          Has restrictions placed on, or disciplinary action taken against, his or her license in any state
             or jurisdiction;
          Violates any of the requirements of s. 456.47, F.S.; or
          Commits any act that constitutes grounds for disciplinary action for Florida-licensed
             providers.15
         Disciplinary action taken by the applicable board, or the DOH if there is no board, may include
         suspension or revocation of the provider’s registration, or the issuance of a reprimand or letter of
         concern. A suspension may be accompanied by a corrective action plan as determined by the
         board, or the DOH if there is no board, the completion of which may lead to the suspended
         registration being reinstated according to rules adopted by the board, or the DOH if there is no
         board.16
13
   Section 456.47(4)(c) and (4)(h), F.S.
14
   Section 456.47 (4)(d), F.S.
15
   Section 456.47(4)(i), F.S. (referencing s. 456.072(1), F.S, or the applicable practice act, as the grounds for disciplinary
action).
16
   Id.
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         Venue for civil or administrative actions initiated by the DOH, the appropriate board, or a patient
         who receives telehealth services from an out-of-state telehealth provider may be located in the
         patient’s county of residence or in Leon County.17
         A health care professional who is not licensed to provide health care services in Florida, but who
         holds an active license to provide health care services in another state or jurisdiction, and who
         provides such services using telehealth to a patient located in Florida, is not subject to the
         registration requirement under s. 456.47, F.S., if the services are provided:
          In response to an emergency medical condition; or
          In consultation with a health care professional licensed in Florida who has ultimate authority
             over the diagnosis and care of the patient.18
         Genetic Counselors
         In 2021, the Legislature established a new licensed and regulated practice, genetic counseling,
         within the DOH, in ch. 483, part III, F.S., and authorized the new practice act to be cited as the
         “Genetic Counseling Workforce Act” (Act).19 The Legislature also amended s. 456.001, F.S., to
         include genetic counselors in the definition of “health care practitioner.”20
         The Act provides legislative intent and findings to establish the new health care profession, the
         practice of genetic counseling.21 The Act defines the scope of practice of genetic counseling as a
         process of advising an individual or a family affected by, or at risk of, genetic disorders, to
         include:
          Obtaining and evaluating individual, family, and medical histories to determine the genetic
             risk for genetic or medical conditions and diseases in a patient, his or her offspring, and other
             family members;
          Discussing the features, natural history, means of diagnosis, genetic and environmental
             factors, and management of risk for genetic or medical conditions and diseases;
          Identifying, ordering, and coordinating genetic laboratory tests and other diagnostic studies
             as appropriate for a genetic assessment;
          Integrating genetic laboratory test results and other diagnostic studies with personal and
             family medical history to assess and communicate risk factors for genetic or medical
             conditions and diseases;
          Explaining the clinical implications of genetic laboratory tests and other diagnostic studies
             and their results;
          Evaluating the client’s or family’s responses to the condition or risk of recurrence and
             providing client-centered counseling and anticipatory guidance;
          Identifying and using community resources that provide medical, educational, financial, and
             psychosocial support and advocacy;
17
   Section 456.47(5), F.S.
18
   Section 456.47(6), F.S. (referencing s. 395.002, F.S., in connection with emergency medical conditions).
19
   Ch. 2021-133, Laws of Fla.; ss. 483.911-483.919, F.S. Notably, however, genetic counseling is not listed as one of the
DOH’s divisions or boards in s. 20.43, F.S., pursuant to which the DOH derives its general regulatory authority. See s. 20.43,
F.S.
20
   Ch. 2021-133, s. 2, Laws of Fla.; s. 456.001(4), F.S.
21
   Section 483.912, F.S.
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             Providing written documentation of medical, genetic, and counseling information for families
              and health care professionals; and
             Referring patients to a physician for diagnosis and treatment.22
         A person desiring to be licensed as a genetic counselor must apply to the DOH, and the DOH
         must issue a two-year license to each applicant who:
          Is of good moral character;
          Provides satisfactory documentation of having earned:
            o A master’s degree from a genetic counseling training program or its equivalent as
                determined by the Accreditation Council of Genetic Counseling or its successor or an
                equivalent entity; or
            o A doctoral degree from a medical genetics training program accredited by the American
                Board of Medical Genetics and Genomics or the Canadian College of Medical
                Geneticists.
          Has passed the examination for certification as:
            o A genetic counselor by the American Board of Genetic Counseling, Inc., the American
                Board of Medical Genetics and Genomics, or the Canadian Association of Genetic
                Counsellors; or
            o A medical or clinical geneticist by the American Board of Medical Genetics and
                Genomics or the Canadian College of Medical Geneticists.23
         The Act also establishes grounds for disciplinary action and penalties24 and creates exemptions
         from genetic counseling regulation for:
          Commissioned medical officers of the U.S. Armed Forces or Public Health Service while on
            active duty or while acting within the scope of their military or public health responsibilities;
            and
          Health care practitioners, other than genetic counselors, who are practicing within the scope
            of their education, training, and licensure.25
         The Act includes a “conscience clause” allowing a genetic counselor to refuse to participate in
         counseling that conflicts with his or her deeply held moral or religious beliefs. The license of a
         genetic counselor may not be contingent upon participation in such counseling. A genetic
         counselor’s refusal to participate in counseling that conflicts with his or her deeply held moral or
         religious beliefs may also not form the basis for any claim of damages or for any disciplinary
         action against a genetic counselor, provided:
          The genetic counselor informs the patient that he or she will not participate in such
             counseling; and
          Offers to direct the patient to the online health care practitioner license verification database
             maintained by the DOH.26
22
   Section 483.913(3)(a)-(i), F.S.
23
   Section 483.914(2), F.S.
24
   Section 483.917, F.S.
25
   Section 483.919, F.S. (referencing s. 456.001(4), F.S., for the definition of health care practitioner under state law).
26
   Section 483.918, F.S.
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         Genetic Counseling and Telehealth
         According to the Division of Medical Quality Assurance 2021-2022 Annual Report, since the
         genetic counseling program’s inception, the department has licensed 532 genetic counselors with
         107 (20%) active licensees living in-state and 425 (80%) active licenses living out-of-state.27
         There are 31 states, including Florida, regulating licensure for genetic counselors and 13 states
         with bills in progress. All other states regulating the profession authorize genetic counselors to
         provide telehealth services.28
         The profession of genetic counseling is young compared to other medical specialties. For this
         reason, there are only a few thousand genetic counselors employed in the U.S., which makes
         telehealth a common practice for the profession. Genetic counseling is unique in that evaluating
         a patient’s health and family history with genetic test results could be done almost entirely
         through telehealth services. According to the department, genetic counselors could conceivably
         deliver equally effective services whether someone is in-person or several time zones away.29
III.     Effect of Proposed Changes:
         SB 218 amends the definition of a telehealth provider in s. 456.47, F.S., to include licensed
         genetic counselors so that they may practice their profession using telehealth.
         The bill provides an effective date of July 1, 2023.
IV.      Constitutional Is