Florida Senate - 2021                              CS for SB 700
       
       
        
       By the Committee on Health Policy; and Senator Rodriguez
       
       
       
       
       
       588-02182-21                                           2021700c1
    1                        A bill to be entitled                      
    2         An act relating to telehealth; amending s. 409.908,
    3         F.S.; requiring the Agency for Health Care
    4         Administration to reimburse the use of telehealth
    5         services under certain circumstances and subject to
    6         certain limitations; requiring providers to include
    7         certain documentation in patient records and notes;
    8         authorizing certain out-of-state providers to receive
    9         reimbursement for telehealth services; providing an
   10         exception; amending s. 456.47, F.S.; revising the
   11         definition of the term “telehealth”; authorizing
   12         telehealth providers to prescribe specified controlled
   13         substances through telehealth under certain
   14         circumstances; authorizing nonphysician health care
   15         practitioners to satisfy a certain supervision
   16         requirement through telehealth; amending ss. 458.347
   17         and 459.022, F.S.; revising the definition of the term
   18         “supervision”; amending s. 465.003, F.S.; revising the
   19         definition of the term “pharmacy”; revising
   20         construction of the term “not present and on duty”;
   21         amending s. 465.014, F.S.; authorizing registered
   22         pharmacy technicians to compound and dispense
   23         medicinal drugs under certain circumstances; providing
   24         an exception to certain supervision limitations;
   25         amending s. 465.015, F.S.; providing applicability;
   26         exempting certain registered pharmacy technicians from
   27         specified prohibitions; creating s. 465.0198, F.S.;
   28         defining the term “supervising pharmacy”; providing
   29         for the permitting of remote-site pharmacies;
   30         requiring a licensed or consultant pharmacist to serve
   31         as the prescription department manager of a remote
   32         site; requiring remote-site pharmacies to notify the
   33         Department of Health of a change in the pharmacy’s
   34         prescription department manager within a specified
   35         timeframe; providing requirements for remote-site
   36         pharmacies; providing that remote-site pharmacies are
   37         not considered pharmacy locations for purposes of
   38         network access in managed care programs; authorizing
   39         remote-site pharmacies to store, hold, and dispense
   40         medicinal drugs; prohibiting remote-site pharmacies
   41         from performing centralized prescription filling;
   42         requiring prescription department managers to visit
   43         remote sites, based on a certain schedule, to perform
   44         specified tasks; authorizing registered pharmacists to
   45         serve as prescription department managers for up to
   46         three remote-site pharmacies under certain
   47         circumstances; amending s. 465.022, F.S.; exempting
   48         registered pharmacists serving as prescription
   49         department managers for remote-site pharmacies from
   50         certain practice limitations; amending s. 465.0265,
   51         F.S.; providing applicability; amending s. 465.1893,
   52         F.S.; providing additional long-acting medications
   53         pharmacists may administer under certain
   54         circumstances; revising requirements for a continuing
   55         education course such pharmacists must complete;
   56         amending s. 468.1225, F.S.; revising minimum
   57         procedures and equipment requirements for fitting and
   58         selling hearing aids; amending s. 468.1265, F.S.;
   59         revising a prohibition on the sale or distribution of
   60         hearing aids through the mail; amending s. 484.0501,
   61         F.S.; revising minimum procedures and equipment
   62         requirements for fitting and selling hearing aids;
   63         amending s. 484.054, F.S.; revising a prohibition on
   64         the sale or distribution of hearing aids through the
   65         mail; amending s. 893.05, F.S.; prohibiting telehealth
   66         providers from prescribing specified controlled
   67         substances through telehealth; providing an effective
   68         date.
   69          
   70  Be It Enacted by the Legislature of the State of Florida:
   71  
   72         Section 1. Present subsections (22) through (26) of section
   73  409.908, Florida Statutes, are redesignated as subsections (23)
   74  through (27), respectively, and a new subsection (22) is added
   75  to that section, to read:
   76         409.908 Reimbursement of Medicaid providers.—Subject to
   77  specific appropriations, the agency shall reimburse Medicaid
   78  providers, in accordance with state and federal law, according
   79  to methodologies set forth in the rules of the agency and in
   80  policy manuals and handbooks incorporated by reference therein.
   81  These methodologies may include fee schedules, reimbursement
   82  methods based on cost reporting, negotiated fees, competitive
   83  bidding pursuant to s. 287.057, and other mechanisms the agency
   84  considers efficient and effective for purchasing services or
   85  goods on behalf of recipients. If a provider is reimbursed based
   86  on cost reporting and submits a cost report late and that cost
   87  report would have been used to set a lower reimbursement rate
   88  for a rate semester, then the provider’s rate for that semester
   89  shall be retroactively calculated using the new cost report, and
   90  full payment at the recalculated rate shall be effected
   91  retroactively. Medicare-granted extensions for filing cost
   92  reports, if applicable, shall also apply to Medicaid cost
   93  reports. Payment for Medicaid compensable services made on
   94  behalf of Medicaid eligible persons is subject to the
   95  availability of moneys and any limitations or directions
   96  provided for in the General Appropriations Act or chapter 216.
   97  Further, nothing in this section shall be construed to prevent
   98  or limit the agency from adjusting fees, reimbursement rates,
   99  lengths of stay, number of visits, or number of services, or
  100  making any other adjustments necessary to comply with the
  101  availability of moneys and any limitations or directions
  102  provided for in the General Appropriations Act, provided the
  103  adjustment is consistent with legislative intent.
  104         (22) Subject to any limitations or directions provided in
  105  the General Appropriations Act, the agency shall reimburse the
  106  use of telehealth as defined by s. 456.47, to include services
  107  provided in real time, services provided using store-and-forward
  108  technologies, and remote patient monitoring services to the
  109  extent that these technologies are available.
  110         (a)Providers using any modality described in this
  111  subsection must ensure that treatment services are medically
  112  necessary and performed within a provider’s scope of practice
  113  and any applicable supervision requirements.
  114         (b)Providers must include documentation regarding the use
  115  of telehealth in the medical record or progress notes for each
  116  encounter with a recipient.
  117         (c)Out-of-state providers who are registered under s.
  118  456.47(4) and enrolled in Florida Medicaid as an out-of-state
  119  provider may be reimbursed for telehealth services provided to
  120  recipients in this state.
  121         (d)Reimbursement under this subsection does not cover the
  122  purchase of any general telecommunications equipment that is not
  123  specific to or used solely for the provision of telehealth,
  124  including, but not limited to, computers, tablets, cell phones,
  125  smartphones, or any other similar equipment or device.
  126         Section 2. Paragraph (a) of subsection (1) and paragraph
  127  (c) of subsection (2) of section 456.47, Florida Statutes, are
  128  amended, and paragraph (f) is added to subsection (2) of that
  129  section, to read:
  130         456.47 Use of telehealth to provide services.—
  131         (1) DEFINITIONS.—As used in this section, the term:
  132         (a) “Telehealth” means the use of synchronous or
  133  asynchronous telecommunications technology by a telehealth
  134  provider to provide or supervise the provision of health care
  135  services, including, but not limited to, assessment, diagnosis,
  136  consultation, treatment, and monitoring of a patient; transfer
  137  of medical data; patient and professional health-related
  138  education; public health services; and health administration.
  139  The term includes does not include audio-only telephone calls,
  140  personal e-mail messages, or facsimile transmissions, and any
  141  other nonpublic-facing telecommunications technology.
  142         (2) PRACTICE STANDARDS.—
  143         (c) A telehealth provider, acting within the scope of his
  144  or her practice and in accordance with chapter 893, may not use
  145  telehealth to prescribe a controlled substance listed in
  146  Schedule III, Schedule IV, or Schedule V of s. 893.03 unless the
  147  controlled substance is prescribed for the following:
  148         1. The treatment of a psychiatric disorder;
  149         2. Inpatient treatment at a hospital licensed under chapter
  150  395;
  151         3. The treatment of a patient receiving hospice services as
  152  defined in s. 400.601; or
  153         4. The treatment of a resident of a nursing home facility
  154  as defined in s. 400.021.
  155         (f)A nonphysician health care practitioner, including, but
  156  not limited to, an advanced practice registered nurse, a
  157  certified registered nurse anesthetist, or a physician
  158  assistant, who is required to maintain a formal supervisory
  159  relationship with a physician may satisfy such requirement
  160  through telehealth.
  161         Section 3. Paragraph (f) of subsection (2) of section
  162  458.347, Florida Statutes, is amended to read:
  163         458.347 Physician assistants.—
  164         (2) DEFINITIONS.—As used in this section:
  165         (f) “Supervision” means responsible supervision and
  166  control. Except in cases of emergency, supervision requires the
  167  easy availability or physical presence of the licensed physician
  168  for consultation and direction of the actions of the physician
  169  assistant. For the purposes of this definition, the term “easy
  170  availability” includes the ability to communicate by way of
  171  telehealth as defined in s. 456.47(1) telecommunication. The
  172  boards shall establish rules as to what constitutes responsible
  173  supervision of the physician assistant.
  174         Section 4. Paragraph (f) of subsection (2) of section
  175  459.022, Florida Statutes, is amended to read:
  176         459.022 Physician assistants.—
  177         (2) DEFINITIONS.—As used in this section:
  178         (f) “Supervision” means responsible supervision and
  179  control. Except in cases of emergency, supervision requires the
  180  easy availability or physical presence of the licensed physician
  181  for consultation and direction of the actions of the physician
  182  assistant. For the purposes of this definition, the term “easy
  183  availability” includes the ability to communicate by way of
  184  telehealth as defined in s. 456.47(1) telecommunication. The
  185  boards shall establish rules as to what constitutes responsible
  186  supervision of the physician assistant.
  187         Section 5. Subsection (11) of section 465.003, Florida
  188  Statutes, is amended to read:
  189         465.003 Definitions.—As used in this chapter, the term:
  190         (11)(a) “Pharmacy” includes a community pharmacy, an
  191  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
  192  and an Internet pharmacy, and a remote-site pharmacy.
  193         1. The term “community pharmacy” includes every location
  194  where medicinal drugs are compounded, dispensed, stored, or sold
  195  or where prescriptions are filled or dispensed on an outpatient
  196  basis.
  197         2. The term “institutional pharmacy” includes every
  198  location in a hospital, clinic, nursing home, dispensary,
  199  sanitarium, extended care facility, or other facility,
  200  hereinafter referred to as “health care institutions,” where
  201  medicinal drugs are compounded, dispensed, stored, or sold.
  202         3. The term “nuclear pharmacy” includes every location
  203  where radioactive drugs and chemicals within the classification
  204  of medicinal drugs are compounded, dispensed, stored, or sold.
  205  The term “nuclear pharmacy” does not include hospitals licensed
  206  under chapter 395 or the nuclear medicine facilities of such
  207  hospitals.
  208         4. The term “special pharmacy” includes every location
  209  where medicinal drugs are compounded, dispensed, stored, or sold
  210  if such locations are not otherwise defined in this subsection.
  211         5. The term “Internet pharmacy” includes locations not
  212  otherwise licensed or issued a permit under this chapter, within
  213  or outside this state, which use the Internet to communicate
  214  with or obtain information from consumers in this state and use
  215  such communication or information to fill or refill
  216  prescriptions or to dispense, distribute, or otherwise engage in
  217  the practice of pharmacy in this state. Any act described in
  218  this definition constitutes the practice of pharmacy as defined
  219  in subsection (13).
  220         6.The term “remote-site pharmacy” or “remote site”
  221  includes every location where medicinal drugs are compounded or
  222  dispensed by a registered pharmacy technician who is remotely
  223  supervised by an off-site pharmacist acting in the capacity of a
  224  prescription department manager.
  225         (b) The pharmacy department of any permittee shall be
  226  considered closed whenever a Florida licensed pharmacist is not
  227  present and on duty. The term “not present and on duty” may
  228  shall not be construed to prevent any of the following:
  229         1. A pharmacist from exiting the prescription department
  230  for the purposes of consulting or responding to inquiries or
  231  providing assistance to patients or customers.
  232         2.A pharmacist from, attending to personal hygiene needs.
  233         3.A pharmacist from, or performing any other function for
  234  which the pharmacist is responsible, provided that such
  235  activities are conducted in a manner consistent with the
  236  pharmacist’s responsibility to provide pharmacy services.
  237         4.An off-site pharmacist, acting in the capacity of a
  238  prescription department manager, from remotely supervising a
  239  registered pharmacy technician at a remote-site pharmacy.
  240         Section 6. Subsection (1) of section 465.014, Florida
  241  Statutes, is amended to read:
  242         465.014 Pharmacy technician.—
  243         (1) A person other than a licensed pharmacist or pharmacy
  244  intern may not engage in the practice of the profession of
  245  pharmacy, except that a licensed pharmacist may delegate to
  246  pharmacy technicians who are registered pursuant to this section
  247  those duties, tasks, and functions that do not fall within the
  248  purview of s. 465.003(13), and a registered pharmacy technician
  249  operating under remote supervision of an off-site pharmacist
  250  under s. 465.0198 may compound and dispense medicinal drugs
  251  under such supervision. All such delegated acts must be
  252  performed under the direct supervision of a licensed pharmacist
  253  who is responsible for all such acts performed by persons under
  254  his or her supervision. A registered pharmacy technician, under
  255  the supervision of a pharmacist, may initiate or receive
  256  communications with a practitioner or his or her agent, on
  257  behalf of a patient, regarding refill authorization requests. A
  258  licensed pharmacist may not supervise more than one registered
  259  pharmacy technician, except as provided in s. 465.0198 or unless
  260  otherwise permitted by the guidelines adopted by the board. The
  261  board shall establish guidelines to be followed by licensees or
  262  permittees in determining the circumstances under which a
  263  licensed pharmacist may supervise more than one pharmacy
  264  technician.
  265         Section 7. Paragraph (b) of subsection (1) and paragraph
  266  (b) of subsection (2) of section 465.015, Florida Statutes, are
  267  amended to read:
  268         465.015 Violations and penalties.—
  269         (1) It is unlawful for any person to own, operate,
  270  maintain, open, establish, conduct, or have charge of, either
  271  alone or with another person or persons, a pharmacy:
  272         (b) In which a person not licensed as a pharmacist in this
  273  state or not registered as an intern in this state or in which
  274  an intern who is not acting under the direct and immediate
  275  personal supervision of a licensed pharmacist fills, compounds,
  276  or dispenses any prescription or dispenses medicinal drugs. This
  277  paragraph does not apply to any person who owns, operates,
  278  maintains, opens, establishes, conducts, or has charge of a
  279  remote site pursuant to s. 465.0198.
  280         (2) It is unlawful for any person:
  281         (b) To fill, compound, or dispense prescriptions or to
  282  dispense medicinal drugs if such person does not hold an active
  283  license as a pharmacist in this state, is not registered as an
  284  intern in this state, or is an intern not acting under the
  285  direct and immediate personal supervision of a licensed
  286  pharmacist, or is not a registered pharmacy technician at a
  287  remote-site pharmacy acting under remote supervision of a
  288  licensed pharmacist pursuant to s. 465.0198.
  289         Section 8. Section 465.0198, Florida Statutes, is created
  290  to read:
  291         465.0198 Remote-site pharmacy permits.—
  292         (1)As used in this section, the term “supervising
  293  pharmacy” means a pharmacy licensed in this state which employs
  294  a licensed pharmacist who remotely supervises a registered
  295  pharmacy technician at a remote-site pharmacy.
  296         (2)Any person desiring a permit to operate a remote-site
  297  pharmacy must apply to the department. If the board certifies
  298  that the application complies with the laws and rules of the
  299  board, the department must issue the permit. A permit may not be
  300  issued unless a licensed pharmacist or consultant pharmacist is
  301  designated as the prescription department manager responsible
  302  for the oversight of the remote site. The permittee must notify
  303  the department within 10 days after any change of the
  304  prescription department manager.
  305         (3)A remote-site pharmacy must comply with all of the
  306  following:
  307         (a)Be jointly owned by or operated under a contract with a
  308  supervising pharmacy.
  309         (b)Maintain a video surveillance system that records
  310  continuously 24 hours per day and retain video surveillance
  311  recordings for at least 45 days.
  312         (c)Display a sign visible to the public indicating that
  313  the location is a remote-site pharmacy and that the facility is
  314  under 24-hour video surveillance.
  315         (d)Maintain a policies and procedures manual, which must
  316  be made available to the board or its agent upon request, and
  317  must include, but need not be limited to, all of the following:
  318         1.A description of how the pharmacy will comply with
  319  federal and state laws and rules.
  320         2.The procedures for supervising the remote site and
  321  counseling its patients.
  322         3.The procedures for reviewing the prescription drug
  323  inventory and drug records maintained by the remote site.
  324         4.The policies and procedures for providing security
  325  adequate to protect the confidentiality and integrity of patient
  326  information.
  327         5.The written plan for recovery from an event that
  328  interrupts or prevents the prescription department manager from
  329  supervising the remote site’s operation.
  330         6.The procedures for use of the state prescription drug
  331  monitoring program by the prescription department manager before
  332  he or she may authorize the dispensing of any controlled
  333  substance.
  334         7.The procedures for maintaining a perpetual inventory of
  335  the controlled substances listed in s. 893.03(2).
  336         8.The specific duties, tasks, and functions that
  337  registered pharmacy technicians are authorized to perform at the
  338  remote site.
  339         (4)A remote-site pharmacy is not considered a pharmacy
  340  location for purposes of network access in managed care
  341  programs.
  342         (5)A remote-site pharmacy may store, hold, or dispense any
  343  medicinal drug.
  344         (6)A remote-site pharmacy may not perform centralized
  345  prescription filling as defined in s. 465.003(16).
  346         (7)The prescription department manager must visit the
  347  remote site, based on a schedule determined by the board, to
  348  inspect the pharmacy, address personnel matters, and provide
  349  clinical services for patients.
  350         (8)A registered pharmacist may serve as the prescription
  351  department manager for up to three remote-site pharmacies that
  352  are under common control of the same supervising pharmacy.
  353         Section 9. Paragraph (c) of subsection (11) of section
  354  465.022, Florida Statutes, is amended to read:
  355         465.022 Pharmacies; general requirements; fees.—
  356         (11) A permittee must notify the department of the identity
  357  of the prescription department manager within 10 days after
  358  employment. The prescription department manager must comply with
  359  the following requirements:
  360         (c) A registered pharmacist may not serve as the
  361  prescription department manager in more than one location,
  362  except as authorized under s. 465.0198, unless approved by the
  363  board.
  364         Section 10. Subsection (1) of section 465.0265, Florida
  365  Statutes, is amended to read:
  366         465.0265 Centralized prescription filling.—
  367         (1) A pharmacy licensed under this chapter may perform
  368  centralized prescription filling for another pharmacy, provided
  369  that the pharmacies have the same owner or have a written
  370  contract specifying the services to be provided by each
  371  pharmacy, the responsibilities of each pharmacy, and the manner
  372  in which the pharmacies will comply with federal and state laws,
  373  rules, and regulations. This subsection does not apply to a
  374  remote-site pharmacy.
  375         Section 11. Section 465.1893, Florida Statutes, is amended
  376  to read
  377         465.1893 Administration of long-acting antipsychotic
  378  medication by injection.—
  379         (1)(a) A pharmacist, at the direction of a physician
  380  licensed under chapter 458 or chapter 459, may administer a
  381  long-acting antipsychotic medication or an extended-release
  382  medication indicated to treat opioid use disorder, alcohol use
  383  disorder, or other substance use disorder or dependency,
  384  including, but not limited to, buprenorphine, naltrexone, or
  385  other medications that have been approved by the United States
  386  Food and Drug Administration by injection to a patient if the
  387  pharmacist:
  388         1. Is authorized by and acting within the framework of an
  389  established protocol with the prescribing physician.
  390         2. Practices at a facility that accommodates privacy for
  391  nondeltoid injections and conforms with state rules and
  392  regulations regarding the appropriate and safe disposal of
  393  medication and medical waste.
  394         3. Has completed the course required under subsection (2).
  395         (b) A separate prescription from a physician is required
  396  for each injection administered by a pharmacist under this
  397  subsection.
  398         (2)(a) A pharmacist seeking to administer a long-acting
  399  antipsychotic medication described in paragraph (1)(a) by
  400  injection must complete an 8-hour continuing education course
  401  offered by:
  402         1. A statewide professional association of physicians in
  403  this state accredited to provide educational activities
  404  designated for the American Medical Association Physician’s
  405  Recognition Award (AMA PRA) Category 1 Credit or the American
  406  Osteopathic Association (AOA) Category 1-A continuing medical
  407  education (CME) credit; and
  408         2. A statewide association of pharmacists.
  409         (b) The course may be offered in a distance learning format
  410  and must be included in the 30 hours of continuing professional
  411  pharmaceutical education required under s. 465.009(1). The
  412  course shall have a curriculum of instruction that concerns the
  413  safe and effective administration of behavioral health,
  414  addiction, and antipsychotic medications by injection,
  415  including, but not limited to, potential allergic reactions to
  416  such medications.
  417         Section 12. Subsections (1) through (4) of section
  418  468.1225, Florida Statutes, are amended to read:
  419         468.1225 Procedures, equipment, and protocols.—
  420         (1) The following minimal procedures must shall be used
  421  when a licensed audiologist fits and sells a hearing aid unless
  422  the client is 18 years of age or older and provides a medical
  423  clearance or a waiver of medical examination:
  424         (a) Pure tone audiometric testing by air and bone to
  425  determine the type and degree of hearing deficiency when
  426  indicated.
  427         (b) Effective masking when indicated.
  428         (c) Appropriate testing to determine speech reception
  429  thresholds, speech discrimination scores, the most comfortable
  430  listening levels, uncomfortable loudness levels, and the
  431  selection of the best fitting arrangement for maximum hearing
  432  aid benefit when indicated.
  433         (2) The following equipment must shall be used unless the
  434  client is 18 years of age or older and provides a medical
  435  clearance or a waiver of medical examination:
  436         (a) A wide range audiometer that which meets the
  437  specifications of the American National Standards Institute for
  438  diagnostic audiometers when indicated.
  439         (b) A speech audiometer or a master hearing aid in order to
  440  determine the most comfortable listening level and speech
  441  discrimination when indicated.
  442         (3) A final fitting ensuring physical and operational
  443  comfort of the hearing aid must shall be made when indicated.
  444         (4) A licensed audiologist who fits and sells hearing aids
  445  must shall obtain the following medical clearance: If, upon
  446  inspection of the ear canal with an otoscope in the common
  447  procedure of fitting a hearing aid or and upon interrogation of
  448  the client, there is any recent history of infection or any
  449  observable anomaly, the client must shall be instructed to see a
  450  physician, and a hearing aid may shall not be fitted until
  451  medical clearance is obtained for the condition noted. If, upon
  452  return, the condition noted is no longer observable and the
  453  client signs a medical waiver, a hearing aid may be fitted. Any
  454  person with a significant difference between bone conduction
  455  hearing and air conduction hearing must be informed of the
  456  possibility of medical or surgical correction.
  457         Section 13. Section 468.1265, Florida Statutes, is amended
  458  to read:
  459         468.1265 Sale or distribution of hearing aids through mail;
  460  penalty.—It is unlawful for any person to sell or distribute
  461  hearing aids through the mail to the ultimate consumer who is
  462  younger than 18 years of age. Any person who violates this
  463  section commits a misdemeanor of the second degree, punishable
  464  as provided in s. 775.082 or s. 775.083.
  465         Section 14. Subsections (1) through (4) of section
  466  484.0501, Florida Statutes, are amended to read:
  467         484.0501 Minimal procedures and equipment.—
  468         (1) The following minimal procedures must shall be used in
  469  the fitting and selling of hearing aids unless the client is 18
  470  years of age or older and provides a medical clearance or a
  471  waiver of medical examination:
  472         (a) Pure tone audiometric testing by air and bone to
  473  determine the type and degree of hearing deficiency.
  474         (b) Effective masking when indicated.
  475         (c) Appropriate testing to determine speech reception
  476  thresholds, speech discrimination scores, the most comfortable
  477  listening levels, uncomfortable loudness levels, and the
  478  selection of the best fitting arrangement for maximum hearing
  479  aid benefit.
  480         (2) The following equipment must shall be used unless the
  481  client is 18 years of age or older and provides a medical
  482  clearance or a waiver of medical examination:
  483         (a) A wide range audiometer that which meets the
  484  specifications of the American National Standards Institute for
  485  diagnostic audiometers.
  486         (b) A speech audiometer or a master hearing aid in order to
  487  determine the most comfortable listening level and speech
  488  discrimination.
  489         (3) For clients younger than 18 years of age, a final
  490  fitting ensuring physical and operational comfort of the hearing
  491  aid must shall be made. For all other clients, such final
  492  fitting must be made when indicated.
  493         (4) The following medical clearance must shall be obtained:
  494  If, upon inspection of the ear canal with an otoscope in the
  495  common procedure of a hearing aid fitter or and upon
  496  interrogation of the client, there is any recent history of
  497  infection or any observable anomaly, the client must shall be
  498  instructed to see a physician, and a hearing aid may shall not
  499  be fitted until medical clearance is obtained for the condition
  500  noted. If, upon return, the condition noted is no longer
  501  observable and the client signs a medical waiver, a hearing aid
  502  may be fitted. Any person with a significant difference between
  503  bone conduction hearing and air conduction hearing must be
  504  informed of the possibility of medical correction.
  505         Section 15. Section 484.054, Florida Statutes, is amended
  506  to read:
  507         484.054 Sale or distribution of hearing aids through mail;
  508  penalty.—It is unlawful for any person to sell or distribute
  509  hearing aids through the mail to the ultimate consumer who is
  510  younger than 18 years of age. Any violation of this section
  511  constitutes a misdemeanor of the second degree, punishable as
  512  provided in s. 775.082 or s. 775.083.
  513         Section 16. Paragraph (e) is added to subsection (1) of
  514  section 893.05, Florida Statutes, to read:
  515         893.05 Practitioners and persons administering controlled
  516  substances in their absence.—
  517         (1)
  518         (e) A telehealth provider as defined in s. 456.47 may not
  519  prescribe through telehealth a controlled substance listed in
  520  Schedule I or Schedule II of s. 893.03.
  521         Section 17. This act shall take effect July 1, 2021.