Florida Senate - 2014                             CS for SB 1646
       By the Committees on Communications, Energy, and Public
       Utilities; and Health Policy
       579-03542A-14                                         20141646c1
    1                        A bill to be entitled                      
    2         An act relating to telemedicine; creating s. 456.4501,
    3         F.S.; providing a short title; creating s. 456.4502,
    4         F.S.; defining terms applicable to the act; creating
    5         s. s. 456.4503, F.S.; requiring specified
    6         practitioners providing telemedicine services to
    7         patients in this state to be licensed in this state;
    8         providing certain exceptions for emergency services
    9         and consultations; authorizing nonFlorida licensed
   10         physicians to meet alternative requirements; requiring
   11         pertinent records to be made available upon request;
   12         requiring other health care providers to be supervised
   13         by a telemedicine provider; providing continuing
   14         education requirements for telemedicine providers;
   15         establishing venue; providing applicability;
   16         authorizing the licensing boards to adopt rules;
   17         creating s. 456.4504, F.S.; providing standards and
   18         prohibitions for the provision of telemedicine
   19         services; prohibiting nonemergency prescribing of a
   20         legend drug without a physical examination;
   21         prohibiting the prescription of a controlled substance
   22         for chronic nonmalignant pain using telemedicine;
   23         creating s. 456.4505, F.S.; authorizing the use of
   24         telemedicine services in the diagnosis and treatment
   25         of the human eye; providing requirements for the use
   26         of automated equipment; requiring the owner or lessee
   27         of the automated equipment to maintain specified
   28         liability insurance under certain circumstances;
   29         prohibiting prescriptions for spectacles or contact
   30         lens based solely on the use of an autorefractor;
   31         creating s. 456.4506, F.S.; providing requirements for
   32         reimbursement of telemedicine services under the
   33         Medicaid program; requiring a report to the
   34         Legislature on the usage and costs of telemedicine in
   35         Medicaid by a certain date; providing for future
   36         repeal; amending s. 409.967, F.S.; prohibiting a
   37         managed care plan under Medicaid from using
   38         telemedicine providers that are not physicians;
   39         amending ss. 627.645 and 641.185, F.S.; prohibiting
   40         the denial of a claim for payment for medical services
   41         based on a medical necessity determination conducted
   42         via telemedicine unless the determination is made by a
   43         physician; providing an effective date.
   45  Be It Enacted by the Legislature of the State of Florida:
   47         Section 1. Section 456.4501, Florida Statutes, is created
   48  to read:
   49         456.4501Short title.—Sections 456.4501-456.4506 may be
   50  cited as the “Florida Telemedicine Act.”
   51         Section 2. Section 456.4502, Florida Statutes, is created
   52  to read:
   53         456.4502Definitions.—As used in this act, the term:
   54         (1) “Act” means the Florida Telemedicine Act.
   55         (2) “Advanced communications technology” means:
   56         (a) Compressed digital interactive video, audio, or data
   57  transmissions;
   58         (b) Real-time synchronous video- or web-conferencing
   59  communications;
   60         (c) Secure web-based communications;
   61         (d) Still-image capture or asynchronous store and forward;
   62         (e) Health care service transmissions supported by mobile
   63  devices (mHealth); or
   64         (f) Other technology that facilitates access to health care
   65  services or medical specialty expertise.
   66         (3)“Distant site” means the location at which the
   67  telemedicine provider delivering the health care service is
   68  located at the time the service is provided via telemedicine.
   69         (4) “Encounter” means an examination, consultation,
   70  monitoring, or other health care service.
   71         (5) “Health care provider” means a health care practitioner
   72  or out-of-state licensed individual who provides health care
   73  services within the scope of his or her professional license.
   74         (6) “In person” means that a patient is in the physical
   75  presence of the health care provider without regard to whether
   76  portions of the encounter are conducted by other providers.
   77         (7)“Originating site” means the location of the patient
   78  receiving telemedicine services, which site meets the standards
   79  of this act as verified by the telemedicine provider.
   80         (8)“Patient presenter” means an individual who has
   81  clinical background training in the use of advanced
   82  communications technology equipment and who is available at the
   83  originating site to present the patient, manage the cameras or
   84  equipment, and perform any hands-on activity necessary to
   85  successfully complete the telemedicine encounter under the
   86  direction and supervision of a telemedicine provider.
   87         (9)“Store and forward” means the type of telemedicine
   88  encounter that uses still images of patient data for rendering a
   89  medical opinion or diagnosis. The term includes the asynchronous
   90  transmission of clinical data from one site to another.
   91         (10) “Telehealth” means the use of advanced communications
   92  technology to provide access to health assessment, diagnosis,
   93  intervention, consultation, supervision, and information across
   94  distances. The term includes the use of remote patient
   95  monitoring devices that are used to collect and transmit data
   96  for telemonitoring and interpretation.
   97         (11)“Telemedicine” means the practice of medicine through
   98  the use of advanced communications technology by a telemedicine
   99  provider at a distant site in compliance with federal and state
  100  privacy and confidentiality requirements and encryption
  101  standards. Services provided through telemedicine may include
  102  patient assessment, diagnosis, consultation, treatment,
  103  prescription of medicine, transfer of medical data, or other
  104  medical-related services. The term does not include audio-only
  105  calls, e-mail messages, or facsimile transmissions. Telemedicine
  106  includes telehealth and telemonitoring.
  107         (12) “Telemedicine provider” means a physician or physician
  108  assistant licensed under chapter 458 or chapter 459, an advanced
  109  registered nurse practitioner licensed under chapter 464, or a
  110  pharmacist licensed under chapter 465 who provides telemedicine
  111  services.
  112         Section 3. Section 456.4503, Florida Statutes, is created
  113  to read:
  114         456.4503 Telemedicine requirements.—
  115         (1) An out-of-state physician, physician assistant,
  116  advanced registered nurse practitioner, or pharmacist who
  117  provides telemedicine across state lines to a patient physically
  118  located in this state must have a Florida license to practice as
  119  provided under chapter 458, chapter 459, chapter 464, or chapter
  120  465.
  121         (2) An out-of-state physician, physician assistant,
  122  advanced registered nurse practitioner, or pharmacist is exempt
  123  from subsection (1) if:
  124         (a) The out-of-state physician, physician assistant,
  125  advanced registered nurse practitioner, or pharmacist is
  126  consulting with a telemedicine provider licensed to practice in
  127  this state; and
  128         (b) The telemedicine provider licensed in this state
  129  retains ultimate authority and responsibility for the diagnosis,
  130  treatment, and care of the patient located within this state.
  131         (3) An out-of-state physician is exempt from subsection (1)
  132  if the physician:
  133         (a) Holds an unrestricted active license to practice
  134  allopathic or osteopathic medicine in the state of the distant
  135  site and that state’s licensure requirements must meet or exceed
  136  those of this state under chapter 458 or chapter 459, as
  137  determined by the appropriate board;
  138         (b) Maintains professional liability coverage that includes
  139  coverage for telemedicine services, in an amount and manner
  140  consistent with s. 458.320 and appropriate to the physician’s
  141  scope of practice and location;
  142         (c) Has privileges at or is on the medical staff of an out
  143  of-state hospital affiliated with a Florida hospital licensed
  144  under chapter 395, or has an affiliation with an out-of-state
  145  health insurer or health plan that is also authorized to conduct
  146  business in this state pursuant to chapter 627 or chapter 641;
  147  and
  148         (d) Practices in a state that authorizes Florida-licensed
  149  physicians to provide telemedicine services to patients located
  150  in that state without having to be licensed to practice medicine
  151  in that state.
  152         (4) An out-of-state physician authorized under paragraph
  153  (3) to provide telemedicine services to patients in this state
  154  is subject to appropriate disciplinary action by the Board of
  155  Medicine, the Board of Osteopathic Medicine, or a regulatory
  156  entity in this state which has regulatory jurisdiction over the
  157  hospital, insurer, or health plan affiliated with the physician
  158  as described in subparagraph (3)(c).
  159         (5) A telemedicine provider and a hospital, insurer, or
  160  health plan operating in this state which is affiliated with an
  161  out-of-state physician as described in subparagraph (3)(c) shall
  162  make any pertinent records available upon request of the board,
  163  the department, or other regulatory authority as applicable.
  164  Failure to comply with such request may result in the revocation
  165  of the provider’s license or imposition of a fine by the
  166  applicable board; or, in the case of an affiliated hospital,
  167  insurer, or health plan, a fine, license restriction, or
  168  revocation of an affiliated entity’s authorization to conduct
  169  business in this state.
  170         (6)Consultations that occur on an emergency basis and that
  171  are conducted via telemedicine are exempt from subsection (1).
  172  The terms “emergency services and care and emergency medical
  173  condition have the same meanings as provided in s. 395.002.
  174         (7) A health care provider or patient presenter acting
  175  under the direction and supervision of a telemedicine provider
  176  through the use of telemedicine may not be interpreted as
  177  practicing without a license. However, the health care provider
  178  must be trained in, educated on, and knowledgeable about the
  179  procedure and technology and may not perform duties for which he
  180  or she does not have sufficient training, education, and
  181  knowledge. Failure to have adequate training, education, and
  182  knowledge is grounds for disciplinary action by the appropriate
  183  board, or the department if there is no board, or the affiliated
  184  regulatory entity for affiliated providers.
  185         (8) Upon license renewal, a physician, physician assistant,
  186  advanced registered nurse practitioner, or pharmacist practicing
  187  telemedicine shall:
  188         (a)Designate himself or herself as a telemedicine provider
  189  on the practitioner profile; and
  190         (b) Submit proof of successful completion of a course and
  191  subsequent examination, approved by the board, on the standards
  192  of practice in telemedicine. The course must consist of 2 web
  193  based contact hours. The first course and examination must be
  194  offered by July 1, 2014, and shall be conducted at least
  195  annually thereafter. The course and examination shall be
  196  developed and offered by a statewide professional association
  197  accredited to provide educational activities as designated by
  198  the board. The board shall review and approve the content of the
  199  initial course and examination if the board determines that the
  200  course and examination adequately and reliably satisfy the
  201  criteria set forth in this section. Annually thereafter, the
  202  board shall review the course and examination and, if the board
  203  determines that the content continues to adequately and reliably
  204  satisfy the criteria set forth in this section, approve them.
  205  Successful completion of the board-approved course and
  206  examination may be used to satisfy 2 hours of continuing
  207  education requirements for the biennial period during which the
  208  board-approved course and examination are taken. A physician,
  209  physician assistant, advanced registered nurse practitioner, or
  210  pharmacist who does not complete a board-approved course and
  211  examination under this section may not provide telemedicine
  212  services.
  213         (9) Venue for a civil or administrative action initiated by
  214  the telemedicine recipient, the department, or the appropriate
  215  board shall be based on the location of the patient or shall be
  216  in Leon County.
  217         (10)The boards may adopt rules to administer the
  218  requirements of this act and must repeal rules that are
  219  inconsistent with this act, including rules that prohibit the
  220  use of telemedicine in this state. The appropriate board may
  221  also develop standards and adopt rules relating to requirements
  222  for patient presenters. Such rules may not require the use of
  223  patient presenters in telemedicine services if special skills or
  224  training is not needed for a patient to participate in the
  225  encounter.
  226         Section 4. Section 456.4504, Florida Statutes, is created
  227  to read:
  228         456.4504 Telemedicine standards.—
  229         (1) The standard of care as provided in s. 766.102 is the
  230  same regardless of whether the physician, physician assistant,
  231  advanced registered nurse practitioner, or pharmacist provides
  232  health care services in person or by telemedicine. The
  233  applicable board may adopt rules specifically related to the
  234  standard of care for telemedicine.
  235         (2) A telemedicine provider providing telemedicine services
  236  under this act is responsible for the quality of the equipment
  237  and technology employed and for its safe use. Telemedicine
  238  equipment and advanced communications technology must, at a
  239  minimum, be able to provide the same information to the
  240  telemedicine provider as the information that would be obtained
  241  in an in-person encounter with a health care provider and must
  242  enable the telemedicine provider to meet or exceed the
  243  prevailing standard of care for the practice of the profession.
  244         (3) The telemedicine provider is not required to conduct a
  245  patient history or physical examination of the patient before
  246  engaging in a telemedicine encounter if the telemedicine
  247  provider conducts a patient evaluation sufficient to meet the
  248  prevailing standard of care for the services provided.
  249         (4) Before each telemedicine encounter, the identification
  250  and location of the telemedicine provider and all other
  251  individuals present via advanced communications technology who
  252  will view the patient or the patient’s information must be
  253  identified to the patient.
  254         (5) For the purposes of this act, the nonemergency
  255  prescribing of a legend drug based solely on an electronic
  256  questionnaire without a visual examination is considered a
  257  failure to practice with the level of care, skill, and treatment
  258  which is recognized by a reasonably prudent physician, physician
  259  assistant, advanced registered nurse practitioner, or pharmacist
  260  and is not authorized under this act.
  261         (6) A controlled substance may not be prescribed through
  262  the use of telemedicine for chronic, nonmalignant pain.
  263         (7) Medical records must be kept by each telemedicine
  264  provider that participates in a patient telemedicine encounter
  265  to the same extent as required for an in-person encounter under
  266  state and federal law. Telemedicine providers are encouraged to
  267  create electronic health records to document the encounter and
  268  to transmit information in the most efficient manner possible.
  269         (8) Any medical records generated, including records
  270  maintained via video, audio, electronic, or other means, due to
  271  a telemedicine encounter must conform to the confidentiality and
  272  recordkeeping requirements of federal law and nationally
  273  recognized health care accreditation organizations and the laws
  274  and rules of this state, regardless of where the medical records
  275  of a patient in this state are maintained.
  276         (9) Telemedicine technology used by a telemedicine provider
  277  must be encrypted and must use a recordkeeping program to verify
  278  each interaction.
  279         (10) In those situations in which a telemedicine provider
  280  uses telemedicine technology provided by a third-party vendor,
  281  the telemedicine provider must:
  282         (a) Require a business associate agreement with the third
  283  party vendor; and
  284         (b) Ensure that the third-party vendor complies with the
  285  administrative, physical, and technical safeguards and standards
  286  set forth by the Health Information Technology for Economic and
  287  Clinical Health (HITECH) Act and by federal regulations
  288  implemented pursuant to HITECH.
  289         Section 5. Section 456.4505, Florida Statutes, is created
  290  to read:
  291         456.4505 Telemedicine services to diagnose or treat the
  292  human eye.—
  293         (1)The use of automated equipment, including computer
  294  controlled devices, in the provision of telemedicine services to
  295  diagnose or treat the human eye and its appendages, is
  296  permissible if the following requirements are met at the time
  297  the automated equipment is used:
  298         (a)The automated equipment is approved by the United
  299  States Food and Drug Administration for the intended use;
  300         (b) The automated equipment is designed and operated in a
  301  manner that provides any accommodation required by the federal
  302  ADA Amendments Act of 2008;
  303         (c)The automated equipment and accompanying technology
  304  used for the collection and transmission of information and
  305  data, including photographs and scans, gathers and transmits
  306  protected health information in compliance with the federal
  307  Health Insurance Portability and Accountability Act;
  308         (d)The procedure for which the automated equipment is used
  309  has a recognized Current Procedural Terminology (CPT) code
  310  approved by the Centers for Medicare and Medicaid Services;
  311         (e)The physical location of the automated equipment
  312  prominently displays the name and Florida license number of the
  313  individual who will read and interpret the diagnostic
  314  information and data, including photographs and scans;
  315         (f)Diagnostic information and data, including photographs
  316  and scans, gathered by the automated equipment is read and
  317  interpreted by an optometrist licensed under chapter 463 or a
  318  physician skilled in diseases of the human eye and licensed
  319  under chapter 458 or chapter 459; and
  320         (g)The owner or lessee of the automated equipment
  321  maintains liability insurance in an amount adequate to cover
  322  claims made by individuals diagnosed or treated based on
  323  information and data, including photographs and scans, generated
  324  by the automated equipment.
  325         (2)A prescription for spectacles or contact lens may not
  326  be made based on telemedicine services or based solely on the
  327  refractive error of the human eye generated by a computer
  328  controlled device such as an autorefractor.
  329         Section 6. Section 456.4506, Florida Statutes, is created
  330  to read:
  331         456.4506Telemedicine services under Medicaid.—
  332         (1)The Agency for Health Care Administration shall
  333  reimburse for Medicaid services provided through telemedicine in
  334  the same manner and equivalent to Medicaid services provided in
  335  person under parts III and IV of chapter 409, except as provided
  336  in subsection (7).
  337         (2)Telemedicine services reimbursed under Medicaid must
  338  meet the standards and requirements of this act.
  339         (3)Except as provided in subsection (7), the agency may
  340  not require in-person contact between a telemedicine provider
  341  and Medicaid recipient as a prerequisite for payment for
  342  services appropriately provided through telemedicine in
  343  accordance with generally accepted health care practices and
  344  standards prevailing in the applicable health care community at
  345  the time the services are provided.
  346         (4) Before receipt of telemedicine services, a Medicaid
  347  recipient or the legal representative of a Medicaid recipient
  348  must provide informed consent for telemedicine services. A
  349  Medicaid recipient shall also be provided the opportunity to
  350  receive the same service through an in-person encounter.
  351         (5)A Medicaid service that is provided through a fee-for
  352  service or managed care program may not be denied as a
  353  creditable Medicaid service solely because that service is
  354  provided through telemedicine.
  355         (6)Reimbursement of telemedicine services under Medicaid
  356  shall be the amount negotiated between the parties involved to
  357  the extent permitted under state and federal law. Regardless of
  358  the reimbursement methodology or amount, telemedicine providers
  359  located at the originating site and the distant site should both
  360  receive reimbursement based on the services rendered, if any,
  361  during the telemedicine encounter.
  362         (7)If, after implementation, the agency determines that
  363  the delivery of a particular service through telemedicine is not
  364  cost-effective or does not adequately meet the clinical needs of
  365  recipients and the determination has been documented, the agency
  366  may discontinue Medicaid reimbursement for that telemedicine
  367  service.
  368         (8)The agency shall submit a report on the usage and
  369  costs, including savings, if any, associated with the provision
  370  of health care services through telemedicine under the Medicaid
  371  program by January 1, 2017, to the President of the Senate, the
  372  Speaker of the House of Representatives, and the minority
  373  leaders of the Senate and the House of Representatives.
  374         (9)This section is repealed June 30, 2017.
  375         Section 7. Paragraph (c) of subsection (2) of section
  376  409.967, Florida Statutes, is amended to read:
  377         409.967 Managed care plan accountability.—
  378         (2) The agency shall establish such contract requirements
  379  as are necessary for the operation of the statewide managed care
  380  program. In addition to any other provisions the agency may deem
  381  necessary, the contract must require:
  382         (c) Access.—
  383         1. The agency shall establish specific standards for the
  384  number, type, and regional distribution of providers in managed
  385  care plan networks to ensure access to care for both adults and
  386  children. Each plan must maintain a regionwide network of
  387  providers in sufficient numbers to meet the access standards for
  388  specific medical services for all recipients enrolled in the
  389  plan. A plan may not use telemedicine providers as defined in s.
  390  456.4502 to meet this requirement unless the provider is
  391  licensed under chapter 458 or chapter 459. The exclusive use of
  392  mail-order pharmacies may not be sufficient to meet network
  393  access standards. Consistent with the standards established by
  394  the agency, provider networks may include providers located
  395  outside the region. A plan may contract with a new hospital
  396  facility before the date the hospital becomes operational if the
  397  hospital has commenced construction, will be licensed and
  398  operational by January 1, 2013, and a final order has issued in
  399  any civil or administrative challenge. Each plan shall establish
  400  and maintain an accurate and complete electronic database of
  401  contracted providers, including information about licensure or
  402  registration, locations and hours of operation, specialty
  403  credentials and other certifications, specific performance
  404  indicators, and such other information as the agency deems
  405  necessary. The database must be available online to both the
  406  agency and the public and have the capability to compare the
  407  availability of providers to network adequacy standards and to
  408  accept and display feedback from each provider’s patients. Each
  409  plan shall submit quarterly reports to the agency identifying
  410  the number of enrollees assigned to each primary care provider.
  411         2. Each managed care plan must publish any prescribed drug
  412  formulary or preferred drug list on the plan’s website in a
  413  manner that is accessible to and searchable by enrollees and
  414  providers. The plan must update the list within 24 hours after
  415  making a change. Each plan must ensure that the prior
  416  authorization process for prescribed drugs is readily accessible
  417  to health care providers, including posting appropriate contact
  418  information on its website and providing timely responses to
  419  providers. For Medicaid recipients diagnosed with hemophilia who
  420  have been prescribed anti-hemophilic-factor replacement
  421  products, the agency shall provide for those products and
  422  hemophilia overlay services through the agency’s hemophilia
  423  disease management program.
  424         3. Managed care plans, and their fiscal agents or
  425  intermediaries, must accept prior authorization requests for any
  426  service electronically.
  427         Section 8. Subsection (3) is added to section 627.645,
  428  Florida Statutes, to read:
  429         627.645 Denial of health insurance claims restricted.—
  430         (3) A claim for payment under a health insurance policy for
  431  medical care or treatment may not be denied on the basis of a
  432  medical necessity determination conducted via telemedicine as
  433  defined in s. 456.4502 unless the determination is made by a
  434  physician licensed under chapter 458 or chapter 459.
  435         Section 9. Paragraph (m) is added to subsection (1) of
  436  section 641.185, Florida Statutes, to read:
  437         641.185 Health maintenance organization subscriber
  438  protections.—
  439         (1) With respect to the provisions of this part and part
  440  III, the principles expressed in the following statements shall
  441  serve as standards to be followed by the commission, the office,
  442  the department, and the Agency for Health Care Administration in
  443  exercising their powers and duties, in exercising administrative
  444  discretion, in administrative interpretations of the law, in
  445  enforcing its provisions, and in adopting rules:
  446         (m) A health maintenance organization may not deny a claim
  447  for payment for medical care or treatment on the basis of a
  448  medical necessity determination conducted via telemedicine as
  449  defined in s. 456.4502 unless the determination is made by a
  450  physician licensed under chapter 458 or chapter 459.
  451         Section 10. This act shall take effect October 1, 2014.