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.
44
45 Be It Enacted by the Legislature of the State of Florida:
46
47 Section 1. Section 456.4501, Florida Statutes, is created
48 to read:
49 456.4501 Short 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:
53 456.4502 Definitions.—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:
331 456.4506 Telemedicine 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.