Florida Senate - 2014 COMMITTEE AMENDMENT Bill No. CS for SB 1646 Ì449942@Î449942 LEGISLATIVE ACTION Senate . House Comm: UNFAV . 04/11/2014 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 456.4501, Florida Statutes, is created 6 to read: 7 456.4501 Short title.—Sections 456.4501-456.4506 may be 8 cited as the “Florida Telemedicine Act.” 9 Section 2. Section 456.4502, Florida Statutes, is created 10 to read: 11 456.4502 Definitions.—As used in this act, the term: 12 (1) “Act” means the Florida Telemedicine Act. 13 (2) “Advanced communications technology” means: 14 (a) Compressed digital interactive video, audio, or data 15 transmissions; 16 (b) Real-time synchronous video- or web-conferencing 17 communications; 18 (c) Secure web-based communications; 19 (d) Still-image capture or asynchronous store and forward; 20 (e) Health care service transmissions supported by mobile 21 devices (mHealth); or 22 (f) Other technology that facilitates access to health care 23 services or medical specialty expertise. 24 (3) “Distant site” means the location at which the 25 telemedicine provider delivering the health care service is 26 located at the time the service is provided via telemedicine. 27 (4) “Encounter” means an examination, consultation, 28 monitoring, or other health care service. 29 (5) “Health care provider” means a health care practitioner 30 or out-of-state licensed individual who provides health care 31 services within the scope of his or her professional license. 32 (6) “In person” means that a patient is in the physical 33 presence of the health care provider without regard to whether 34 portions of the encounter are conducted by other providers. 35 (7) “Originating site” means the location of the patient 36 receiving telemedicine services, which site meets the standards 37 of this act as verified by the telemedicine provider. 38 (8) “Patient presenter” means an individual who has 39 clinical background training in the use of advanced 40 communications technology equipment and who is available at the 41 originating site to present the patient, manage the cameras or 42 equipment, and perform any hands-on activity necessary to 43 successfully complete the telemedicine encounter under the 44 direction and supervision of a telemedicine provider. 45 (9) “Store and forward” means the type of telemedicine 46 encounter that uses still images of patient data for rendering a 47 medical opinion or diagnosis. The term includes the asynchronous 48 transmission of clinical data from one site to another. 49 (10) “Telehealth” means the use of advanced communications 50 technology to provide access to health assessment, diagnosis, 51 intervention, consultation, supervision, and information across 52 distances. The term includes the use of remote patient 53 monitoring devices that are used to collect and transmit data 54 for telemonitoring and interpretation. 55 (11) “Telemedicine” means the use of advanced 56 communications technology by a telemedicine provider at a 57 distant or originating site in compliance with federal and state 58 privacy and confidentiality requirements and encryption 59 standards. Services provided through telemedicine may include 60 patient assessment, diagnosis, consultation, treatment, 61 prescription of medicine, transfer of medical data, or other 62 medical-related services. The term does not include audio-only 63 calls, e-mail messages, or facsimile transmissions. Telemedicine 64 includes telehealth and telemonitoring. 65 (12) “Telemedicine provider” means a health care 66 practitioner licensed or certified in this state who provides 67 telemedicine services. 68 Section 3. Section 456.4503, Florida Statutes, is created 69 to read: 70 456.4503 Telemedicine requirements.— 71 (1) A health care provider who provides telemedicine across 72 state lines to a patient physically located in this state must 73 be licensed or certified in this state. 74 (2) An out-of-state health care provider is exempt from 75 subsection (1) if: 76 (a) The out-of-state health care provider is consulting 77 with a telemedicine provider licensed to practice in this state; 78 (b) The telemedicine provider licensed in this state 79 retains ultimate authority and responsibility for the diagnosis, 80 treatment, and care of the patient located within this state; 81 and 82 (c) The out-of-state health care provider has privileges at 83 or is on the medical staff of an out-of-state hospital 84 affiliated with a Florida hospital licensed under chapter 395, 85 or has an affiliation with an out-of-state health insurer or 86 health plan that is also authorized to conduct business in this 87 state pursuant to chapter 627 or chapter 641. 88 (3) An out-of-state health care provider authorized under 89 subsection (2) to provide telemedicine services to patients in 90 this state is subject to appropriate disciplinary action by the 91 appropriate board in this state or other regulatory entity in 92 this state which has regulatory jurisdiction over the hospital, 93 insurer, or health plan affiliated with the health care 94 practitioner as described in paragraph (2)(c). 95 (4) A telemedicine provider and a hospital, insurer, or 96 health plan operating in this state which is affiliated with an 97 out-of-state health care practitioner as described in paragraph 98 (2)(c) shall make any pertinent records available upon request 99 of the appropriate board, the department, or other regulatory 100 authority as applicable. Failure to comply with such request may 101 result in the revocation of the provider’s license or 102 certification or imposition of a fine by the applicable board 103 or, in the case of an affiliated hospital, insurer, or health 104 plan, a fine, license restriction, or revocation of an 105 affiliated entity’s authorization to conduct business in this 106 state. 107 (5) Consultations that occur on an emergency basis and that 108 are conducted via telemedicine are exempt from subsection (1). 109 As used in this subsection, the term “emergency basis” refers to 110 the provision of emergency services and care for an emergency 111 medical condition, as those terms are defined in s. 395.002. 112 (6) A health care practitioner or patient presenter acting 113 under the direction and supervision of a telemedicine provider 114 through the use of telemedicine may not be interpreted as 115 practicing without a license. However, the health care 116 practitioner must be trained in, educated on, and knowledgeable 117 about the procedure and technology and may not perform duties 118 for which he or she does not have sufficient training, 119 education, and knowledge. Failure to have adequate training, 120 education, and knowledge is grounds for disciplinary action by 121 the appropriate board, or department if there is no board, or 122 the affiliated regulatory entity for affiliated providers. 123 (7) Upon license or certification renewal, the health care 124 practitioner practicing telemedicine shall: 125 (a) Designate himself or herself as a telemedicine provider 126 on the practitioner’s profile, if applicable; and 127 (b) Submit proof of successful completion of a course and 128 subsequent examination, approved by the applicable regulatory 129 board, or the department if there is no board, on the standards 130 of practice in telemedicine. The course must consist of 2 web 131 based contact hours. The first course and examination must be 132 offered by October 1, 2014, and shall be conducted at least 133 annually thereafter. The course and examination shall be 134 developed and offered by a statewide professional association 135 accredited to provide educational activities as designated by 136 the board. The board shall review and approve the content of the 137 initial course and examination if the board determines that the 138 course and examination adequately and reliably satisfy the 139 criteria set forth in this section. Annually thereafter, the 140 applicable regulatory board shall review the course and 141 examination and, if the board determines that the content 142 continues to adequately and reliably satisfy the criteria set 143 forth in this section, approve them. Successful completion of an 144 approved course and examination may be used to satisfy 2 hours 145 of continuing education requirements for the biennial period 146 during which the approved course and examination are taken. A 147 health care practitioner who does not complete an approved 148 course and examination under this section may not provide 149 telemedicine services. 150 (8) Venue for a civil or administrative action initiated by 151 the telemedicine recipient, the department, or the appropriate 152 board shall be based on the location of the patient or shall be 153 in Leon County. 154 (9) The boards may adopt rules to administer the 155 requirements of this act and must repeal rules that are 156 inconsistent with this act, including rules that prohibit the 157 use of telemedicine in this state. The appropriate board may 158 also develop standards and adopt rules relating to requirements 159 for patient presenters. Such rules may not require the use of 160 patient presenters in telemedicine services if special skills or 161 training is not needed for a patient to participate in the 162 encounter. 163 Section 4. Section 456.4504, Florida Statutes, is created 164 to read: 165 456.4504 Telemedicine standards.— 166 (1) The standard of care as provided in s. 766.102 is the 167 same regardless of whether the health care practitioner provides 168 health care services in person or by telemedicine. The 169 applicable board may adopt rules specifically related to the 170 standard of care for telemedicine. 171 (2) A telemedicine provider providing telemedicine services 172 under this act is responsible for the quality of the equipment 173 and technology employed and for its safe use. Telemedicine 174 equipment and advanced communications technology must, at a 175 minimum, be able to provide the same information to the 176 telemedicine provider as the information that would be obtained 177 in an in-person encounter with a health care provider and must 178 enable the telemedicine provider to meet or exceed the 179 prevailing standard of care for the practice of the profession. 180 (3) The telemedicine provider is not required to conduct a 181 patient history or physical examination of the patient before 182 engaging in a telemedicine encounter if the telemedicine 183 provider conducts a patient evaluation sufficient to meet the 184 prevailing standard of care for the services provided. 185 (4) Before each telemedicine encounter, the identification 186 and location of the telemedicine provider and all other 187 individuals present via advanced communications technology who 188 will view the patient or the patient’s information must be 189 identified to the patient. 190 (5) For the purposes of this act, the nonemergency 191 prescribing of a legend drug based solely on an electronic 192 questionnaire without a visual examination is considered a 193 failure to practice with the level of care, skill, and treatment 194 which is recognized by a reasonably prudent health care 195 practitioner and is not authorized under this act. 196 (6) A controlled substance may not be prescribed through 197 the use of telemedicine for chronic, nonmalignant pain. 198 (7) Medical records must be kept by each telemedicine 199 provider that participates in a patient telemedicine encounter 200 to the same extent as required for an in-person encounter under 201 state and federal law. Telemedicine providers are encouraged to 202 create electronic health records to document the encounter and 203 to transmit information in the most efficient manner possible. 204 (8) Any medical records generated, including records 205 maintained via video, audio, electronic, or other means, due to 206 a telemedicine encounter must conform to the confidentiality and 207 recordkeeping requirements of federal law and nationally 208 recognized health care accreditation organizations and the laws 209 and rules of this state, regardless of where the medical records 210 of a patient in this state are maintained. 211 (9) Telemedicine technology used by a telemedicine provider 212 must be encrypted and must use a recordkeeping program to verify 213 each interaction. 214 (10) In those situations in which a telemedicine provider 215 uses telemedicine technology provided by a third-party vendor, 216 the telemedicine provider must: 217 (a) Require a business associate agreement with the third 218 party vendor; and 219 (b) Ensure that the third-party vendor complies with the 220 administrative, physical, and technical safeguards and standards 221 set forth by the Health Information Technology for Economic and 222 Clinical Health (HITECH) Act and by federal regulations 223 implemented pursuant to HITECH. 224 Section 5. Section 456.4505, Florida Statutes, is created 225 to read: 226 456.4505 Telemedicine services to diagnose or treat the 227 human eye.— 228 (1) The use of automated equipment, including computer 229 controlled devices, in the provision of telemedicine services to 230 diagnose or treat the human eye and its appendages, is 231 permissible if the following requirements are met at the time 232 the automated equipment is used: 233 (a) The automated equipment is approved by the United 234 States Food and Drug Administration for the intended use; 235 (b) The automated equipment is designed and operated in a 236 manner that provides any accommodation required by the federal 237 ADA Amendments Act of 2008; 238 (c) The automated equipment and accompanying technology 239 used for the collection and transmission of information and 240 data, including photographs and scans, gathers and transmits 241 protected health information in compliance with the federal 242 Health Insurance Portability and Accountability Act; 243 (d) The procedure for which the automated equipment is used 244 has a recognized Current Procedural Terminology (CPT) code 245 approved by the Centers for Medicare and Medicaid Services; 246 (e) The physical location of the automated equipment 247 prominently displays the name and Florida license number of the 248 individual who will read and interpret the diagnostic 249 information and data, including photographs and scans; 250 (f) Diagnostic information and data, including photographs 251 and scans, gathered by the automated equipment is read and 252 interpreted by an optometrist licensed under chapter 463 or a 253 physician skilled in diseases of the human eye and licensed 254 under chapter 458 or chapter 459; and 255 (g) The owner or lessee of the automated equipment 256 maintains liability insurance in an amount adequate to cover 257 claims made by individuals diagnosed or treated based on 258 information and data, including photographs and scans, generated 259 by the automated equipment. 260 (2) A prescription for spectacles or contact lens may not 261 be made based on telemedicine services or based solely on the 262 refractive error of the human eye generated by a computer 263 controlled device such as an autorefractor. 264 Section 6. Section 456.4506, Florida Statutes, is created 265 to read: 266 456.4506 Telemedicine services under Medicaid.— 267 (1) The Agency for Health Care Administration may reimburse 268 for Medicaid services provided through telemedicine in the same 269 manner and equivalent to Medicaid services provided in-person 270 under parts III and IV of chapter 409, except as provided in 271 subsection (7). 272 (2) Telemedicine services reimbursed under Medicaid must 273 meet the standards and requirements of this act. 274 (3) Except as provided in subsection (7), the agency may 275 not require in-person contact between a telemedicine provider 276 and Medicaid recipient as a prerequisite for payment for 277 services appropriately provided through telemedicine in 278 accordance with generally accepted health care practices and 279 standards prevailing in the applicable health care community at 280 the time the services are provided. 281 (4) Before receipt of telemedicine services, a Medicaid 282 recipient or the legal representative of a Medicaid recipient 283 must provide informed consent for telemedicine services. A 284 Medicaid recipient shall also be provided the opportunity to 285 receive the same service through an in-person encounter. 286 (5) A Medicaid service that is provided through a fee-for 287 service or managed care program may not be denied as a 288 creditable Medicaid service solely because that service is 289 provided through telemedicine. 290 (6) Reimbursement of telemedicine services under Medicaid 291 shall be the amount negotiated between the parties involved to 292 the extent permitted under state and federal law. Regardless of 293 the reimbursement methodology or amount, telemedicine providers 294 located at the originating site and the distant site should both 295 receive reimbursement based on the services rendered, if any, 296 during the telemedicine encounter. 297 (7) If, after implementation, the agency determines that 298 the delivery of a particular service through telemedicine is not 299 cost-effective or does not adequately meet the clinical needs of 300 recipients and the determination has been documented, the agency 301 may discontinue Medicaid reimbursement for that telemedicine 302 service. 303 (8) The agency shall submit a report on the usage and 304 costs, including savings, if any, associated with the provision 305 of health care services through telemedicine under the Medicaid 306 program by January 1, 2017, to the President of the Senate, the 307 Speaker of the House of Representatives, and the minority 308 leaders of the Senate and the House of Representatives. 309 (9) This section is repealed June 30, 2017. 310 Section 7. This act shall take effect October 1, 2014. 311 312 ================= T I T L E A M E N D M E N T ================ 313 And the title is amended as follows: 314 Delete everything before the enacting clause 315 and insert: 316 A bill to be entitled 317 An act relating to telemedicine; creating s. 456.4501, 318 F.S.; providing a short title; creating s. 456.4502, 319 F.S.; defining terms applicable to the act; creating 320 s. 456.4503, F.S.; requiring specified practitioners 321 providing telemedicine services to patients in this 322 state to be licensed in this state; providing certain 323 exceptions for emergency services and consultations; 324 requiring pertinent records to be made available upon 325 request; requiring other health care providers to be 326 supervised by a telemedicine provider; providing 327 continuing education requirements for telemedicine 328 providers; establishing venue; authorizing the 329 licensing boards to adopt rules; creating s. 456.4504, 330 F.S.; providing standards and prohibitions for the 331 provision of telemedicine services; prohibiting 332 nonemergency prescribing of a legend drug without a 333 physical examination; prohibiting the prescription of 334 a controlled substance for chronic, nonmalignant pain 335 using telemedicine; establishing a method for 336 disciplinary action of out-of-state health providers; 337 requiring a telemedicine provider to keep medical 338 records of a patient; requiring the records to conform 339 to certain requirements; providing duties for a 340 telemedicine provider that uses telemedicine 341 technology provided by a third-party vendor; creating 342 s. 456.4505, F.S.; authorizing the use of telemedicine 343 services in the diagnosis and treatment of the human 344 eye; providing requirements for the use of automated 345 equipment; requiring the owner or lessee of the 346 automated equipment to maintain specified liability 347 insurance under certain circumstances; prohibiting 348 prescriptions for spectacles or contact lens based 349 solely on the use of an autorefractor; creating s. 350 456.4506, F.S.; providing requirements for 351 reimbursement of telemedicine services under the 352 Medicaid program; requiring a report to the 353 Legislature on the usage and costs of telemedicine 354 services under the Medicaid program by a certain date; 355 providing for future repeal; providing an effective 356 date.