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.