Bill Text: FL S1198 | 2012 | Regular Session | Comm Sub
Bill Title: Prescribing of Controlled Substances [Track Bill]
Status: 2012-03-09 - Died in Criminal Justice, companion bill(s) passed, see CS/CS/HB 787 (Ch. [S1198 Detail]
Florida Senate - 2012 CS for SB 1198 By the Committee on Health Regulation; and Senator Bogdanoff 588-02713A-12 20121198c1 1 A bill to be entitled 2 An act relating to the prescribing of controlled 3 substances; amending s. 456.44, F.S.; revising the 4 definition of the term “addiction medicine specialist” 5 to include a board-certified psychiatrist, rather than 6 a physiatrist; redefining the term “board-certified 7 pain management physician” to include a physician who 8 possesses board certification or subcertification in 9 pain management by a specialty board recognized by the 10 American Board of Medical Specialties; redefining the 11 term “chronic nonmalignant pain”; providing 12 requirements that a physician who prescribes certain 13 specific controlled substances for the treatment of 14 chronic nonmalignant pain must fulfill; providing that 15 the management of pain in certain patients requires 16 consultation with or referral to a psychiatrist, 17 rather than a physiatrist; providing that a 18 prescription is deemed compliant with the standards of 19 practice and is valid for dispensing when a pharmacy 20 receives it; providing that the standards of practice 21 regarding the prescribing of controlled substances do 22 not apply to certain physicians; amending s. 458.3265, 23 F.S.; revising the definition of the term “chronic 24 nonmalignant pain”; requiring that a pain-management 25 clinic register with the Department of Health unless 26 the clinic is wholly owned by certain board-eligible 27 or board-certified physicians or medical specialists, 28 organized as a physician-owned group practice, or 29 wholly owned by physicians who are not board eligible 30 or board certified but who have completed specified 31 residency programs and have a specified number of 32 years of full-time practice in pain medicine; amending 33 s. 459.0137, F.S.; revising the definition of “chronic 34 nonmalginant pain”; requiring that a pain-management 35 clinic register with the Department of Health unless 36 the clinic is wholly owned by certain health care 37 practitioners; amending s. 465.0276, F.S.; redefining 38 the term “approved clinical trial” as it relates to 39 the Florida Pharmacy Act; amending s. 893.055, F.S.; 40 providing that a pharmacist or health care 41 practitioner is exempt from reporting a dispensed 42 controlled substance to the Department of Health when 43 administering the controlled substance to a patient 44 who is receiving hospice care or to a patient or 45 resident receiving care at certain medical facilities 46 licensed in the state; requiring that a pharmacy, 47 prescriber, or dispenser have access to information in 48 the prescription drug monitoring program’s database 49 which relates to a patient, or a potential patient, of 50 that pharmacy, prescriber, or dispenser for the 51 purpose of reviewing the patient’s controlled 52 substance prescription history; providing an effective 53 date. 54 55 Be It Enacted by the Legislature of the State of Florida: 56 57 Section 1. Section 456.44, Florida Statutes, is amended to 58 read: 59 456.44 Controlled substance prescribing.— 60 (1) DEFINITIONS.— 61 (a) “Addiction medicine specialist” means a board-certified 62 psychiatrist who holds
physiatrist witha subspecialty 63 certification in addiction medicine or who is eligible for such 64 subspecialty certification in addiction medicine, a an addiction65 medicine physician who is certified or eligible for 66 certification by the American Society of Addiction Medicine, or 67 an osteopathic physician who holds a certificate of added 68 qualification in Addiction Medicine through the American 69 Osteopathic Association. 70 (b) “Adverse incident” means any incident set forth in s. 71 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e). 72 (c) “Board–certified pain management physician” means a 73 physician who possesses board certification in pain medicine by 74 the American Board of Pain Medicine, board certification by the 75 American Board of Interventional Pain Physicians, or board 76 certification or subcertification in pain management by a 77 specialty board recognized by the American Association of 78 Physician Specialists or the American Board of Medical 79 Specialties or an osteopathic physician who holds a certificate 80 in Pain Management by the American Osteopathic Association. 81 (d) “Chronic nonmalignant pain” means pain unrelated to 82 cancer, orrheumatoid arthritis, or sickle cell anemia which 83 persists beyond the usual course of disease or beyond the injury 84 that is the cause of the pain or which persists more than 90 85 days after surgery. 86 (e) “Mental health addiction facility” means a facility 87 licensed under chapter 394 or chapter 397. 88 (2) REGISTRATION.—Effective January 1, 2012, a physician 89 licensed under chapter 458, chapter 459, chapter 461, or chapter 90 466 who prescribes any controlled substance listed in Schedule 91 II, Schedule III, or Schedule IV of as defined ins. 893.03, for 92 the treatment of chronic nonmalignant pain, must: 93 (a) Designate himself or herself as a controlled substance 94 prescribing practitioner on the physician’s practitioner 95 profile. 96 (b) Comply with the requirements of this section and 97 applicable board rules. 98 (3) STANDARDS OF PRACTICE.—The standards of practice in 99 this section do not supersede the level of care, skill, and 100 treatment recognized in general law related to health care 101 licensure. 102 (a) A complete medical history and a physical examination 103 must be conducted before beginning any treatment and must be 104 documented in the medical record. The exact components of the 105 physical examination shall be left to the judgment of the 106 clinician who is expected to perform a physical examination 107 proportionate to the diagnosis that justifies a treatment. The 108 medical record must, at a minimum, document the nature and 109 intensity of the pain, current and past treatments for pain, 110 underlying or coexisting diseases or conditions, the effect of 111 the pain on physical and psychological function, a review of 112 previous medical records, previous diagnostic studies, and 113 history of alcohol and substance abuse. The medical record must 114 shallalso document the presence of one or more recognized 115 medical indications for the use of a controlled substance. Each 116 registrant must develop a written plan for assessing each 117 patient’s risk of aberrant drug-related behavior, which may 118 include patient drug testing. Registrants must assess each 119 patient’s risk for aberrant drug-related behavior and monitor 120 that risk on an ongoing basis in accordance with the plan. 121 (b) Each registrant must develop a written individualized 122 treatment plan for each patient. The treatment plan must shall123 state objectives that will be used to determine treatment 124 success, such as pain relief and improved physical and 125 psychosocial function, and must shallindicate if any further 126 diagnostic evaluations or other treatments are planned. After 127 treatment begins, the physician shall adjust drug therapy to the 128 individual medical needs of each patient. Other treatment 129 modalities, including a rehabilitation program, shall be 130 considered depending on the etiology of the pain and the extent 131 to which the pain is associated with physical and psychosocial 132 impairment. The interdisciplinary nature of the treatment plan 133 shall be documented. 134 (c) The physician shall discuss the risks and benefits of 135 the use of controlled substances, including the risks of abuse 136 and addiction, as well as physical dependence and its 137 consequences, with the patient, persons designated by the 138 patient, or the patient’s surrogate or guardian if the patient 139 is incompetent. The physician shall use a written controlled 140 substance agreement between the physician and the patient 141 outlining the patient’s responsibilities, including, but not 142 limited to: 143 1. Number and frequency of prescriptions and refills for 144 controlled substances substance prescriptions and refills. 145 2. Patient compliance and reasons for which drug therapy 146 may be discontinued, such as a violation of the agreement. 147 3. An agreement that controlled substances for the 148 treatment of chronic nonmalignant pain shall be prescribed by a 149 single treating physician unless otherwise authorized by the 150 treating physician and documented in the medical record. 151 (d) The patient shall be seen by the physician at regular 152 intervals, not to exceed 3 months, to assess the efficacy of 153 treatment, ensure that controlled-substance controlled substance154 therapy remains indicated, evaluate the patient’s progress 155 toward treatment objectives, consider adverse drug effects, and 156 review the etiology of the pain. Continuation or modification of 157 therapy depends shall dependon the physician’s evaluation of 158 the patient’s progress. If treatment goals are not being 159 achieved, despite medication adjustments, the physician shall 160 reevaluate the appropriateness of continued treatment. The 161 physician shall monitor patient compliance in medication usage, 162 related treatment plans, controlled substance agreements, and 163 indications of substance abuse or diversion at a minimum of 3 164 month intervals. 165 (e) The physician shall refer the patient as necessary for 166 additional evaluation and treatment in order to achieve 167 treatment objectives. Special attention shall be given to those 168 patients who are at risk for misusing their medications and 169 those whose living arrangements pose a risk for medication 170 misuse or diversion. The management of pain in patients with a 171 history of substance abuse or with a comorbid psychiatric 172 disorder requires extra care, monitoring, and documentation and 173 requires consultation with or referral to an addictionologist or 174 psychiatrist physiatrist. 175 (f) A physician registered under this section must maintain 176 accurate, current, and complete records that are accessible and 177 readily available for review and comply with the requirements of 178 this section, the applicable practice act, and applicable board 179 rules. The medical records must include, but are not limited to: 180 1. The complete medical history and a physical examination, 181 including history of drug abuse or dependence. 182 2. Diagnostic, therapeutic, and laboratory results. 183 3. Evaluations and consultations. 184 4. Treatment objectives. 185 5. Discussion of risks and benefits. 186 6. Treatments. 187 7. Medications, including date, type, dosage, and quantity 188 prescribed. 189 8. Instructions and agreements. 190 9. Periodic reviews. 191 10. Results of any drug testing. 192 11. A photocopy of the patient’s government-issued photo 193 identification. 194 12. If a written prescription for a controlled substance is 195 given to the patient, a duplicate of the prescription. 196 13. The physician’s full name presented in a legible 197 manner. 198 (g) Patients with signs or symptoms of substance abuse 199 shall be immediately referred to a board-certified pain 200 management physician, an addiction medicine specialist, or a 201 mental health addiction facility as it pertains to drug abuse or 202 addiction unless the physician is board-certified or board 203 eligible in pain management. Throughout the period of time204 before receiving the consultant’s report, a prescribing 205 physician shall clearly and completely document medical 206 justification for continued treatment with controlled substances 207 and those steps taken to ensure medically appropriate use of 208 controlled substances by the patient. Upon receipt of the 209 consultant’s written report, the prescribing physician shall 210 incorporate the consultant’s recommendations for continuing, 211 modifying, or discontinuing the controlled-substance controlled212 substancetherapy. The resulting changes in treatment shall be 213 specifically documented in the patient’s medical record. 214 Evidence or behavioral indications of diversion shall be 215 followed by discontinuation of the controlled-substance 216 controlled substancetherapy, and the patient shall be 217 discharged, and all results of testing and actions taken by the 218 physician shall be documented in the patient’s medical record. 219 (h) When a pharmacy subject to this section receives a 220 prescription, the prescription is deemed compliant with the 221 standards of practice under this section and, therefore, valid 222 for dispensing. 223 224 This subsection does not apply to a board-eligible or board 225 certified anesthesiologist, physiatrist, psychiatrist, 226 rheumatologist, or neurologist, or to a board-certified 227 physician who has surgical privileges at a hospital or 228 ambulatory surgery center and primarily provides surgical 229 services. This subsection does not apply to a board-eligible or 230 board-certified medical specialist who has also completed a 231 fellowship in pain medicine approved by the Accreditation 232 Council for Graduate Medical Education or the American 233 Osteopathic Association, or who is board-eligible or board 234 certified in pain medicine by a board approved by the American 235 Board of Pain Medicine, the American Board of Medical 236 Specialties, or the American Osteopathic Association and 237 performs interventional pain procedures of the type routinely 238 billed using surgical codes. This subsection does not apply to a 239 physician certified by the American Board of Medical Specialties 240 in hospice and palliative medicine or to an osteopathic 241 physician who holds a certificate of added qualification in 242 hospice and palliative medicine through the American Osteopathic 243 Association. This subsection does not apply to hospitalists or 244 other physicians who prescribe medically necessary controlled 245 substances for a patient during an inpatient stay or while 246 providing emergency services and care in a hospital licensed 247 under chapter 395. This subsection does not apply to a physician 248 who is treating a patient in accordance with an approved 249 clinical trial. 250 Section 2. Paragraph (a) of subsection (1) of section 251 458.3265, Florida Statutes, is amended to read: 252 458.3265 Pain-management clinics.— 253 (1) REGISTRATION.— 254 (a)1. As used in this section, the term: 255 a. “Chronic nonmalignant pain” means pain unrelated to 256 cancer, orrheumatoid arthritis, or sickle cell anemia which 257 persists beyond the usual course of disease or beyond the injury 258 that is the cause of the pain or which persists more than 90 259 days after surgery. 260 b. “Pain-management clinic” or “clinic” means any publicly 261 or privately owned facility: 262 (I) That advertises in any medium for any type of pain 263 management services; or 264 (II) Where in any month a majority of patients are 265 prescribed opioids, benzodiazepines, barbiturates, or 266 carisoprodol for the treatment of chronic nonmalignant pain. 267 2. Each pain-management clinic must register with the 268 department unless: 269 a. The Thatclinic is licensed as a facility pursuant to 270 chapter 395; 271 b. The majority of the physicians who provide services in 272 the clinic primarilyprovide primarily surgical services; 273 c. The clinic is owned by a publicly held corporation whose 274 shares are traded on a national exchange or on the over-the 275 counter market and whose total assets at the end of the 276 corporation’s most recent fiscal quarter exceeded $50 million; 277 d. The clinic is affiliated with an accredited medical 278 school at which training is provided for medical students, 279 residents, or fellows; 280 e. The clinic does not prescribe controlled substances for 281 the treatment of pain; 282 f. The clinic is owned by a corporate entity exempt from 283 federal taxation under 26 U.S.C. s. 501(c)(3); 284 g. The clinic is wholly owned and operatedby one or more 285 board-eligible or board-certified anesthesiologists, 286 physiatrists, psychiatrists, rheumatologists, or neurologists; 287 or288 h. The clinic is wholly owned and operatedby one or more 289 board-eligible or board-certified medical specialists who have 290 also completed fellowships in pain medicine approved by the 291 Accreditation Council for Graduate Medical Education, or who are 292 also board-eligible or board-certified in pain medicine by a 293 board approved by the American Board of Pain Medicine or the 294 American Board of Medical Specialties and perform interventional 295 pain procedures of the type routinely billed using surgical 296 codes; .297 i. The clinic is organized as a physician-owned group 298 practice as defined in 42 C.F.R. 411,352; or 299 j. Before June 1, 2011, the clinic was wholly owned by 300 physicians who are not board eligible or board certified but who 301 successfully completed a residency program in anesthesiology, 302 physiatry, psychiatry, rheumatology, or neurology and who have 7 303 years of documented, full-time practice in pain medicine in this 304 state. For purposes of this paragraph, the term “full-time” is 305 defined as practicing an average of 20 hours per week each year 306 in pain medicine. 307 Section 3. Paragraph (a) of subsection (1) of section 308 459.0137, Florida Statutes, is amended to read: 309 459.0137 Pain-management clinics.— 310 (1) REGISTRATION.— 311 (a)1. As used in this section, the term: 312 a. “Chronic nonmalignant pain” means pain unrelated to 313 cancer, orrheumatoid arthritis, or sickle cell anemia which 314 persists beyond the usual course of disease or beyond the injury 315 that is the cause of the pain or which persists more than 90 316 days after surgery. 317 b. “Pain-management clinic” or “clinic” means any publicly 318 or privately owned facility: 319 (I) That advertises in any medium for any type of pain 320 management services; or 321 (II) Where in any month a majority of patients are 322 prescribed opioids, benzodiazepines, barbiturates, or 323 carisoprodol for the treatment of chronic nonmalignant pain. 324 2. Each pain-management clinic must register with the 325 department unless: 326 a. The Thatclinic is licensed as a facility pursuant to 327 chapter 395; 328 b. The majority of the physicians who provide services in 329 the clinic primarilyprovide primarily surgical services; 330 c. The clinic is owned by a publicly held corporation whose 331 shares are traded on a national exchange or on the over-the 332 counter market and whose total assets at the end of the 333 corporation’s most recent fiscal quarter exceeded $50 million; 334 d. The clinic is affiliated with an accredited medical 335 school at which training is provided for medical students, 336 residents, or fellows; 337 e. The clinic does not prescribe controlled substances for 338 the treatment of pain; 339 f. The clinic is owned by a corporate entity exempt from 340 federal taxation under 26 U.S.C. s. 501(c)(3); 341 g. The clinic is wholly owned and operatedby one or more 342 board-eligible or board-certified anesthesiologists, 343 physiatrists, psychiatrists, rheumatologists, or neurologists; 344 or 345 h. The clinic is wholly owned and operatedby one or more 346 board-eligible or board-certified medical specialists who have 347 also completed fellowships in pain medicine approved by the 348 Accreditation Council for Graduate Medical Education or the 349 American Osteopathic Association, or who are also board-eligible 350 or board-certified in pain medicine by a board approved by the 351 American Board of Medical Specialties, the American Association 352 of Physician Specialties, or the American Osteopathic 353 Association and perform interventional pain procedures of the 354 type routinely billed using surgical codes. 355 Section 4. Paragraph (b) of subsection (1) of section 356 465.0276, Florida Statutes, is amended to read: 357 465.0276 Dispensing practitioner.— 358 (1) 359 (b) A practitioner registered under this section may not 360 dispense a controlled substance listed in Schedule II or 361 Schedule III as provided in s. 893.03. This paragraph does not 362 apply to: 363 1. The dispensing of complimentary packages of medicinal 364 drugs which are labeled as a drug sample or complimentary drug 365 as defined in s. 499.028 to the practitioner’s own patients in 366 the regular course of her or his practice without the payment of 367 a fee or remuneration of any kind, whether direct or indirect, 368 as provided in subsection (5). 369 2. The dispensing of controlled substances in the health 370 care system of the Department of Corrections. 371 3. The dispensing of a controlled substance listed in 372 Schedule II or Schedule III in connection with the performance 373 of a surgical procedure. The amount dispensed pursuant to the 374 subparagraph may not exceed a 14-day supply. This exception does 375 not allow for the dispensing of a controlled substance listed in 376 Schedule II or Schedule III more than 14 days after the 377 performance of the surgical procedure. For purposes of this 378 subparagraph, the term “surgical procedure” means any procedure 379 in any setting which involves, or reasonably should involve: 380 a. Perioperative medication and sedation that allows the 381 patient to tolerate unpleasant procedures while maintaining 382 adequate cardiorespiratory function and the ability to respond 383 purposefully to verbal or tactile stimulation and makes intra- 384 and postoperative monitoring necessary; or 385 b. The use of general anesthesia or major conduction 386 anesthesia and preoperative sedation. 387 4. The dispensing of a controlled substance listed in 388 Schedule II or Schedule III pursuant to an approved clinical 389 trial. For purposes of this subparagraph, the term “approved 390 clinical trial” means a clinical research study or clinical 391 investigation that, in whole or in part, is state or federally 392 funded or is conducted under protocols approved an393 investigational new drug application that is reviewedby the 394 United States Food and Drug Administration. 395 5. The dispensing of methadone in a facility licensed under 396 s. 397.427 where medication-assisted treatment for opiate 397 addiction is provided. 398 6. The dispensing of a controlled substance listed in 399 Schedule II or Schedule III to a patient of a facility licensed 400 under part IV of chapter 400. 401 Section 5. Paragraph (b) of subsection (5) and paragraph 402 (b) of subsection (7) of section 893.055, Florida Statutes, are 403 amended to read: 404 893.055 Prescription drug monitoring program.— 405 (5) When the following acts of dispensing or administering 406 occur, the following are exempt from reporting under this 407 section for that specific act of dispensing or administration: 408 (b) A pharmacist or health care practitioner when 409 administering a controlled substance to a patient who is 410 receiving hospice care or to a patient or resident receiving 411 care as a patient at a hospital, nursing home, ambulatory 412 surgical center, hospice, or intermediate care facility for the 413 developmentally disabled which is licensed in this state. 414 (7) 415 (b) A pharmacy, prescriber, or dispenser shall have access 416 to information in the prescription drug monitoring program’s 417 database which relates to a patient, or a potential patient, of 418 that pharmacy, prescriber, or dispenser in a manner established 419 by the department as needed for the purpose of reviewing the 420 patient’s controlled substance prescription history. Other 421 access to the program’s database shall be limited to the 422 program’s manager and to the designated program and support 423 staff, who may act only at the direction of the program manager 424 or, in the absence of the program manager, as authorized. Access 425 by the program manager or such designated staff is for 426 prescription drug program management only or for management of 427 the program’s database and its system in support of the 428 requirements of this section and in furtherance of the 429 prescription drug monitoring program. Confidential and exempt 430 information in the database shall be released only as provided 431 in paragraph (c) and s. 893.0551. The program manager, 432 designated program and support staff who act at the direction of 433 or in the absence of the program manager, and any individual who 434 has similar access regarding the management of the database from 435 the prescription drug monitoring program shall submit 436 fingerprints to the department for background screening. The 437 department shall follow the procedure established by the 438 Department of Law Enforcement to request a statewide criminal 439 history record check and to request that the Department of Law 440 Enforcement forward the fingerprints to the Federal Bureau of 441 Investigation for a national criminal history record check. 442 Section 6. This act shall take effect July 1, 2012.