Florida Senate - 2012 COMMITTEE AMENDMENT Bill No. SB 1198 Barcode 390072 LEGISLATIVE ACTION Senate . House Comm: RCS . 01/31/2012 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Regulation (Diaz de la Portilla) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete lines 163 - 263 4 and insert: 5 This subsection does not apply to a board-certified 6 anesthesiologist, physiatrist, psychiatrist, rheumatologist, or 7 neurologist, or to a board-certified physician who has surgical 8 privileges at a hospital or ambulatory surgery center and 9 primarily provides surgical services. This subsection does not 10 apply to a board-certified medical specialist who has also 11 completed a fellowship in pain medicine approved by the 12 Accreditation Council for Graduate Medical Education or the 13 American Osteopathic Association, or who is board certified in 14 pain medicine by a board approved by the American Board of 15 Medical Specialties or the American Osteopathic Association and 16 performs interventional pain procedures of the type routinely 17 billed using surgical codes. This subsection does not apply to a 18 physician who is treating a patient in accordance with an 19 approved clinical trial. 20 Section 2. Paragraph (a) of subsection (1) of section 21 458.3265, Florida Statutes, is amended to read: 22 458.3265 Pain-management clinics.— 23 (1) REGISTRATION.— 24 (a)1. As used in this section, the term: 25 a. “Chronic nonmalignant pain” means pain unrelated to 26 cancer or rheumatoid arthritis which persists beyond the usual 27 course of disease or beyond the injury that is the cause of the 28 pain or which persists more than 90 days after surgery. 29 b. “Pain-management clinic” or “clinic” means any publicly 30 or privately owned facility: 31 (I) That advertises in any medium for any type of pain 32 management services; or 33 (II) Where in any month a majority of patients are 34 prescribed opioids, benzodiazepines, barbiturates, or 35 carisoprodol for the treatment of chronic nonmalignant pain. 36 2. Each pain-management clinic must register with the 37 department unless: 38 a. TheThatclinic is licensed as a facility pursuant to 39 chapter 395; 40 b. The majority of the physicians who provide services in 41 the clinicprimarilyprovide primarily surgical services; 42 c. The clinic is owned by a publicly held corporation whose 43 shares are traded on a national exchange or on the over-the 44 counter market and whose total assets at the end of the 45 corporation’s most recent fiscal quarter exceeded $50 million; 46 d. The clinic is affiliated with an accredited medical 47 school at which training is provided for medical students, 48 residents, or fellows; 49 e. The clinic does not prescribe controlled substances for 50 the treatment of pain; 51 f. The clinic is owned by a corporate entity exempt from 52 federal taxation under 26 U.S.C. s. 501(c)(3); 53 g. The clinic is wholly owned and operated by one or more 54 board-certified anesthesiologists, physiatrists, psychiatrists, 55 rheumatologists, or neurologists; or 56 h. The clinic is wholly owned and operated by one or more 57 board-certified medical specialists who have also completed 58 fellowships in pain medicine approved by the Accreditation 59 Council for Graduate Medical Education, or who are also board 60 certified in pain medicine by a board approved by the American 61 Board of Medical Specialties and perform interventional pain 62 procedures of the type routinely billed using surgical codes. 63 Section 3. Paragraph (a) of subsection (1) of section 64 459.0137, Florida Statutes, is amended to read: 65 459.0137 Pain-management clinics.— 66 (1) REGISTRATION.— 67 (a)1. As used in this section, the term: 68 a. “Chronic nonmalignant pain” means pain unrelated to 69 cancer or rheumatoid arthritis which persists beyond the usual 70 course of disease or beyond the injury that is the cause of the 71 pain or which persists more than 90 days after surgery. 72 b. “Pain-management clinic” or “clinic” means any publicly 73 or privately owned facility: 74 (I) That advertises in any medium for any type of pain 75 management services; or 76 (II) Where in any month a majority of patients are 77 prescribed opioids, benzodiazepines, barbiturates, or 78 carisoprodol for the treatment of chronic nonmalignant pain. 79 2. Each pain-management clinic must register with the 80 department unless: 81 a. TheThatclinic is licensed as a facility pursuant to 82 chapter 395; 83 b. The majority of the physicians who provide services in 84 the clinicprimarilyprovide primarily surgical services; 85 c. The clinic is owned by a publicly held corporation whose 86 shares are traded on a national exchange or on the over-the 87 counter market and whose total assets at the end of the 88 corporation’s most recent fiscal quarter exceeded $50 million; 89 d. The clinic is affiliated with an accredited medical 90 school at which training is provided for medical students, 91 residents, or fellows; 92 e. The clinic does not prescribe controlled substances for 93 the treatment of pain; 94 f. The clinic is owned by a corporate entity exempt from 95 federal taxation under 26 U.S.C. s. 501(c)(3); 96 g. The clinic is wholly owned and operated by one or more 97 board-certified anesthesiologists, physiatrists, psychiatrists, 98 rheumatologists, or neurologists; or 99 h. The clinic is wholly owned and operated by one or more 100 board-certified medical specialists who have also completed 101 fellowships in pain medicine approved by the Accreditation 102 Council for Graduate Medical Education or the American 103 Osteopathic Association, or who are also board-certified in pain 104 medicine by a board approved by the American Board of Medical 105 Specialties or the American Osteopathic Association and perform 106 interventional pain procedures of the type routinely billed 107 using surgical codes. 108 Section 4. Paragraph (b) of subsection (1) of section 109 465.0276, Florida Statutes, is amended to read: 110 465.0276 Dispensing practitioner.— 111 (1) 112 (b) A practitioner registered under this section may not 113 dispense a controlled substance listed in Schedule II or 114 Schedule III as provided in s. 893.03. This paragraph does not 115 apply to: 116 1. The dispensing of complimentary packages of medicinal 117 drugs which are labeled as a drug sample or complimentary drug 118 as defined in s. 499.028 to the practitioner’s own patients in 119 the regular course of her or his practice without the payment of 120 a fee or remuneration of any kind, whether direct or indirect, 121 as provided in subsection (5). 122 2. The dispensing of controlled substances in the health 123 care system of the Department of Corrections. 124 3. The dispensing of a controlled substance listed in 125 Schedule II or Schedule III in connection with the performance 126 of a surgical procedure. The amount dispensed pursuant to the 127 subparagraph may not exceed a 14-day supply. This exception does 128 not allow for the dispensing of a controlled substance listed in 129 Schedule II or Schedule III more than 14 days after the 130 performance of the surgical procedure. For purposes of this 131 subparagraph, the term “surgical procedure” means any procedure 132 in any setting which involves, or reasonably should involve: 133 a. Perioperative medication and sedation that allows the 134 patient to tolerate unpleasant procedures while maintaining 135 adequate cardiorespiratory function and the ability to respond 136 purposefully to verbal or tactile stimulation and makes intra- 137 and postoperative monitoring necessary; or 138 b. The use of general anesthesia or major conduction 139 anesthesia and preoperative sedation. 140 4. The dispensing of a controlled substance listed in 141 Schedule II or Schedule III pursuant to an approved clinical 142 trial. For purposes of this subparagraph, the term “approved 143 clinical trial” means a clinical research study or clinical 144 investigation that, in whole or in part, is state or federally 145 funded or is conducted under protocols approved byan146investigational new drug application that is reviewed bythe 147 United States Food and Drug Administration. 148 5. The dispensing of methadone in a facility licensed under 149 s. 397.427 where medication-assisted treatment for opiate 150 addiction is provided. 151 6. The dispensing of a controlled substance listed in 152 Schedule II or Schedule III to a patient of a facility licensed 153 under part IV of chapter 400. 154 155 ================= T I T L E A M E N D M E N T ================ 156 And the title is amended as follows: 157 Delete lines 11 - 19 158 and insert: 159 when a pharmacy receives it; providing that the 160 standards of practice regarding the prescribing of 161 controlled substances do not apply to certain 162 physicians; amending ss. 458.3265 and 459.0137, F.S.; 163 requiring that a pain-management clinic register with 164 the Department of Health unless the clinic is wholly 165 owned and operated by certain health care 166 professionals, including a board-certified 167 psychiatrist or rheumatologist; amending s. 465.0276, 168 F.S.; redefining the term “approved clinical trial” as 169 it relates to the Florida Pharmacy Act;