| 1 | A bill to be entitled |
| 2 | An act relating to pain-management clinics; amending ss. |
| 3 | 458.309 and 459.005, F.S.; prohibiting a person from |
| 4 | owning or operating a pain-management clinic unless he or |
| 5 | she is a physician with a clear and active license to |
| 6 | practice in this state; providing that a pain-management |
| 7 | clinic may not be owned by, employ, or contract with |
| 8 | certain physicians or certain persons; defining the term |
| 9 | "controlled substance"; prohibiting a person from |
| 10 | prescribing or dispensing any medication on the premises |
| 11 | of a pain-management clinic unless he or she is a |
| 12 | physician licensed under ch. 458 or ch. 459, F.S.; |
| 13 | providing an exception for a pharmacist licensed under ch. |
| 14 | 465, F.S.; providing an effective date. |
| 15 |
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| 16 | Be It Enacted by the Legislature of the State of Florida: |
| 17 |
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| 18 | Section 1. Subsections (4) and (5) of section 458.309, |
| 19 | Florida Statutes, are amended, and subsection (7) is added to |
| 20 | that section, to read: |
| 21 | 458.309 Rulemaking authority.- |
| 22 | (4)(a) All privately owned pain-management clinics, |
| 23 | facilities, or offices, hereinafter referred to as "clinics," |
| 24 | which advertise in any medium for any type of pain-management |
| 25 | services, or employ a physician who is primarily engaged in the |
| 26 | treatment of pain by prescribing or dispensing controlled |
| 27 | substances substance medications, must register with the |
| 28 | department by January 4, 2010, unless that clinic is licensed as |
| 29 | a facility pursuant to chapter 395. A person may not own or |
| 30 | operate a pain-management clinic in this state unless he or she |
| 31 | is a physician licensed under this chapter or chapter 459 and |
| 32 | the status of his or her license is clear and active according |
| 33 | to the Division of Medical Quality Assurance of the Department |
| 34 | of Health. A physician may not practice medicine in a pain- |
| 35 | management clinic that is required to but has not registered |
| 36 | with the department. Each clinic location shall be registered |
| 37 | separately regardless of whether the clinic is operated under |
| 38 | the same business name or management as another clinic. If the |
| 39 | clinic is licensed as a health care clinic under chapter 400, |
| 40 | the medical director is responsible for registering the facility |
| 41 | with the department. If the clinic is not registered pursuant to |
| 42 | chapter 395 or chapter 400, the clinic shall, upon registration |
| 43 | with the department, designate a physician who is responsible |
| 44 | for complying with all requirements related to registration of |
| 45 | the clinic. The designated physician shall be licensed under |
| 46 | this chapter or chapter 459 and shall practice at the office |
| 47 | location for which the physician has assumed responsibility. The |
| 48 | department shall inspect the clinic annually to ensure that it |
| 49 | complies with rules of the Board of Medicine adopted pursuant to |
| 50 | this paragraph subsection and subsection (5) unless the office |
| 51 | is accredited by a nationally recognized accrediting agency |
| 52 | approved by the Board of Medicine. The actual costs for |
| 53 | registration and inspection or accreditation shall be paid by |
| 54 | the physician seeking to register the clinic. |
| 55 | (b) A pain-management clinic may not be owned, either in |
| 56 | whole or in part, by or have any contractual relationship, |
| 57 | whether through employment or by independent contract, with: |
| 58 | 1. A physician who, during the course of his or her |
| 59 | practice, has been denied the privilege of prescribing, |
| 60 | dispensing, administering, supplying, or selling any controlled |
| 61 | substance and whose medical license, during the course of his or |
| 62 | her practice, has been suspended or revoked. |
| 63 | 2. A person who has been convicted of or who has pled |
| 64 | guilty or nolo contendere, regardless of whether adjudication |
| 65 | was withheld, to an offense that constitutes a felony. |
| 66 | (5) The Board of Medicine shall adopt rules setting forth |
| 67 | standards of practice for physicians practicing in privately |
| 68 | owned pain-management clinics that primarily engage in the |
| 69 | treatment of pain by prescribing or dispensing controlled |
| 70 | substances substance medications. Such rules shall address, but |
| 71 | need not be limited to, the following subjects: |
| 72 | (a) Facility operations; |
| 73 | (b) Physical operations; |
| 74 | (c) Infection control requirements; |
| 75 | (d) Health and safety requirements; |
| 76 | (e) Quality assurance requirements; |
| 77 | (f) Patient records; |
| 78 | (g) Training requirements for all facility health care |
| 79 | practitioners who are not regulated by another board; |
| 80 | (h) Inspections; and |
| 81 | (i) Data collection and reporting requirements. |
| 82 |
|
| 83 | A person may not prescribe or dispense any medication, including |
| 84 | a controlled substance, on the premises of a pain-management |
| 85 | clinic unless he or she is a physician licensed under this |
| 86 | chapter or chapter 459; however, a pharmacist licensed under |
| 87 | chapter 465 may dispense any medication, including a controlled |
| 88 | substance, on the premises of a pain-management clinic. A |
| 89 | physician is primarily engaged in the treatment of pain by |
| 90 | prescribing or dispensing controlled substances substance |
| 91 | medications when the majority of the patients seen are |
| 92 | prescribed or dispensed controlled substances substance |
| 93 | medications for the treatment of chronic nonmalignant pain. |
| 94 | Chronic nonmalignant pain is pain unrelated to cancer which |
| 95 | persists beyond the usual course of the disease or the injury |
| 96 | that is the cause of the pain or more than 90 days after |
| 97 | surgery. |
| 98 | (7) As used in this section, the term "controlled |
| 99 | substance" means a controlled substance listed in Schedule II, |
| 100 | Schedule III, or Schedule IV in s. 893.03. |
| 101 | Section 2. Subsections (3) and (4) of section 459.005, |
| 102 | Florida Statutes, are amended, and subsection (6) is added to |
| 103 | that section, to read: |
| 104 | 459.005 Rulemaking authority.- |
| 105 | (3)(a) All privately owned pain-management clinics, |
| 106 | facilities, or offices, hereinafter referred to as "clinics," |
| 107 | which advertise in any medium for any type of pain-management |
| 108 | services, or employ a physician who is licensed under this |
| 109 | chapter and who is primarily engaged in the treatment of pain by |
| 110 | prescribing or dispensing controlled substances substance |
| 111 | medications, must register with the department by January 4, |
| 112 | 2010, unless that clinic is licensed as a facility under chapter |
| 113 | 395. A person may not own or operate a pain-management clinic in |
| 114 | this state unless he or she is a physician licensed under this |
| 115 | chapter or chapter 458 and the status of his or her license is |
| 116 | clear and active according to the Division of Medical Quality |
| 117 | Assurance of the Department of Health. A physician may not |
| 118 | practice osteopathic medicine in a pain-management clinic that |
| 119 | is required to but has not registered with the department. Each |
| 120 | clinic location shall be registered separately regardless of |
| 121 | whether the clinic is operated under the same business name or |
| 122 | management as another clinic. If the clinic is licensed as a |
| 123 | health care clinic under chapter 400, the medical director is |
| 124 | responsible for registering the facility with the department. If |
| 125 | the clinic is not registered under chapter 395 or chapter 400, |
| 126 | the clinic shall, upon registration with the department, |
| 127 | designate a physician who is responsible for complying with all |
| 128 | requirements related to registration of the clinic. The |
| 129 | designated physician shall be licensed under chapter 458 or this |
| 130 | chapter and shall practice at the office location for which the |
| 131 | physician has assumed responsibility. The department shall |
| 132 | inspect the clinic annually to ensure that it complies with |
| 133 | rules of the Board of Osteopathic Medicine adopted pursuant to |
| 134 | this paragraph subsection and subsection (4) unless the office |
| 135 | is accredited by a nationally recognized accrediting agency |
| 136 | approved by the Board of Osteopathic Medicine. The actual costs |
| 137 | for registration and inspection or accreditation shall be paid |
| 138 | by the physician seeking to register the clinic. |
| 139 | (b) A pain-management clinic may not be owned, either in |
| 140 | whole or in part, by or have any contractual relationship, |
| 141 | whether through employment or by independent contract, with: |
| 142 | 1. A physician who, during the course of his or her |
| 143 | practice, has been denied the privilege of prescribing, |
| 144 | dispensing, administering, supplying, or selling any controlled |
| 145 | substance and whose medical license, during the course of his or |
| 146 | her practice, has been suspended or revoked. |
| 147 | 2. A person who has been convicted of or who has pled |
| 148 | guilty or nolo contendere, regardless of whether adjudication |
| 149 | was withheld, to an offense that constitutes a felony. |
| 150 | (4) The Board of Osteopathic Medicine shall adopt rules |
| 151 | setting forth standards of practice for physicians who practice |
| 152 | in privately owned pain-management clinics that primarily engage |
| 153 | in the treatment of pain by prescribing or dispensing controlled |
| 154 | substances substance medications. Such rules shall address, but |
| 155 | need not be limited to, the following subjects: |
| 156 | (a) Facility operations; |
| 157 | (b) Physical operations; |
| 158 | (c) Infection control requirements; |
| 159 | (d) Health and safety requirements; |
| 160 | (e) Quality assurance requirements; |
| 161 | (f) Patient records; |
| 162 | (g) Training requirements for all facility health care |
| 163 | practitioners who are not regulated by another board; |
| 164 | (h) Inspections; and |
| 165 | (i) Data collection and reporting requirements. |
| 166 |
|
| 167 | A person may not prescribe or dispense any medication, including |
| 168 | a controlled substance, on the premises of a pain-management |
| 169 | clinic unless he or she is a physician licensed under this |
| 170 | chapter or chapter 458; however, a pharmacist licensed under |
| 171 | chapter 465 may dispense any medication, including a controlled |
| 172 | substance, on the premises of a pain-management clinic. A |
| 173 | physician is primarily engaged in the treatment of pain by |
| 174 | prescribing or dispensing controlled substances substance |
| 175 | medications when the majority of the patients seen are |
| 176 | prescribed or dispensed controlled substances substance |
| 177 | medications for the treatment of chronic nonmalignant pain. |
| 178 | Chronic nonmalignant pain is pain unrelated to cancer which |
| 179 | persists beyond the usual course of the disease or the injury |
| 180 | that is the cause of the pain or more than 90 days after |
| 181 | surgery. |
| 182 | (6) As used in this section, the term "controlled |
| 183 | substance" means a controlled substance listed in Schedule II, |
| 184 | Schedule III, or Schedule IV in s. 893.03. |
| 185 | Section 3. This act shall take effect July 1, 2010. |