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28 | 28 | | STATE OF OKLAHOMA |
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29 | 29 | | |
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30 | 30 | | 2nd Session of the 58th Legislature (2022) |
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31 | 31 | | |
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32 | 32 | | HOUSE BILL 3004 By: West (Rick) |
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33 | 33 | | |
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34 | 34 | | |
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35 | 35 | | |
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36 | 36 | | |
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37 | 37 | | |
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38 | 38 | | AS INTRODUCED |
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39 | 39 | | |
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40 | 40 | | An Act relating to controlled dangerous substances; |
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41 | 41 | | defining terms; requiring pain management clinics to |
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42 | 42 | | register with State Board of Medical Licensure and |
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43 | 43 | | Supervision; providing exemptions; stipulating |
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44 | 44 | | registration procedures; requiring clinics to |
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45 | 45 | | designate physician; providing for the denial, |
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46 | 46 | | revocation, or suspension of registration under |
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47 | 47 | | certain circumstances; defining term; requiring |
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48 | 48 | | facility operations to cease when registration is |
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49 | 49 | | revoked or suspended; requiring removal of signage; |
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50 | 50 | | prohibiting person fr om applying to operate pain |
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51 | 51 | | management clinic for certain period of time after |
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52 | 52 | | revocation; limiting pe riod of suspension; requiring |
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53 | 53 | | new registration application if clinic changes |
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54 | 54 | | ownership; prohibiting physicians from practicing |
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55 | 55 | | medicine in unregistered pa in management clinics; |
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56 | 56 | | providing for disciplinary action for violations; |
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57 | 57 | | limiting who may prescribe co ntrolled dangerous |
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58 | 58 | | substances at registered pain management clinics; |
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59 | 59 | | prohibiting the dispensation of controlled dangerous |
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60 | 60 | | substances at pain management cl inics; specifying |
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61 | 61 | | physician responsibilities; providing facility and |
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62 | 62 | | physical operations requirements; stipulating certain |
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63 | 63 | | infection control requirements; providing safety |
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64 | 64 | | requirements for buildings, grounds , and equipment of |
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65 | 65 | | clinics; providing certain qual ity assurance |
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66 | 66 | | requirements; stipulating certain data collection and |
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67 | 67 | | reporting requirements; providing for the |
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68 | 68 | | accessibility of certain data and reports; providing |
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69 | 69 | | penalties; directing promulgation of rules; providing |
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70 | 70 | | for codification; and providing an effe ctive date. |
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101 | 101 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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102 | 102 | | SECTION 1. NEW LAW A new section of law to be codified |
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103 | 103 | | in the Oklahoma Statutes as Section 2-1111 of Title 63, unless there |
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104 | 104 | | is created a duplication in numbering, reads as follows: |
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105 | 105 | | As used in this act: |
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106 | 106 | | 1. "Board eligible" means successful completion of an |
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107 | 107 | | anesthesia, physical medicine and rehabilitation, rheumatology , or |
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108 | 108 | | neurology residency program approved by the Accreditation Council |
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109 | 109 | | for Graduate Medical Education or the American Osteopathic |
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110 | 110 | | Association for a period of six (6) years from successful com pletion |
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111 | 111 | | of such residency program; |
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112 | 112 | | 2. "Chronic nonmalignant pain " means pain unrelated to cancer |
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113 | 113 | | which persists beyond the usual course of disease or the injury that |
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114 | 114 | | is the cause of the pain or more than ninety (90) calendar days |
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115 | 115 | | after surgery; and |
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116 | 116 | | 3. "Pain management clinic" or "clinic" means any publicly or |
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117 | 117 | | privately owned facility: |
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118 | 118 | | a. that advertises in any medium for any type of pain |
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119 | 119 | | management services, and |
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120 | 120 | | b. where in any month a majority of patient s are |
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121 | 121 | | prescribed opioids, benzodiazepines, barbitur ates, or |
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122 | 122 | | carisoprodol for the treatment of chronic nonmalignant |
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123 | 123 | | pain. |
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149 | 149 | | |
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150 | 150 | | SECTION 2. NEW LAW A new section of law to be codified |
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151 | 151 | | in the Oklahoma Statutes as Section 2-1112 of Title 63, unless there |
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152 | 152 | | is created a duplication in numbering, reads as follows: |
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153 | 153 | | A. Each pain management clinic shall register with the State |
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154 | 154 | | Board of Medical Licensure and Supervision unless: |
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155 | 155 | | 1. The majority of the physicians who provide services in the |
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156 | 156 | | clinic primarily provide surgical services; |
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157 | 157 | | 2. The clinic is affiliated with an accredited medical school |
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158 | 158 | | at which training is provided for medical students, residents , or |
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159 | 159 | | fellows; |
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160 | 160 | | 3. The clinic does not prescribe c ontrolled dangerous |
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161 | 161 | | substances for the treatment of pain; |
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162 | 162 | | 4. The clinic is wholly owned and operated by one or more |
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163 | 163 | | board-eligible or board-certified anesthesiologists, physiatrists, |
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164 | 164 | | rheumatologists, or neurologists; or |
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165 | 165 | | 5. The clinic is wholly owned and o perated by a physician |
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166 | 166 | | multispecialty practice where one or more board -eligible or board- |
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167 | 167 | | certified medical specialists, who have also completed fellowships |
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168 | 168 | | in pain medicine approved by the Accreditation Council for Graduate |
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169 | 169 | | Medical Education or who are als o certified in pain medicine by the |
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170 | 170 | | American Board of Pain Medicine or a board approved by the America n |
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171 | 171 | | Board of Physician Specialties, the American Association of |
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172 | 172 | | Physician Specialists , or the American Osteopathic Association, |
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173 | 173 | | |
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198 | 198 | | |
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199 | 199 | | perform interventional pain p rocedures of the type routinely billed |
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200 | 200 | | using surgical codes. |
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201 | 201 | | B. Each clinic location shall be registe red separately |
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202 | 202 | | regardless of whether the clinic is operated under the same business |
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203 | 203 | | name or management as another clinic. |
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204 | 204 | | C. As a part of registration, a clinic shall designate a |
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205 | 205 | | physician who is responsible for complying with all requirements |
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206 | 206 | | related to registration and operation of the clinic in compliance |
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207 | 207 | | with this act. Within ten (10) calendar days after termination of a |
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208 | 208 | | designated physician, the clin ic shall notify the State Board of |
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209 | 209 | | Medical Licensure and Supervision of the identity of another |
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210 | 210 | | designated physician for that clinic. The designated physician |
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211 | 211 | | shall have a full, active , and unencumbered license pursuant to |
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212 | 212 | | Section 480 et seq. or Section 62 0 et seq. of Title 59 of the |
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213 | 213 | | Oklahoma Statutes and shall practice at the clinic location for |
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214 | 214 | | which the physician has assumed responsibility. Failing to have a |
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215 | 215 | | licensed designated physician practicing at the location of the |
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216 | 216 | | registered clinic may be the bas is for a summary suspension of the |
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217 | 217 | | clinic registration certificate as described in this section. |
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218 | 218 | | D. The State Board of Medical Licensure and Supervision shall |
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219 | 219 | | deny registration to any pain management clinic owned by or with any |
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220 | 220 | | contractual or employment r elationship with a physician: |
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221 | 221 | | 1. Whose Drug Enforcement Administration number has ever been |
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222 | 222 | | revoked; |
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223 | 223 | | |
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249 | 249 | | 2. Whose application for a license to prescribe, dispense , or |
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250 | 250 | | administer a controlled substance has been denied for disciplinary |
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251 | 251 | | action by the appropriate medical regulatory board of the physician; |
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252 | 252 | | or |
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253 | 253 | | 3. Who has been convicted of or pleaded guilty or nolo |
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254 | 254 | | contendere to, regardless of adjudication, an offense that |
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255 | 255 | | constitutes a felony for receipt of illicit or diverted drugs, |
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256 | 256 | | including a controlled substanc e listed in Schedule I, II, III, IV , |
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257 | 257 | | or V of the Uniform Controlled Dangerous Substances Act, in this |
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258 | 258 | | state, any other state or the United States. |
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259 | 259 | | E. If the State Board of Medical Licensure and Supervision |
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260 | 260 | | finds that a pain management clinic is owned, dire ctly or |
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261 | 261 | | indirectly, by a person meeting any criteria listed in subsection D |
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262 | 262 | | of this section, the State Board of Medical Licensure and |
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263 | 263 | | Supervision shall revoke the certificate of registration previously |
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264 | 264 | | issued by the State Board of Medical Licensure and Sup ervision. As |
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265 | 265 | | determined by rule, the State Board of Medical Licensure and |
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266 | 266 | | Supervision may grant an ex emption to denying a registration or |
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267 | 267 | | revoking a previously issued registration if more than five (5) |
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268 | 268 | | years have elapsed since adjudication. As used in th is section, the |
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269 | 269 | | term "convicted" includes an adjudication of guilt following a plea |
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270 | 270 | | of guilty or nolo contendere or the forfeiture of a bond when |
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271 | 271 | | charged with a crime. |
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272 | 272 | | |
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297 | 297 | | |
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298 | 298 | | F. If the registration of a pain management clinic is revoked |
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299 | 299 | | or suspended, the designa ted physician of the pain management |
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300 | 300 | | clinic, the owner or lessor of the pain management clinic propert y, |
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301 | 301 | | the manager, and the proprietor shall cease to operate the facility |
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302 | 302 | | as a pain management clinic as of the effective date of the |
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303 | 303 | | suspension or revocation . |
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304 | 304 | | G. If a pain management clinic registration is revoked or |
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305 | 305 | | suspended, the designated physician of th e pain management clinic, |
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306 | 306 | | the owner or lessor of the clinic property, the manager or the |
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307 | 307 | | proprietor shall be responsible for removing all signs and symbols |
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308 | 308 | | identifying the premises as a pain management clinic. |
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309 | 309 | | H. If the clinic's registration is revoked, any per son named in |
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310 | 310 | | the registration documents of the pain management clinic, including |
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311 | 311 | | persons owning or operating the pain management clinic, shall not, |
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312 | 312 | | as an individual or as a part of a group, apply to operate a pain |
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313 | 313 | | management clinic for one (1) year after t he date the registration |
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314 | 314 | | is revoked. |
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315 | 315 | | I. The period of suspension for the registration of a pain |
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316 | 316 | | management clinic shall be prescribed by the State Board of Medical |
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317 | 317 | | Licensure and Supervision but shall not exceed one (1) year. |
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318 | 318 | | J. A change of ownership of a registered pain management clinic |
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319 | 319 | | requires submission of a new registration application. |
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320 | 320 | | |
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345 | 345 | | |
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346 | 346 | | SECTION 3. NEW LAW A new section of law to be codified |
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347 | 347 | | in the Oklahoma Statutes as Section 2-1113 of Title 63, unless there |
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348 | 348 | | is created a duplication in numbering, reads as follows: |
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349 | 349 | | A. A physician shall not practice medicine in a pain management |
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350 | 350 | | clinic if the clinic is not registered with the State Board of |
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351 | 351 | | Medical Licensure and Supervision as required by this act. Any |
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352 | 352 | | physician who qualifies t o practice medicine in a pain management |
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353 | 353 | | clinic pursuant to rules adopted by the appropriate medical |
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354 | 354 | | regulatory board of the physician may continue to practice medicine |
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355 | 355 | | in a pain management clinic as long as the physician continues to |
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356 | 356 | | meet the qualificatio ns prescribed in the rules. A physician who |
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357 | 357 | | violates this subsection is subject to disciplinary action by the |
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358 | 358 | | appropriate medical regulatory board of the physician. |
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359 | 359 | | B. Only a physician licensed pursuant to Section 480 et seq. or |
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360 | 360 | | Section 620 et seq. of Ti tle 59 of the Oklahoma Statutes may |
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361 | 361 | | prescribe a controlled dangerous substance on the premises of a |
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362 | 362 | | registered pain management clinic. No person shall dispense any |
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363 | 363 | | controlled dangerous substance on the premises of a pain management |
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364 | 364 | | clinic. |
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365 | 365 | | C. A physician, a physician assistant, or an Advanced Practice |
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366 | 366 | | Registered Nurse shall perform a physical examination o f a patient |
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367 | 367 | | on the same day that the physician prescribes a controlled dangerous |
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368 | 368 | | substance to a patient at a pain management clinic. |
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369 | 369 | | |
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394 | 394 | | |
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395 | 395 | | D. A physician author ized to prescribe controlled dangerous |
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396 | 396 | | substances who practices at a pain management clinic is responsible |
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397 | 397 | | for maintaining the control and security of his or her prescription |
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398 | 398 | | blanks and any other method used for prescribing a controlled |
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399 | 399 | | dangerous substance pain medication. The physician shall notify, in |
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400 | 400 | | writing, the State Board of Medical Licensure and Supervision within |
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401 | 401 | | twenty-four (24) hours following any theft or loss of a prescription |
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402 | 402 | | blank or breach of any other method for prescribing pain medication. |
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403 | 403 | | E. The designated physician of a pain management clinic shall |
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404 | 404 | | notify the applicable board , in writing, of the date of termination |
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405 | 405 | | of employment within ten (10) calendar days after terminating his or |
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406 | 406 | | her employment with a pain management clinic that is re quired to be |
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407 | 407 | | registered pursuant to this act. Each physician practicing in a |
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408 | 408 | | pain management clinic shall advise the State Board of Medical |
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409 | 409 | | Licensure and Supervision, in writing, within ten (10) calendar days |
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410 | 410 | | after beginning or ending his or her practice at a pain management |
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411 | 411 | | clinic. |
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412 | 412 | | F. Each physician practicing in a pain management clinic is |
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413 | 413 | | responsible for ensurin g compliance with the facility and physical |
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414 | 414 | | operations requirements . A pain management clinic shall : |
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415 | 415 | | 1. Be located and operated at a publicly accessible fixed |
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416 | 416 | | location; |
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417 | 417 | | 2. Display a sign that can be viewed by the public that |
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418 | 418 | | contains the clinic name, hours of operation , and a street address ; |
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419 | 419 | | |
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444 | 444 | | |
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445 | 445 | | 3. Have a publicly listed telephone number and a dedicated |
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446 | 446 | | phone number to send and receive facs imiles; |
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447 | 447 | | 4. Have a reception and waiting area ; |
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448 | 448 | | 5. Provide a restroom; |
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449 | 449 | | 6. Have private patient examination rooms ; |
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450 | 450 | | 7. Have treatment rooms, if treatment is being provided to the |
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451 | 451 | | patients; and |
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452 | 452 | | 8. Display a printed sign located in a conspicuous place in the |
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453 | 453 | | waiting room, viewable by the public, with the name and contact |
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454 | 454 | | information of the clinic 's designated physician and the names of |
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455 | 455 | | all physicians practicing in the clinic . |
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456 | 456 | | The provisions of this section do not excuse a physician from |
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457 | 457 | | providing any treatment o r performing any medical duty without the |
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458 | 458 | | proper equipment and materials as required by the standard of care. |
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459 | 459 | | This section does not supersede the level of care, skill , or |
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460 | 460 | | treatment recognized i n general law related to health care |
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461 | 461 | | licensure. |
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462 | 462 | | G. Each physician practicing in a pain management clinic is |
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463 | 463 | | responsible for ensuring compliance with the following infection |
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464 | 464 | | control requirements: |
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465 | 465 | | 1. The clinic shall maintain equipment and supplies to supp ort |
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466 | 466 | | infection prevention and control activities; |
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467 | 467 | | 2. The clinic shall identify infection risks based on the |
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468 | 468 | | following: |
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494 | 494 | | |
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495 | 495 | | a. geographic location, community , and population served, |
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496 | 496 | | b. the care, treatment, and services it provides, and |
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497 | 497 | | c. an analysis of its infec tion surveillance and control |
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498 | 498 | | data; and |
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499 | 499 | | 3. The clinic shall maintain written infection-prevention |
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500 | 500 | | policies and procedures that address the following: |
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501 | 501 | | a. prioritized risks, |
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502 | 502 | | b. limiting unprotected exposure to pathogens, |
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503 | 503 | | c. limiting the transmission of infe ctions associated |
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504 | 504 | | with procedures performed in the clinic, a nd |
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505 | 505 | | d. limiting the transmission of infections associated |
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506 | 506 | | with the clinic's use of medical equipment, devices , |
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507 | 507 | | and supplies. |
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508 | 508 | | H. Each physician practicing in a pain management clinic is |
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509 | 509 | | responsible for ensuring that the clinic, including its grounds, |
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510 | 510 | | buildings, furniture, appliances, and equipment is structurally |
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511 | 511 | | sound, in good repair, clean , and free from health and safety |
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512 | 512 | | hazards. |
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513 | 513 | | I. The designated physician is responsible for ensuring |
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514 | 514 | | compliance with the following quality assurance requirements: |
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515 | 515 | | 1. Each pain management clinic shall have an ongoing quality |
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516 | 516 | | assurance program that objectively and systematically: |
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517 | 517 | | a. monitors and evaluates the quality and appropriateness |
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518 | 518 | | of patient care, |
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519 | 519 | | |
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545 | 545 | | b. evaluates methods to improve patient care, |
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546 | 546 | | c. identifies and corrects deficiencies within the |
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547 | 547 | | facility, |
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548 | 548 | | d. alerts the designated physician to identify and |
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549 | 549 | | resolve recurring problems, and |
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550 | 550 | | e. provides opportunities to improve the facility 's |
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551 | 551 | | performance and to enhanc e and improve the quality of |
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552 | 552 | | care provided to the public; and |
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553 | 553 | | 2. The designated physician shall establish a quality assurance |
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554 | 554 | | program that includes the following components: |
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555 | 555 | | a. the identification, investigation , and analysis of the |
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556 | 556 | | frequency and causes of adverse incidents to patients, |
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557 | 557 | | b. the identification of tren ds or patterns of incidents, |
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558 | 558 | | c. the development of measures to correct, reduce, |
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559 | 559 | | minimize, or eliminate the risk of a dverse incidents |
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560 | 560 | | to patients, and |
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561 | 561 | | d. the documentation of these functions and periodic |
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562 | 562 | | review no less than quarterly of such information by |
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563 | 563 | | the designated physician. |
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564 | 564 | | J. The designated physician is responsible for ensuring |
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565 | 565 | | compliance with the following dat a collection and reporting |
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566 | 566 | | requirements: |
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593 | 593 | | 1. The designated physician for each pain management clinic |
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594 | 594 | | shall report all adverse incidents to the State Board of Medical |
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595 | 595 | | Licensure and Supervision; and |
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596 | 596 | | 2. The designated physician shall also report to the Stat e |
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597 | 597 | | Board of Medical Licensure and Supervision, in writing, on a |
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598 | 598 | | quarterly basis the following data: |
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599 | 599 | | a. the number of new and repeat patients seen and treated |
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600 | 600 | | at the clinic who are prescribed controlled dangerous |
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601 | 601 | | substance medications for the treatment of ch ronic |
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602 | 602 | | nonmalignant pain, |
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603 | 603 | | b. the number of patients discharged due to drug abuse, |
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604 | 604 | | c. the number of patients discharged due to drug |
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605 | 605 | | diversion, and |
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606 | 606 | | d. the number of patients treated at the clinic whose |
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607 | 607 | | domicile is located somewhere other than in this |
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608 | 608 | | state. A patient's domicile is the patient 's fixed or |
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609 | 609 | | permanent home to which he or she intends to return |
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610 | 610 | | even though he or she may temporarily res ide |
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611 | 611 | | elsewhere. |
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612 | 612 | | K. The data and reports specified in subsection J of this |
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613 | 613 | | section shall be accessible to the Oklaho ma State Bureau of |
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614 | 614 | | Narcotics and Dangerous Drugs Control. |
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615 | 615 | | |
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640 | 640 | | |
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641 | 641 | | SECTION 4. NEW LAW A new section of law to be codified |
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642 | 642 | | in the Oklahoma Statutes as Section 2-1114 of Title 63, unless there |
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643 | 643 | | is created a duplication in numbering, reads as follows: |
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644 | 644 | | A. The State Board of Medical Licensure and Supervision may |
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645 | 645 | | impose an administrative fine on a clinic of up to Five Thousand |
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646 | 646 | | Dollars ($5,000.00) per violation for violating the requirements of |
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647 | 647 | | this act or the rules of the State Board of Medical Licensure and |
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648 | 648 | | Supervision. In determining whether a penalty is to be imposed, and |
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649 | 649 | | in fixing the amount of the fine, the State Board of Medical |
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650 | 650 | | Licensure and Supervision shall consider the following factors: |
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651 | 651 | | 1. The gravity of the violation, including the probability that |
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652 | 652 | | death or serious physical or emotional harm to a patient has |
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653 | 653 | | resulted, or could have resulted, from the pain management clinic 's |
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654 | 654 | | actions or the actions of the physician, the severity of the action |
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655 | 655 | | or potential harm and the extent to which the provisions of the |
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656 | 656 | | applicable laws or rules were violated; |
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657 | 657 | | 2. What actions, if any, the owner or designated physician took |
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658 | 658 | | to correct the violations; |
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659 | 659 | | 3. Whether there were any previous violations at the pain |
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660 | 660 | | management clinic; and |
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661 | 661 | | 4. The financial benefits that the pain management clinic |
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662 | 662 | | derived from committing or continuing to commit the violation. |
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663 | 663 | | B. Each day a violation continues after t he date fixed for |
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664 | 664 | | termination of the violation as ordered by the State Board of |
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665 | 665 | | |
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691 | 691 | | Medical Licensure and Supervision constitutes an additional, |
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692 | 692 | | separate, and distinct violation. |
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693 | 693 | | C. The State Board of Medical Licensure and Supervision may |
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694 | 694 | | impose a fine and, i n the case of an owner-operated pain management |
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695 | 695 | | clinic, revoke or deny a pain management clinic 's registration if |
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696 | 696 | | the clinic's designated physician knowingly and intentionally |
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697 | 697 | | misrepresents actions taken to correct a violation. |
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698 | 698 | | D. An owner or designated p hysician of a pain management clinic |
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699 | 699 | | who concurrently operates an unregistered pain management clinic is |
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700 | 700 | | subject to an administrative fine of Five Thousand Dollars |
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701 | 701 | | ($5,000.00) per day. |
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702 | 702 | | E. If the owner of a pain management clinic that requires |
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703 | 703 | | registration fails to apply to register the clinic upon a change of |
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704 | 704 | | ownership and operates the clinic under the new ownership, the owner |
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705 | 705 | | is subject to a fine of Five Thousand Dollars ($5,000.00). |
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706 | 706 | | SECTION 5. NEW LAW A new section of law to be co dified |
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707 | 707 | | in the Oklahoma Statutes as Section 2-1115 of Title 63, unless there |
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708 | 708 | | is created a duplication in numbering, reads as follows: |
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709 | 709 | | All affected agencies and boards shall promulgate such rules as |
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710 | 710 | | are necessary to implement the provisions of this act. |
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711 | 711 | | SECTION 6. This act shall become effective November 1, 2022. |
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712 | 712 | | |
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713 | 713 | | 58-2-8754 GRS 12/30/21 |
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