| 1 | A bill to be entitled |
| 2 | An act relating to pain-management clinics; amending ss. |
| 3 | 458.309 and 459.005, F.S.; deleting provisions related to |
| 4 | pain-management clinics; creating ss. 458.3265 and |
| 5 | 459.0137, F.S.; requiring privately owned pain-management |
| 6 | clinics to be registered with the Department of Health by |
| 7 | a specified date; prohibiting a physician from practicing |
| 8 | in a pain-management clinic that is not registered with |
| 9 | the department; requiring that the Department of Health |
| 10 | refuse to issue a certificate of registration to or revoke |
| 11 | the registration of certain pain-management clinics that |
| 12 | are owned, directly or indirectly, by a person who has |
| 13 | been convicted of a felony; defining the term "convicted" |
| 14 | for purposes of this provision; designating persons who |
| 15 | are responsible for registering a clinic; providing |
| 16 | requirements for a physician who registers a clinic; |
| 17 | requiring the department to annually inspect a registered |
| 18 | clinic; providing for the automatic expiration of a |
| 19 | registration; requiring payment of costs for registration |
| 20 | and inspection or accreditation; requiring the Board of |
| 21 | Medicine and the Board of Osteopathic Medicine to adopt |
| 22 | rules setting forth standards of practice in privately |
| 23 | owned pain-management clinics; providing criteria for |
| 24 | physicians that practice pain-management; defining the |
| 25 | term "chronic nonmalignant pain"; providing that certain |
| 26 | pain-management clinics are exempt from registration |
| 27 | requirements under certain conditions; defining the term |
| 28 | "parties affiliated with a pain-management clinic"; |
| 29 | providing requirements for registering a pain-management |
| 30 | clinic; requiring the Department of Health to submit |
| 31 | fingerprints of an applicant for initial registration or |
| 32 | renewal of a registration to the Department of Law |
| 33 | Enforcement and the Federal Bureau of Investigation for a |
| 34 | criminal record check; providing that applicants are not |
| 35 | required to submit a set of fingerprints to the Department |
| 36 | of Health for a criminal record check under certain |
| 37 | conditions; providing an effective date. |
| 38 |
|
| 39 | Be It Enacted by the Legislature of the State of Florida: |
| 40 |
|
| 41 | Section 1. Section 458.309, Florida Statutes, is amended |
| 42 | to read: |
| 43 | 458.309 Rulemaking authority.- |
| 44 | (1) The board may has authority to adopt rules pursuant to |
| 45 | ss. 120.536(1) and 120.54 to implement the provisions of this |
| 46 | chapter conferring duties upon it. |
| 47 | (2)(a) Any rules which the board adopts relating to the |
| 48 | classroom phase of medical education shall not apply to any |
| 49 | person who is enrolled in the classroom phase of medical |
| 50 | education or has graduated prior to or at the time the rule |
| 51 | becomes effective, so long as such person does not interrupt his |
| 52 | or her medical education. |
| 53 | (b)1. Any rules which the board adopts relating to the |
| 54 | clinical clerkship phase of medical education shall not apply to |
| 55 | any person who is enrolled in the clinical clerkship phase of |
| 56 | medical education prior to or at the time the rule becomes |
| 57 | effective, so long as such person does not interrupt his or her |
| 58 | medical education. |
| 59 | 2. Rules adopted by the Florida Board of Medical Examiners |
| 60 | prior to October 1, 1986, and relating to clinical clerkships |
| 61 | for graduates of foreign medical schools do not apply to any |
| 62 | such graduate who: |
| 63 | a. Had completed a clinical clerkship prior to the |
| 64 | effective date of the rule; or |
| 65 | b. Had begun a clinical clerkship but had not completed |
| 66 | the clinical clerkship prior to the effective date of the rule, |
| 67 | so long as the clinical clerkship took no longer than 3 years to |
| 68 | complete. |
| 69 | (c) Any rules which the board adopts relating to residency |
| 70 | shall not apply to any person who has begun his or her residency |
| 71 | prior to or at the time the rule becomes effective, so long as |
| 72 | such person does not interrupt the residency. |
| 73 | (3) All physicians who perform level 2 procedures lasting |
| 74 | more than 5 minutes and all level 3 surgical procedures in an |
| 75 | office setting must register the office with the department |
| 76 | unless that office is licensed as a facility pursuant to chapter |
| 77 | 395. The department shall inspect the physician's office |
| 78 | annually unless the office is accredited by a nationally |
| 79 | recognized accrediting agency or an accrediting organization |
| 80 | subsequently approved by the Board of Medicine. The actual costs |
| 81 | for registration and inspection or accreditation shall be paid |
| 82 | by the person seeking to register and operate the office setting |
| 83 | in which office surgery is performed. |
| 84 | (4) All privately owned pain-management clinics, |
| 85 | facilities, or offices, hereinafter referred to as "clinics," |
| 86 | which advertise in any medium for any type of pain-management |
| 87 | services, or employ a physician who is primarily engaged in the |
| 88 | treatment of pain by prescribing or dispensing controlled |
| 89 | substance medications, must register with the department by |
| 90 | January 4, 2010, unless that clinic is licensed as a facility |
| 91 | pursuant to chapter 395. A physician may not practice medicine |
| 92 | in a pain-management clinic that is required to but has not |
| 93 | registered with the department. Each clinic location shall be |
| 94 | registered separately regardless of whether the clinic is |
| 95 | operated under the same business name or management as another |
| 96 | clinic. If the clinic is licensed as a health care clinic under |
| 97 | chapter 400, the medical director is responsible for registering |
| 98 | the facility with the department. If the clinic is not |
| 99 | registered pursuant to chapter 395 or chapter 400, the clinic |
| 100 | shall, upon registration with the department, designate a |
| 101 | physician who is responsible for complying with all requirements |
| 102 | related to registration of the clinic. The designated physician |
| 103 | shall be licensed under this chapter or chapter 459 and shall |
| 104 | practice at the office location for which the physician has |
| 105 | assumed responsibility. The department shall inspect the clinic |
| 106 | annually to ensure that it complies with rules of the Board of |
| 107 | Medicine adopted pursuant to this subsection and subsection (5) |
| 108 | unless the office is accredited by a nationally recognized |
| 109 | accrediting agency approved by the Board of Medicine. The actual |
| 110 | costs for registration and inspection or accreditation shall be |
| 111 | paid by the physician seeking to register the clinic. |
| 112 | (5) The Board of Medicine shall adopt rules setting forth |
| 113 | standards of practice for physicians practicing in privately |
| 114 | owned pain-management clinics that primarily engage in the |
| 115 | treatment of pain by prescribing or dispensing controlled |
| 116 | substance medications. Such rules shall address, but need not be |
| 117 | limited to, the following subjects: |
| 118 | (a) Facility operations; |
| 119 | (b) Physical operations; |
| 120 | (c) Infection control requirements; |
| 121 | (d) Health and safety requirements; |
| 122 | (e) Quality assurance requirements; |
| 123 | (f) Patient records; |
| 124 | (g) Training requirements for all facility health care |
| 125 | practitioners who are not regulated by another board; |
| 126 | (h) Inspections; and |
| 127 | (i) Data collection and reporting requirements. |
| 128 |
|
| 129 | A physician is primarily engaged in the treatment of pain by |
| 130 | prescribing or dispensing controlled substance medications when |
| 131 | the majority of the patients seen are prescribed or dispensed |
| 132 | controlled substance medications for the treatment of chronic |
| 133 | nonmalignant pain. Chronic nonmalignant pain is pain unrelated |
| 134 | to cancer which persists beyond the usual course of the disease |
| 135 | or the injury that is the cause of the pain or more than 90 days |
| 136 | after surgery. |
| 137 | (6) A privately owned clinic, facility, or office that |
| 138 | advertises in any medium for any type of pain-management |
| 139 | services or employs one or more physicians who are primarily |
| 140 | engaged in the treatment of pain by prescribing or dispensing |
| 141 | controlled substances is exempt from the registration provisions |
| 142 | in subsection (4) if the majority of the physicians who provide |
| 143 | services in the clinic, facility, or office primarily provide |
| 144 | surgical services. |
| 145 | Section 2. Section 459.005, Florida Statutes, is amended |
| 146 | to read: |
| 147 | 459.005 Rulemaking authority.- |
| 148 | (1) The board may has authority to adopt rules pursuant to |
| 149 | ss. 120.536(1) and 120.54 to implement the provisions of this |
| 150 | chapter conferring duties upon it. |
| 151 | (2) All physicians who perform level 2 procedures lasting |
| 152 | more than 5 minutes and all level 3 surgical procedures in an |
| 153 | office setting must register the office with the department |
| 154 | unless that office is licensed as a facility pursuant to chapter |
| 155 | 395. The department shall inspect the physician's office |
| 156 | annually unless the office is accredited by a nationally |
| 157 | recognized accrediting agency or an accrediting organization |
| 158 | subsequently approved by the Board of Osteopathic Medicine. The |
| 159 | actual costs for registration and inspection or accreditation |
| 160 | shall be paid by the person seeking to register and operate the |
| 161 | office setting in which office surgery is performed. |
| 162 | (3) All privately owned pain-management clinics, |
| 163 | facilities, or offices, hereinafter referred to as "clinics," |
| 164 | which advertise in any medium for any type of pain-management |
| 165 | services, or employ a physician who is licensed under this |
| 166 | chapter and who is primarily engaged in the treatment of pain by |
| 167 | prescribing or dispensing controlled substance medications, must |
| 168 | register with the department by January 4, 2010, unless that |
| 169 | clinic is licensed as a facility under chapter 395. A physician |
| 170 | may not practice osteopathic medicine in a pain-management |
| 171 | clinic that is required to but has not registered with the |
| 172 | department. Each clinic location shall be registered separately |
| 173 | regardless of whether the clinic is operated under the same |
| 174 | business name or management as another clinic. If the clinic is |
| 175 | licensed as a health care clinic under chapter 400, the medical |
| 176 | director is responsible for registering the facility with the |
| 177 | department. If the clinic is not registered under chapter 395 or |
| 178 | chapter 400, the clinic shall, upon registration with the |
| 179 | department, designate a physician who is responsible for |
| 180 | complying with all requirements related to registration of the |
| 181 | clinic. The designated physician shall be licensed under chapter |
| 182 | 458 or this chapter and shall practice at the office location |
| 183 | for which the physician has assumed responsibility. The |
| 184 | department shall inspect the clinic annually to ensure that it |
| 185 | complies with rules of the Board of Osteopathic Medicine adopted |
| 186 | pursuant to this subsection and subsection (4) unless the office |
| 187 | is accredited by a nationally recognized accrediting agency |
| 188 | approved by the Board of Osteopathic Medicine. The actual costs |
| 189 | for registration and inspection or accreditation shall be paid |
| 190 | by the physician seeking to register the clinic. |
| 191 | (4) The Board of Osteopathic Medicine shall adopt rules |
| 192 | setting forth standards of practice for physicians who practice |
| 193 | in privately owned pain-management clinics that primarily engage |
| 194 | in the treatment of pain by prescribing or dispensing controlled |
| 195 | substance medications. Such rules shall address, but need not be |
| 196 | limited to, the following subjects: |
| 197 | (a) Facility operations; |
| 198 | (b) Physical operations; |
| 199 | (c) Infection control requirements; |
| 200 | (d) Health and safety requirements; |
| 201 | (e) Quality assurance requirements; |
| 202 | (f) Patient records; |
| 203 | (g) Training requirements for all facility health care |
| 204 | practitioners who are not regulated by another board; |
| 205 | (h) Inspections; and |
| 206 | (i) Data collection and reporting requirements. |
| 207 |
|
| 208 | A physician is primarily engaged in the treatment of pain by |
| 209 | prescribing or dispensing controlled substance medications when |
| 210 | the majority of the patients seen are prescribed or dispensed |
| 211 | controlled substance medications for the treatment of chronic |
| 212 | nonmalignant pain. Chronic nonmalignant pain is pain unrelated |
| 213 | to cancer which persists beyond the usual course of the disease |
| 214 | or the injury that is the cause of the pain or more than 90 days |
| 215 | after surgery. |
| 216 | (5) A privately owned clinic, facility, or office that |
| 217 | advertises in any medium for any type of pain-management |
| 218 | services or employs one or more physicians who are primarily |
| 219 | engaged in the treatment of pain by prescribing or dispensing |
| 220 | controlled substances is exempt from the registration provisions |
| 221 | in subsection (3) if the majority of the physicians who provide |
| 222 | services in the clinic, facility, or office primarily provide |
| 223 | surgical services. |
| 224 | Section 3. Section 458.3265, Florida Statutes, is created |
| 225 | to read: |
| 226 | 458.3265 Pain-management clinics.- |
| 227 | (1) With the exception of facilities licensed under |
| 228 | chapter 395, all privately owned pain-management clinics, |
| 229 | facilities, or offices that are primarily engaged in the |
| 230 | treatment of pain by prescribing or dispensing controlled |
| 231 | substance medications, referred to as "clinics" in this section, |
| 232 | and advertise in any medium for any type of pain-management |
| 233 | services, or that employ a physician who is primarily engaged in |
| 234 | the treatment of pain by prescribing or dispensing controlled |
| 235 | substance medications, must register with the department by |
| 236 | January 4, 2010. A physician may not practice medicine in a |
| 237 | pain-management clinic that is not registered with the |
| 238 | department as required in this section. If the department finds |
| 239 | that a privately owned pain-management clinic is owned, directly |
| 240 | or indirectly, by a person who has been convicted of any felony |
| 241 | in this state or any other state or the United States, the |
| 242 | department shall refuse to issue a certificate of registration |
| 243 | to the clinic or shall revoke a certificate of registration |
| 244 | previously issued by the department. As used in this subsection, |
| 245 | the term "convicted" includes an adjudication of guilt on a plea |
| 246 | of guilty or nolo contendere, or the forfeiture of a bond when |
| 247 | charged with a crime. Each clinic location shall be registered |
| 248 | separately regardless of whether the clinic is operated under |
| 249 | the same business name or management as another clinic. If the |
| 250 | clinic is licensed as a health care clinic under chapter 400, |
| 251 | the medical director is responsible for registering the facility |
| 252 | with the department. If the clinic is not registered pursuant to |
| 253 | chapter 395 or chapter 400, the clinic shall, upon registration |
| 254 | with the department, designate a physician who is responsible |
| 255 | for complying with all requirements related to registration of |
| 256 | the clinic. The designated physician shall be licensed under |
| 257 | this chapter or chapter 459 and shall practice at the office |
| 258 | location for which the physician has assumed responsibility. The |
| 259 | department shall inspect the clinic annually to ensure that it |
| 260 | complies with rules of the board adopted pursuant to this |
| 261 | subsection and subsection (2) unless the clinic is accredited by |
| 262 | a nationally recognized accrediting agency approved by the |
| 263 | board. Registration under this section automatically expires |
| 264 | after 2 years without further action by the board or the |
| 265 | department unless an application for renewal is approved by the |
| 266 | board. The actual costs for registration and inspection or |
| 267 | accreditation shall be paid by the physician seeking to register |
| 268 | the clinic. |
| 269 | (2) The board shall adopt rules setting forth standards of |
| 270 | practice for physicians practicing in privately owned pain- |
| 271 | management clinics that primarily engage in the treatment of |
| 272 | pain by prescribing or dispensing controlled substance |
| 273 | medications. Such rules shall address, but need not be limited |
| 274 | to, the following: |
| 275 | (a) Facility operations; |
| 276 | (b) Physical operations; |
| 277 | (c) Infection control requirements; |
| 278 | (d) Health and safety requirements; |
| 279 | (e) Quality assurance requirements; |
| 280 | (f) Patient records; |
| 281 | (g) Training requirements for all facility health care |
| 282 | practitioners who are not regulated by another board; |
| 283 | (h) Inspections; and |
| 284 | (i) Data collection and reporting requirements. |
| 285 |
|
| 286 | A physician is primarily engaged in the treatment of pain by |
| 287 | prescribing or dispensing controlled substance medications when |
| 288 | the majority of the patients seen are prescribed or dispensed |
| 289 | controlled substance medications for the treatment of chronic |
| 290 | nonmalignant pain. Chronic nonmalignant pain is pain unrelated |
| 291 | to cancer which persists beyond the usual course of the disease |
| 292 | or the injury that is the cause of the pain or more than 90 days |
| 293 | after surgery. |
| 294 | (3) A privately owned clinic, facility, or office that is |
| 295 | primarily engaged in the treatment of pain by prescribing or |
| 296 | dispensing controlled substance medications and advertises in |
| 297 | any medium for any type of pain-management services, or that |
| 298 | employs one or more physicians who are primarily engaged in the |
| 299 | treatment of pain by prescribing or dispensing controlled |
| 300 | substance medications, is exempt from the registration |
| 301 | provisions in subsection (1) if the majority of the physicians |
| 302 | who provide services in the clinic, facility, or office |
| 303 | primarily provide surgical services. |
| 304 | (4) As used in this section, the term "parties affiliated |
| 305 | with a pain-management clinic" means: |
| 306 | (a) A director, officer, trustee, partner, or committee |
| 307 | member of a pain-management clinic or applicant or a subsidiary |
| 308 | or service corporation of the pain-management clinic or |
| 309 | applicant; or |
| 310 | (b) A person who, directly or indirectly, manages, |
| 311 | controls, or oversees the operation of a pain-management clinic |
| 312 | or applicant, regardless of whether the person is a partner, |
| 313 | shareholder, manager, member, officer, director, independent |
| 314 | contractor, or employee of the pain-management clinic or |
| 315 | applicant. |
| 316 | (5) An application for initial or renewal registration of |
| 317 | a pain-management clinic submitted to the department must |
| 318 | include: |
| 319 | (a) The name, full business address, and telephone number |
| 320 | of the applicant. |
| 321 | (b) All trade or business names used by the applicant. |
| 322 | (c) The address, telephone numbers, and names of contact |
| 323 | persons for each facility used by the applicant for the |
| 324 | prescribing or dispensing of controlled substance medications in |
| 325 | the treatment of pain. |
| 326 | (d) The type of ownership or operation, such as a |
| 327 | partnership, corporation, or sole proprietorship. |
| 328 | (e) The names of the owner and the operator of the pain- |
| 329 | management clinic, including: |
| 330 | 1. If an individual, the name of the individual. |
| 331 | 2. If a partnership, the name of each partner and the name |
| 332 | of the partnership. |
| 333 | 3. If a corporation: |
| 334 | a. The name, address, and title of each corporate officer |
| 335 | and director. |
| 336 | b. The name and address of the corporation and the |
| 337 | resident agent of the corporation, the resident agent's address, |
| 338 | and the corporation's state of incorporation. |
| 339 | c. The name and address of each shareholder of the |
| 340 | corporation that owns 5 percent or more of the outstanding stock |
| 341 | of the corporation. |
| 342 | 4. If a sole proprietorship, the full name of the sole |
| 343 | proprietor and the name of the business entity. |
| 344 | 5. If a limited liability company: |
| 345 | a. The name and address of each member. |
| 346 | b. The name and address of each manager. |
| 347 | c. The name and address of the limited liability company, |
| 348 | the resident agent of the limited liability company, and the |
| 349 | name of the state in which the limited liability company was |
| 350 | organized. |
| 351 | (f) The tax year of the applicant. |
| 352 | (g) A copy of the deed for the property on which the |
| 353 | applicant's pain-management clinic is located, if the clinic is |
| 354 | owned by the applicant, or a copy of the applicant's lease for |
| 355 | the property on which the applicant's pain-management clinic is |
| 356 | located, which must have an original term of not less than 1 |
| 357 | calendar year, if the pain-management clinic is not owned by the |
| 358 | applicant. |
| 359 | (h) A list of all licenses and permits issued to the |
| 360 | applicant by any other state which authorize the applicant to |
| 361 | purchase or possess prescription drugs. |
| 362 | (i) The name of the manager of the pain-management clinic |
| 363 | that is applying for the initial or renewal registration, the |
| 364 | next four highest ranking employees responsible for operations |
| 365 | of the pain-management clinic, the name of all parties |
| 366 | affiliated with the pain-management clinic, and the personal |
| 367 | information statement and fingerprints required under subsection |
| 368 | (6) for each of these persons. |
| 369 | (6)(a) Each person required by paragraph (5)(i) to provide |
| 370 | a personal information statement and fingerprints shall provide |
| 371 | the following information to the department on forms prescribed |
| 372 | by the department: |
| 373 | 1. The person's places of residence for the past 7 years. |
| 374 | 2. The person's date and place of birth. |
| 375 | 3. The person's occupations, positions of employment, and |
| 376 | offices held during the past 7 years. |
| 377 | 4. The principal business and address of any business, |
| 378 | corporation, or other organization in which the person: |
| 379 | a. Held an office during the past 7 years; or |
| 380 | b. Had an occupation or position of employment during the |
| 381 | past 7 years. |
| 382 | 5. Whether the person has been, during the past 7 years, |
| 383 | the subject of any proceeding for the revocation of any license |
| 384 | and, if so, the nature of the proceeding and the disposition of |
| 385 | the proceeding. |
| 386 | 6. Whether, during the past 7 years, the person has been |
| 387 | enjoined, temporarily or permanently, by a court of competent |
| 388 | jurisdiction from violating any federal or state law regulating |
| 389 | the possession, control, or distribution of prescription drugs, |
| 390 | together with details concerning any such event. |
| 391 | 7. A description of any involvement by the person during |
| 392 | the past 7 years, including any investments, other than the |
| 393 | ownership of stock in a publicly traded company or mutual fund, |
| 394 | with any business that manufactured, administered, prescribed, |
| 395 | distributed, or stored pharmaceutical products and any lawsuits |
| 396 | in which the businesses were named as a party. |
| 397 | 8. A description of any felony criminal offense of which |
| 398 | the person, as an adult, was found guilty, regardless of whether |
| 399 | adjudication of guilt was withheld or whether the person pled |
| 400 | guilty or nolo contendere. A criminal offense committed in |
| 401 | another jurisdiction which would have been a felony in this |
| 402 | state must be reported. If the person indicates that a criminal |
| 403 | conviction is under appeal and submits a copy of the notice of |
| 404 | appeal of that criminal offense, the applicant shall, within 15 |
| 405 | days after the disposition of the appeal, submit to the |
| 406 | department a copy of the final written order of disposition. |
| 407 | 9. A photograph of the person taken in the previous 30 |
| 408 | days. |
| 409 | 10. A set of fingerprints for the person on a form and |
| 410 | under procedures specified by the department and payment of an |
| 411 | amount equal to the costs incurred by the department for the |
| 412 | criminal record check of the person. |
| 413 | 11. The name, address, occupation, and date and place of |
| 414 | birth for each member of the person's immediate family who is 18 |
| 415 | years of age or older. As used in this subparagraph, the term |
| 416 | "member of the person's immediate family" includes the person's |
| 417 | spouse, children, parents, siblings, the spouses of the person's |
| 418 | children, and the spouses of the person's siblings. |
| 419 | 12. Any other relevant information that the department |
| 420 | requires. |
| 421 | (b) The information required under paragraph (a) shall be |
| 422 | provided under oath. |
| 423 | (c)1. The department shall submit the fingerprints |
| 424 | provided with an application for initial registration to the |
| 425 | Department of Law Enforcement for a statewide criminal record |
| 426 | check and for forwarding to the Federal Bureau of Investigation |
| 427 | for a national criminal record check. |
| 428 | 2. For the initial renewal of a registration on or after |
| 429 | January 1, 2010, the department shall submit the fingerprints |
| 430 | provided as a part of a renewal application to the Department of |
| 431 | Law Enforcement for a statewide criminal record check, and for |
| 432 | forwarding to the Federal Bureau of Investigation for a national |
| 433 | criminal record check. For any subsequent renewal of a |
| 434 | registration, the department shall submit the required |
| 435 | information for a statewide and national criminal record check. |
| 436 | 3. Any person who submits to the department a set of |
| 437 | fingerprints for a criminal record check is not required to |
| 438 | provide a subsequent set of fingerprints for a criminal record |
| 439 | check if the person has undergone a criminal record check as a |
| 440 | condition of the issuance of an initial registration or the |
| 441 | initial renewal of a registration on or after January 1, 2010. |
| 442 | Section 4. Section 459.0137, Florida Statutes, is created |
| 443 | to read: |
| 444 | 459.0137 Pain-management clinics.- |
| 445 | (1) With the exception of facilities licensed under |
| 446 | chapter 395, all privately owned pain-management clinics, |
| 447 | facilities, or offices that are primarily engaged in the |
| 448 | treatment of pain by prescribing or dispensing controlled |
| 449 | substance medications, referred to as "clinics" in this section, |
| 450 | and advertise in any medium for any type of pain-management |
| 451 | services, or that employ a physician who is licensed under this |
| 452 | chapter and who is primarily engaged in the treatment of pain by |
| 453 | prescribing or dispensing controlled substance medications, must |
| 454 | register with the department by January 4, 2010. A physician may |
| 455 | not practice osteopathic medicine in a pain-management clinic |
| 456 | that is not registered with the department as required in this |
| 457 | section. If the department finds that a privately owned pain- |
| 458 | management clinic is owned, directly or indirectly, by a person |
| 459 | who has been convicted of any felony in this state or any other |
| 460 | state or the United States, the department shall refuse to issue |
| 461 | a certificate of registration to the clinic or shall revoke a |
| 462 | certificate of registration previously issued by the department. |
| 463 | As used in this subsection, the term "convicted" includes an |
| 464 | adjudication of guilt on a plea of guilty or nolo contendere or |
| 465 | the forfeiture of a bond when charged with a crime. Each clinic |
| 466 | location shall be registered separately regardless of whether |
| 467 | the clinic is operated under the same business name or |
| 468 | management as another clinic. If the clinic is licensed as a |
| 469 | health care clinic under chapter 400, the medical director is |
| 470 | responsible for registering the facility with the department. If |
| 471 | the clinic is not registered under chapter 395 or chapter 400, |
| 472 | the clinic shall, upon registration with the department, |
| 473 | designate a physician who is responsible for complying with all |
| 474 | requirements related to registration of the clinic. The |
| 475 | designated physician shall be licensed under chapter 458 or this |
| 476 | chapter and shall practice at the office location for which the |
| 477 | physician has assumed responsibility. The department shall |
| 478 | inspect the clinic annually to ensure that it complies with |
| 479 | rules of the board of adopted pursuant to this subsection and |
| 480 | subsection (2) unless the clinic is accredited by a nationally |
| 481 | recognized accrediting agency approved by the board. |
| 482 | Registration under this section automatically expires after 2 |
| 483 | years without further action by the board or the department |
| 484 | unless an application for renewal is approved by the board. The |
| 485 | actual costs for registration and inspection or accreditation |
| 486 | shall be paid by the physician seeking to register the clinic. |
| 487 | (2) The board shall adopt rules setting forth standards of |
| 488 | practice for physicians who practice in privately owned pain- |
| 489 | management clinics that primarily engage in the treatment of |
| 490 | pain by prescribing or dispensing controlled substance |
| 491 | medications. Such rules shall address, but need not be limited |
| 492 | to, the following: |
| 493 | (a) Facility operations; |
| 494 | (b) Physical operations; |
| 495 | (c) Infection control requirements; |
| 496 | (d) Health and safety requirements; |
| 497 | (e) Quality assurance requirements; |
| 498 | (f) Patient records; |
| 499 | (g) Training requirements for all facility health care |
| 500 | practitioners who are not regulated by another board; |
| 501 | (h) Inspections; and |
| 502 | (i) Data collection and reporting requirements. |
| 503 |
|
| 504 | A physician is primarily engaged in the treatment of pain by |
| 505 | prescribing or dispensing controlled substance medications when |
| 506 | the majority of the patients seen are prescribed or dispensed |
| 507 | controlled substance medications for the treatment of chronic |
| 508 | nonmalignant pain. Chronic nonmalignant pain is pain unrelated |
| 509 | to cancer which persists beyond the usual course of the disease |
| 510 | or the injury that is the cause of the pain or more than 90 days |
| 511 | after surgery. |
| 512 | (3) A privately owned clinic, facility, or office that is |
| 513 | primarily engaged in the treatment of pain by prescribing or |
| 514 | dispensing controlled substance medications and advertises in |
| 515 | any medium for any type of pain-management services, or that |
| 516 | employs one or more physicians who are primarily engaged in the |
| 517 | treatment of pain by prescribing or dispensing controlled |
| 518 | substance medications, is exempt from the registration |
| 519 | provisions in subsection (1) if the majority of the physicians |
| 520 | who provide services in the clinic, facility, or office |
| 521 | primarily provide surgical services. |
| 522 | (4) As used in this section, the term "parties affiliated |
| 523 | with a pain-management clinic" means: |
| 524 | (a) A director, officer, trustee, partner, or committee |
| 525 | member of a pain-management clinic or applicant, or a subsidiary |
| 526 | or service corporation of the pain-management clinic or |
| 527 | applicant; |
| 528 | (b) A person who, directly or indirectly, manages, |
| 529 | controls, or oversees the operation of a pain-management clinic |
| 530 | or applicant, regardless of whether the person is a partner, |
| 531 | shareholder, manager, member, officer, director, independent |
| 532 | contractor, or employee of the pain-management clinic or |
| 533 | applicant. |
| 534 | (5) An application for initial or renewal registration as |
| 535 | a pain-management clinic submitted to the department must |
| 536 | include: |
| 537 | (a) The name, full business address, and telephone number |
| 538 | of the applicant. |
| 539 | (b) All trade or business names used by the applicant. |
| 540 | (c) The address, telephone numbers, and names of contact |
| 541 | persons for each facility used by the applicant for the |
| 542 | prescribing or dispensing of controlled substance medications in |
| 543 | the treatment of pain. |
| 544 | (d) The type of ownership or operation, such as a |
| 545 | partnership, corporation, or sole proprietorship. |
| 546 | (e) The names of the owner and the operator of the pain- |
| 547 | management clinic, including: |
| 548 | 1. If an individual, the name of the individual. |
| 549 | 2. If a partnership, the name of each partner and the name |
| 550 | of the partnership. |
| 551 | 3. If a corporation: |
| 552 | a. The name, address, and title of each corporate officer |
| 553 | and director. |
| 554 | b. The name and address of the corporation and the |
| 555 | resident agent of the corporation, the resident agent's address, |
| 556 | and the corporation's state of incorporation. |
| 557 | c. The name and address of each shareholder of the |
| 558 | corporation that owns 5 percent or more of the outstanding stock |
| 559 | of the corporation. |
| 560 | 4. If a sole proprietorship, the full name of the sole |
| 561 | proprietor and the name of the business entity. |
| 562 | 5. If a limited liability company: |
| 563 | a. The name and address of each member. |
| 564 | b. The name and address of each manager. |
| 565 | c. The name and address of the limited liability company, |
| 566 | the resident agent of the limited liability company, and the |
| 567 | name of the state in which the limited liability company was |
| 568 | organized. |
| 569 | (f) The tax year of the applicant. |
| 570 | (g) A copy of the deed for the property on which the |
| 571 | applicant's pain-management clinic is located, if the clinic is |
| 572 | owned by the applicant, or a copy of the applicant's lease for |
| 573 | the property on which the applicant's pain-management clinic is |
| 574 | located, which must have an original term of not less than 1 |
| 575 | calendar year, if the pain-management clinic is not owned by the |
| 576 | applicant. |
| 577 | (h) A list of all licenses and permits issued to the |
| 578 | applicant by any other state which authorize the applicant to |
| 579 | purchase or possess prescription drugs. |
| 580 | (i) The name of the manager of the pain-management clinic |
| 581 | that is applying for the initial or renewal registration, the |
| 582 | next four highest ranking employees responsible for operations |
| 583 | of the pain-management clinic, and the name of all parties |
| 584 | affiliated with the pain-management clinic, and the personal |
| 585 | information statement and fingerprints required under subsection |
| 586 | (6) for each of these persons. |
| 587 | (6)(a) Each person required by paragraph (5)(i) to provide |
| 588 | a personal information statement and fingerprints must provide |
| 589 | the following information to the department on forms prescribed |
| 590 | by the department: |
| 591 | 1. The person's places of residence for the past 7 years. |
| 592 | 2. The person's date and place of birth. |
| 593 | 3. The person's occupations, positions of employment, and |
| 594 | offices held during the past 7 years. |
| 595 | 4. The principal business and address of any business, |
| 596 | corporation, or other organization in which the person: |
| 597 | a. Held an office during the past 7 years; or |
| 598 | b. Had an occupation or position of employment during the |
| 599 | past 7 years. |
| 600 | 5. Whether the person has been, during the past 7 years, |
| 601 | the subject of any proceeding for the revocation of any license |
| 602 | and, if so, the nature of the proceeding and the disposition of |
| 603 | the proceeding. |
| 604 | 6. Whether, during the past 7 years, the person has been |
| 605 | temporarily or permanently enjoined by a court of competent |
| 606 | jurisdiction from violating any federal or state law regulating |
| 607 | the possession, control, or distribution of prescription drugs, |
| 608 | together with details concerning any such event. |
| 609 | 7. A description of any involvement by the person during |
| 610 | the past 7 years, including any investments, other than the |
| 611 | ownership of stock in a publicly traded company or mutual fund, |
| 612 | with any business that manufactured, administered, prescribed, |
| 613 | distributed, or stored pharmaceutical products and any lawsuits |
| 614 | in which the businesses were named as a party. |
| 615 | 8. A description of any felony criminal offense of which |
| 616 | the person, as an adult, was found guilty, regardless of whether |
| 617 | adjudication of guilt was withheld or whether the person pled |
| 618 | guilty or nolo contendere. A criminal offense committed in |
| 619 | another jurisdiction which would have been a felony in this |
| 620 | state must be reported. If the person indicates that a criminal |
| 621 | conviction is under appeal and submits a copy of the notice of |
| 622 | appeal of that criminal offense, the applicant must, within 15 |
| 623 | days after the disposition of the appeal, submit to the |
| 624 | department a copy of the final written order of disposition. |
| 625 | 9. A photograph of the person taken in the previous 30 |
| 626 | days. |
| 627 | 10. A set of fingerprints for the person on a form and |
| 628 | under procedures specified by the department, together with |
| 629 | payment of an amount equal to the costs incurred by the |
| 630 | department for the criminal record check of the person. |
| 631 | 11. The name, address, occupation, and date and place of |
| 632 | birth for each member of the person's immediate family who is 18 |
| 633 | years of age or older. As used in this subparagraph, the term |
| 634 | "member of the person's immediate family" includes the person's |
| 635 | spouse, children, parents, siblings, the spouses of the person's |
| 636 | children, and the spouses of the person's siblings. |
| 637 | 12. Any other relevant information that the department |
| 638 | requires. |
| 639 | (b) The information required under paragraph (a) shall be |
| 640 | provided under oath. |
| 641 | (c)1. The department shall submit the fingerprints |
| 642 | provided with an application for initial registration to the |
| 643 | Department of Law Enforcement for a statewide criminal record |
| 644 | check and for forwarding to the Federal Bureau of Investigation |
| 645 | for a national criminal record check. |
| 646 | 2. For the initial renewal of a registration on or after |
| 647 | January 1, 2010, the department shall submit the fingerprints |
| 648 | provided as a part of a renewal application to the Department of |
| 649 | Law Enforcement for a statewide criminal record check, and for |
| 650 | forwarding to the Federal Bureau of Investigation for a national |
| 651 | criminal record check. For any subsequent renewal of a permit, |
| 652 | the department shall submit the required information for a |
| 653 | statewide and national criminal record check. |
| 654 | 3. Any person who submits to the department a set of |
| 655 | fingerprints for a criminal record check is not required to |
| 656 | provide a subsequent set of fingerprints for a criminal record |
| 657 | check if the person has undergone a criminal record check as a |
| 658 | condition of the issuance of an initial registration or the |
| 659 | initial renewal of a registration on or after January 1, 2010. |
| 660 | Section 5. This act shall take effect July 1, 2010. |