August 18, 2019
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       Florida Senate - 2010                             CS for SB 2272
       
       
       
       By the Committee on Health Regulation; and Senators Fasano,
       Aronberg, Gaetz, and Gelber
       
       
       
       588-03759A-10                                         20102272c1
    1                        A bill to be entitled                      
    2         An act relating to pain management; amending s.
    3         456.037, F.S.; providing that pain-management clinics
    4         are business establishments subject to licensure by
    5         the Department of Health; requiring a health
    6         professional licensee who works at a pain-management
    7         clinic that prescribes controlled substances to be
    8         responsible for maintaining control and security over
    9         his or her blank prescription pads and any other
   10         method used to prescribe controlled substance pain
   11         medication; requiring the health professional licensee
   12         to notify the department within a specified time after
   13         the theft or loss of blank prescription pads;
   14         requiring a health professional licensee to give
   15         written notice to the applicable board within a
   16         specified period after the health professional
   17         licensee’s termination of employment at the pain
   18         management clinic; amending s. 456.057, F.S.;
   19         providing that the Department of Health is not
   20         required to attempt to obtain authorization from a
   21         patient for the release of the patient’s medical
   22         records under certain circumstances; amending s.
   23         456.069, F.S.; authorizing the Department of Health to
   24         inspect a pain-management clinic in a lawful manner at
   25         all reasonable hours for the purpose of determining if
   26         any provision of ch. 456, F.S., or any rule adopted by
   27         the department has been violated; authorizing the
   28         department to obtain patient records without
   29         authorization or subpoena if the department has
   30         probable cause to believe that a violation of s.
   31         456.072, F.S., has occurred or is occurring; amending
   32         s. 456.071, F.S.; providing venue for judicial
   33         challenges to any subpoena or order issued by the
   34         Department of Health during its investigations;
   35         amending s. 456.072, F.S.; providing additional acts
   36         that constitute grounds for disciplinary actions
   37         against health professional licensees; amending s.
   38         458.309, F.S.; requiring all privately owned pain
   39         management clinics, or offices that primarily engage
   40         in the treatment of pain by prescribing or dispensing
   41         controlled substance medications or that employ a
   42         physician who is primarily engaged in the treatment of
   43         pain by prescribing or dispensing controlled substance
   44         medications, to register with the Department of Health
   45         within a specified time; providing an exception;
   46         authorizing the department to deny an application for
   47         registering a pain-management clinic or to revoke or
   48         suspend the current registration certificate of a
   49         pain-management clinic for certain reasons;
   50         authorizing the department to impose fines for certain
   51         violations of law; requiring the department to
   52         consider certain factors when calculating the amount
   53         of the fine; providing that each day a violation
   54         continues constitutes an separate violation; requiring
   55         the pain-management clinic to document in writing all
   56         efforts undertaken by the pain-management clinic to
   57         correct a violation; providing that the owner or
   58         designated physician of a pain-management clinic is
   59         subject to an administrative fine; providing that the
   60         owner of a pain-management clinic who does not apply
   61         for a change-of-ownership license and who operates the
   62         clinic under a new ownership is subject to a fine;
   63         requiring the department to discuss each violation
   64         with the owner or designated physician of the pain
   65         management clinic before a formal written
   66         notification; requiring a pain-management clinic to
   67         cease operating if its registration certificate is
   68         revoked or suspended; requiring certain named persons
   69         to remove all signs and symbols identifying the
   70         premises as a pain-management clinic; prohibiting any
   71         person acting as an individual or as part of a group
   72         from applying for a certificate to operate a pain
   73         management clinic for a certain period after the date
   74         the person’s registration certificate is revoked;
   75         providing for disposition of drugs at a former pain
   76         management clinic; providing that certain clinics,
   77         facilities, and offices that advertise any type of
   78         pain-management services are exempt from the
   79         registration provisions under certain conditions;
   80         requiring the department and the Boards of Medicine
   81         and Osteopathic Medicine to adopt rules; creating ss.
   82         458.3265 and 459.0137, F.S.; providing for
   83         requirements for the registration of pain-management
   84         clinics; prohibiting a physician or an osteopathic
   85         physician from practicing medicine in a pain
   86         management clinic under certain conditions; requiring
   87         each location of a pain-management clinic to be
   88         registered separately regardless of whether the clinic
   89         is operated under the same business name or management
   90         as another clinic; prohibiting a pain-management
   91         clinic from being owned by or having any contractual
   92         relationship with certain specified persons; providing
   93         that if the department finds that a privately owned
   94         pain-management clinic is owned by a person possessing
   95         disqualifying criteria, the department shall refuse to
   96         register the pain-management clinic or revoke a
   97         previously issued certificate of registration;
   98         prohibiting a person from dispensing medication on the
   99         premises of a registered pain-management clinic unless
  100         he or she is a physician licensed under ch. 458 or ch.
  101         459, F.S.; requiring a physician to document in the
  102         patient’s record why the physician is prescribing or
  103         dispensing more than a specified amount of a
  104         controlled substances for the treatment of chronic
  105         nonmalignant pain; amending s. 458.327, F.S.;
  106         providing that the commission of certain specified
  107         acts while managing a pain-management clinic
  108         constitutes a felony of the third degree or a
  109         misdemeanor of the first degree; amending s. 459.005,
  110         F.S.; requiring all privately owned pain-management
  111         clinics, or offices that primarily engage in the
  112         treatment of pain by prescribing or dispensing
  113         controlled substance medications or that employ a
  114         physician who is primarily engaged in the treatment of
  115         pain by prescribing or dispensing controlled substance
  116         medications, to register with the Department of Health
  117         within a specified time; providing an exception;
  118         providing that certain clinics, facilities, and
  119         offices that advertise any type of pain-management
  120         services are exempt from the registration provisions
  121         under certain conditions; authorizing the department
  122         to deny an application for registering a pain
  123         management clinic or to revoke or suspend the current
  124         registration certificate of a pain-management clinic
  125         for certain reasons; authorizing the department to
  126         impose fines for certain violations of law; requiring
  127         the department to consider certain factors when
  128         calculating the amount of the fine; providing that
  129         each day a violation continues constitutes a separate
  130         violation; requiring the pain-management clinic to
  131         document in writing all efforts undertaken by the
  132         pain-management clinic to correct a violation;
  133         providing that the owner or designated physician of a
  134         pain-management clinic is subject to an administrative
  135         fine; providing that the owner of a pain-management
  136         clinic who does not apply for a change-of-ownership
  137         license and who operates the clinic under a new
  138         ownership is subject to a fine; requiring the
  139         department to discuss each violation with the owner or
  140         designated physician of the pain-management clinic
  141         before a formal written notification; requiring a
  142         pain-management clinic to cease operating if its
  143         registration certificate is revoked or suspended;
  144         requiring certain named persons to remove all signs
  145         and symbols identifying the premises as a pain
  146         management clinic; prohibiting any person acting as an
  147         individual or as part of a group from applying for a
  148         certificate to operate a pain-management clinic for a
  149         certain period after the date the person’s
  150         registration certificate is revoked; providing for
  151         disposition of drugs at a former pain-management
  152         clinic; requiring the department and the Boards of
  153         Medicine and Osteopathic Medicine to adopt rules;
  154         amending s. 459.013, F.S.; providing that the
  155         commission of certain specified acts while managing a
  156         pain-management clinic constitutes a felony of the
  157         third degree or a misdemeanor of the first degree;
  158         providing an effective date.
  159  
  160  Be It Enacted by the Legislature of the State of Florida:
  161  
  162         Section 1. Subsection (5) of section 456.037, Florida
  163  Statutes, is amended, and subsection (6) is added to that
  164  section, to read:
  165         456.037 Business establishments; requirements for active
  166  status licenses; delinquency; discipline; applicability.—
  167         (5) This section applies to any business establishment
  168  registered, permitted, or licensed by the department to do
  169  business. Business establishments include, but are not limited
  170  to, dental laboratories, electrology facilities, massage
  171  establishments, and pharmacies, and pain-management clinics
  172  required to be registered under s. 458.309 or s. 459.005.
  173         (6) A licensee authorized to prescribe controlled
  174  substances who practices at a pain-management clinic is
  175  responsible for maintaining the control and security of his or
  176  her prescription blanks and any other method used for
  177  prescribing controlled substance pain medication. The licensee
  178  shall comply with the requirements for counterfeit-resistant
  179  prescription blanks in s. 893.065 and the rules adopted pursuant
  180  to that section. The licensee shall notify in writing:
  181         (a)The department within 24 hours following any theft or
  182  loss of a prescription blank or breach of any other method for
  183  prescribing pain medication.
  184         (b)The applicable board of the date of termination of
  185  employment within 10 days after terminating his or her
  186  employment with a pain-management clinic required to be
  187  registered under s. 458.309.
  188         Section 2. Paragraph (a) of subsection (9) of section
  189  456.057, Florida Statutes, is amended to read:
  190         456.057 Ownership and control of patient records; report or
  191  copies of records to be furnished.—
  192         (9)(a)1. The department may obtain patient records pursuant
  193  to a subpoena without written authorization from the patient if
  194  the department and the probable cause panel of the appropriate
  195  board, if any, find reasonable cause to believe that a health
  196  care practitioner has excessively or inappropriately prescribed
  197  any controlled substance specified in chapter 893 in violation
  198  of this chapter or any professional practice act or that a
  199  health care practitioner has practiced his or her profession
  200  below that level of care, skill, and treatment required as
  201  defined by this chapter or any professional practice act and
  202  also find that appropriate, reasonable attempts were made to
  203  obtain a patient release. Notwithstanding the foregoing, the
  204  department need not attempt to obtain a patient release when
  205  investigating an offense involving the inappropriate
  206  prescribing, overprescribing, or diversion of controlled
  207  substances and the offense involves a pain-management clinic.
  208         2. The department may obtain patient records and insurance
  209  information pursuant to a subpoena without written authorization
  210  from the patient if the department and the probable cause panel
  211  of the appropriate board, if any, find reasonable cause to
  212  believe that a health care practitioner has provided inadequate
  213  medical care based on termination of insurance and also find
  214  that appropriate, reasonable attempts were made to obtain a
  215  patient release.
  216         3. The department may obtain patient records, billing
  217  records, insurance information, provider contracts, and all
  218  attachments thereto pursuant to a subpoena without written
  219  authorization from the patient if the department and probable
  220  cause panel of the appropriate board, if any, find reasonable
  221  cause to believe that a health care practitioner has submitted a
  222  claim, statement, or bill using a billing code that would result
  223  in payment greater in amount than would be paid using a billing
  224  code that accurately describes the services performed, requested
  225  payment for services that were not performed by that health care
  226  practitioner, used information derived from a written report of
  227  an automobile accident generated pursuant to chapter 316 to
  228  solicit or obtain patients personally or through an agent
  229  regardless of whether the information is derived directly from
  230  the report or a summary of that report or from another person,
  231  solicited patients fraudulently, received a kickback as defined
  232  in s. 456.054, violated the patient brokering provisions of s.
  233  817.505, or presented or caused to be presented a false or
  234  fraudulent insurance claim within the meaning of s.
  235  817.234(1)(a), and also find that, within the meaning of s.
  236  817.234(1)(a), patient authorization cannot be obtained because
  237  the patient cannot be located or is deceased, incapacitated, or
  238  suspected of being a participant in the fraud or scheme, and if
  239  the subpoena is issued for specific and relevant records.
  240         4. Notwithstanding subparagraphs 1.-3., when the department
  241  investigates a professional liability claim or undertakes action
  242  pursuant to s. 456.049 or s. 627.912, the department may obtain
  243  patient records pursuant to a subpoena without written
  244  authorization from the patient if the patient refuses to
  245  cooperate or if the department attempts to obtain a patient
  246  release and the failure to obtain the patient records would be
  247  detrimental to the investigation.
  248         Section 3. Section 456.069, Florida Statutes, is amended to
  249  read:
  250         456.069 Authority to inspect.—In addition to the authority
  251  specified in s. 465.017, duly authorized agents and employees of
  252  the department may shall have the power to inspect in a lawful
  253  manner at all reasonable hours:
  254         (1) Any pharmacy; or
  255         (2) Any establishment at which the services of a licensee
  256  authorized to prescribe controlled substances specified in
  257  chapter 893 are offered; or,
  258         (3) Any facility offering services that require the
  259  facility to be registered as a pain-management clinic pursuant
  260  to s. 458.309(4) or s. 459.005(3),
  261  
  262  for the purpose of determining if any of the provisions of this
  263  chapter or any practice act of a profession or any rule adopted
  264  thereunder is being violated; or for the purpose of securing
  265  such other evidence as may be needed for prosecution. Such
  266  evidence may include, but is not limited to, patient records.
  267  The department may obtain patient records without patient
  268  authorization or subpoena from any pain-management clinic
  269  required to be licensed if the department has probable cause to
  270  believe that a violation of any provision of s. 456.072 is
  271  occurring or has occurred and reasonably believes that obtaining
  272  such authorization is not feasible due to the volume of the
  273  dispensing and prescribing activity involving controlled
  274  substances and that obtaining patient authorization or the
  275  issuance of a subpoena would jeopardize the investigation.
  276         Section 4. Section 456.071, Florida Statutes, is amended to
  277  read:
  278         456.071 Power to administer oaths, take depositions, and
  279  issue subpoenas.—For the purpose of any investigation or
  280  proceeding conducted by the department, the department shall
  281  have the power to administer oaths, take depositions, make
  282  inspections when authorized by statute, issue subpoenas which
  283  shall be supported by affidavit, serve subpoenas and other
  284  process, and compel the attendance of witnesses and the
  285  production of books, papers, documents, and other evidence. The
  286  department shall exercise this power on its own initiative or
  287  whenever requested by a board or the probable cause panel of any
  288  board. Challenges to, and enforcement of, the subpoenas and
  289  orders shall be handled as provided in s. 120.569, except that
  290  venue is in the Circuit Court for the Second Judicial Circuit,
  291  in the county where the examination, investigation, or hearing
  292  is conducted, or in the county in which the person resides.
  293         Section 5. Paragraphs (mm), (nn), and (oo) are added to
  294  subsection (1) of section 456.072, Florida Statutes, to read:
  295         456.072 Grounds for discipline; penalties; enforcement.—
  296         (1) The following acts shall constitute grounds for which
  297  the disciplinary actions specified in subsection (2) may be
  298  taken:
  299         (mm) Applicable to a licensee who serves as the designated
  300  physician of a pain-management clinic as defined in s. 458.309
  301  or s. 459.005:
  302         1.Registering a pain-management clinic through
  303  misrepresentation or fraud;
  304         2.Procuring, or attempting to procure, the registration of
  305  a pain-management clinic for any other person by making or
  306  causing to be made, any false representation;
  307         3.Failing to comply with any requirement of chapter 499,
  308  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  309  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  310  the Drug Abuse Prevention and Control Act; or chapter 893, the
  311  Florida Comprehensive Drug Abuse Prevention and Control Act;
  312         4.Being convicted or found guilty of, regardless of
  313  adjudication to, a felony or any other crime involving moral
  314  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  315  the courts of this state, of any other state, or of the United
  316  States;
  317         5.Being convicted of, or disciplined by a regulatory
  318  agency of the Federal Government or a regulatory agency of
  319  another state for, any offense that would constitute a violation
  320  of this chapter;
  321         6.Being convicted of, or entering a plea of guilty or nolo
  322  contendere to, regardless of adjudication, a crime in any
  323  jurisdiction which relates to the practice of, or the ability to
  324  practice, a licensed health care profession;
  325         7.Being convicted of, or entering a plea of guilty or nolo
  326  contendere to, regardless of adjudication, a crime in any
  327  jurisdiction which relates to health care fraud;
  328         8.Dispensing any medicinal drug based upon a communication
  329  that purports to be a prescription as defined in s. 465.003(14)
  330  or s. 893.02 if the dispensing practitioner knows or has reason
  331  to believe that the purported prescription is not based upon a
  332  valid practitioner-patient relationship; or
  333         9.Failing to have a licensed medical director employed or
  334  under contract with the clinic as required by chapter 400 or
  335  failing to practice at the location of the registered clinic for
  336  which the professional is the designated physician. A violation
  337  of this paragraph may be the basis for a summary suspension as
  338  described in s. 456.073(8) or s. 120.60(6).
  339         (nn)Failing to timely notify the department of the theft
  340  of prescription blanks from a pain-management clinic or a breach
  341  of other methods for prescribing within 24 hours as required by
  342  s. 456.037(6).
  343         (oo)Failing to timely notify the applicable board
  344  governing his or her prescribing privileges of the date of his
  345  or her termination from a pain-management clinic as required by
  346  s. 456.037(6).
  347         Section 6. Section 458.309, Florida Statutes, is amended to
  348  read:
  349         458.309 Rulemaking authority.—
  350         (1) The board has authority to adopt rules pursuant to ss.
  351  120.536(1) and 120.54 to implement the provisions of this
  352  chapter conferring duties upon it.
  353         (2)(a) Any rules which the board adopts relating to the
  354  classroom phase of medical education shall not apply to any
  355  person who is enrolled in the classroom phase of medical
  356  education or has graduated prior to or at the time the rule
  357  becomes effective, so long as such person does not interrupt his
  358  or her medical education.
  359         (b)1. Any rules which the board adopts relating to the
  360  clinical clerkship phase of medical education shall not apply to
  361  any person who is enrolled in the clinical clerkship phase of
  362  medical education prior to or at the time the rule becomes
  363  effective, so long as such person does not interrupt his or her
  364  medical education.
  365         2. Rules adopted by the Florida Board of Medical Examiners
  366  prior to October 1, 1986, and relating to clinical clerkships
  367  for graduates of foreign medical schools do not apply to any
  368  such graduate who:
  369         a. Had completed a clinical clerkship prior to the
  370  effective date of the rule; or
  371         b. Had begun a clinical clerkship but had not completed the
  372  clinical clerkship prior to the effective date of the rule, so
  373  long as the clinical clerkship took no longer than 3 years to
  374  complete.
  375         (c) Any rules which the board adopts relating to residency
  376  shall not apply to any person who has begun his or her residency
  377  prior to or at the time the rule becomes effective, so long as
  378  such person does not interrupt the residency.
  379         (3) All physicians who perform level 2 procedures lasting
  380  more than 5 minutes and all level 3 surgical procedures in an
  381  office setting must register the office with the department
  382  unless that office is licensed as a facility pursuant to chapter
  383  395. The department shall inspect the physician’s office
  384  annually unless the office is accredited by a nationally
  385  recognized accrediting agency or an accrediting organization
  386  subsequently approved by the Board of Medicine. The actual costs
  387  for registration and inspection or accreditation shall be paid
  388  by the person seeking to register and operate the office setting
  389  in which office surgery is performed.
  390         (4) Effective January 4, 2010, all privately owned pain
  391  management clinics, facilities, or offices, hereinafter referred
  392  to as “clinics,” which advertise in any medium for any type of
  393  pain-management services, or employ a physician who is primarily
  394  engaged in the treatment of pain by prescribing or dispensing
  395  controlled substance medications, must register with the
  396  department by January 4, 2010, unless that clinic is licensed as
  397  a facility pursuant to chapter 395. A physician may not practice
  398  medicine in a pain-management clinic that is required to but has
  399  not registered with the department. Each clinic location shall
  400  be registered separately regardless of whether the clinic is
  401  operated under the same business name or management as another
  402  clinic. If the clinic is licensed as a health care clinic under
  403  chapter 400, the medical director is responsible for registering
  404  the facility with the department. If the clinic is not
  405  registered pursuant to chapter 395 or chapter 400, the clinic
  406  shall, upon registration with the department, designate a
  407  physician who is responsible for complying with all requirements
  408  related to registration of the clinic. The designated physician
  409  shall have a full, active, and unencumbered license be licensed
  410  under this chapter or chapter 459 and shall practice at the
  411  office location for which the physician has assumed
  412  responsibility. The department shall inspect the clinic
  413  annually, including a review of the patient records, to ensure
  414  that it complies with rules of the Board of Medicine adopted
  415  pursuant to this subsection and subsection (6) (5) unless the
  416  office is accredited by a nationally recognized accrediting
  417  agency approved by the Board of Medicine. The actual costs for
  418  registration and inspection or accreditation shall be paid by
  419  the physician seeking to register the clinic.
  420         (5)(a)The department may deny an application for
  421  registering a pain-management clinic or revoke or suspend a
  422  current registration. The department may impose an
  423  administrative fine on the clinic of up to $5,000 per violation
  424  for violating the requirements of this section, chapter 499, the
  425  Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  426  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  427  the Drug Abuse Prevention and Control Act; or chapter 893, the
  428  Florida Comprehensive Drug Abuse Prevention and Control Act; or
  429  the rules of the department. In determining whether a penalty is
  430  to be imposed, and in fixing the amount of the fine, the
  431  department shall consider the following factors:
  432         1. The gravity of the violation, including the probability
  433  that death or serious physical or emotional harm to a patient
  434  has resulted, or could have resulted, from a licensee’s actions,
  435  the severity of the action or potential harm, and the extent to
  436  which the provisions of the applicable laws or rules were
  437  violated.
  438         2. What actions, if any, the owner or designated physician
  439  took to correct the violations.
  440         3. Whether there were any previous violations at the pain
  441  management clinic.
  442         4. The financial benefits that the pain-management clinic
  443  derived from committing or continuing to commit the violation.
  444         (b) Each day a violation continues after the date fixed for
  445  termination as ordered by the department, constitutes an
  446  additional, separate, and distinct violation.
  447         (c) Any action taken to correct a violation shall be
  448  documented in writing by the owner or designated physician of
  449  the pain-management clinic and verified by followup visits by
  450  departmental personnel. The department may impose a fine and, in
  451  the case of an owner-operated pain-management clinic may revoke
  452  or deny a clinic’s registration, if the clinic’s designated
  453  physician knowingly and intentionally misrepresents actions
  454  taken to correct a violation.
  455         (d) An owner or designated physician of a pain-management
  456  clinic who concurrently operates an unregistered pain-management
  457  clinic is subject to an administrative fine of $5,000 per day.
  458         (e) If the owner of a pain-management clinic fails to apply
  459  for a change-of-ownership registration and operates the clinic
  460  under the new ownership, the owner is subject to a fine of
  461  $5,000.
  462         (f) During an onsite inspection, the department shall make
  463  a reasonable attempt to discuss each violation with the owner or
  464  designated physician of the pain-management clinic before
  465  issuing a formal written notification.
  466         (g)1.If the registration of a pain-management clinic is
  467  revoked or suspended, the designated physician of the pain
  468  management clinic, the owner or lessor of the pain-management
  469  clinic property, and the owner, manager, or proprietor shall
  470  cease to operate the facility as a pain-management clinic as of
  471  the effective date of the suspension or revocation.
  472         2.If a pain-management clinic registration is revoked or
  473  suspended, the designated physician of the pain-management
  474  clinic, the owner or lessor of the clinic property, or the
  475  owner, manager, or proprietor is responsible for removing all
  476  signs and symbols identifying the premises as a pain-management
  477  clinic.
  478         3.If the clinic’s registration is revoked, any person
  479  named in the registration documents of the pain-management
  480  clinic, including persons owning or operating the pain
  481  management clinic, may not, as an individual or as a part of a
  482  group, apply to operate a pain-management clinic for 5 years
  483  after the date the registration is revoked.
  484         4.Upon the effective date of the suspension or revocation,
  485  the pain-management clinic shall advise the department of the
  486  disposition of the medicinal drugs located on the premises. The
  487  disposition is subject to the supervision and approval of the
  488  department. Medicinal drugs that are purchased or held by a
  489  pain–management clinic that is not registered may be deemed
  490  adulterated pursuant to s. 499.006.
  491         5.The period of the suspension shall be prescribed by the
  492  department, but may not exceed 1 year.
  493         (6)(5) The Board of Medicine shall adopt rules setting
  494  forth standards of practice for physicians practicing in
  495  privately owned pain-management clinics that primarily engage in
  496  the treatment of pain by prescribing or dispensing controlled
  497  substance medications. Such rules shall address, but need not be
  498  limited to, the following subjects:
  499         (a) Facility operations;
  500         (b) Physical operations;
  501         (c) Infection control requirements;
  502         (d) Health and safety requirements;
  503         (e) Quality assurance requirements;
  504         (f) Patient records;
  505         (g) Training requirements for all facility health care
  506  practitioners who are not regulated by another board;
  507         (h) Inspections; and
  508         (i) Data collection and reporting requirements.
  509  
  510  A physician is primarily engaged in the treatment of pain by
  511  prescribing or dispensing controlled substance medications when
  512  the majority of the patients seen are prescribed or dispensed
  513  controlled substance medications for the treatment of chronic
  514  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  515  to cancer which persists beyond the usual course of the disease
  516  or the injury that is the cause of the pain or more than 90 days
  517  after surgery.
  518         (7)(6) A privately owned clinic, facility, or office that
  519  advertises in any medium for any type of pain-management
  520  services or employs one or more physicians who are primarily
  521  engaged in the treatment of pain by prescribing or dispensing
  522  controlled substances is exempt from the registration provisions
  523  in subsection (4) if:
  524         (a) The majority of the physicians who provide services in
  525  the clinic, facility, or office primarily provide surgical
  526  services;.
  527         (b) The clinic, facility or office is owned by a publicly
  528  held corporation whose shares are traded on a national exchange
  529  or on the over-the-counter market and whose total assets at the
  530  end of corporation’s most recent fiscal quarter exceeded $50
  531  million;
  532         (c) The clinic, facility or office is affiliated with an
  533  accredited medical school at which training is provided for
  534  medical students, residents, or fellows;
  535         (d) If the clinic does not prescribe or dispense controlled
  536  substances for the treatment of pain; or
  537         (e) The clinic, facility or office is owned by a corporate
  538  entity exempt from federal taxation under 26 U.S.C. s.
  539  501(c)(3).
  540         (8) The department shall adopt rules necessary to
  541  administer the registration and inspection of pain-management
  542  clinics establishing the specific requirements, procedures,
  543  forms, and fees.
  544         (9) The department shall adopt a rule defining what
  545  constitutes practice by a designated physician at the office
  546  location for which the physician has assumed responsibility, as
  547  set forth in subsections (3) and (4). When adopting the rule,
  548  the department shall consider the number of clinic employees,
  549  the location of the pain-management clinic, its hours of
  550  operation, and the amount of controlled substances being
  551  prescribed, dispensed, or administered at the pain-management
  552  clinic.
  553         (10) The Boards of Medicine and Osteopathic Medicine shall
  554  adopt a rule establishing the maximum number of prescriptions
  555  for Schedule II or Schedule III controlled substances which may
  556  be written at any one registered pain-management clinic during
  557  any 24-hour period.
  558         Section 7. Section 458.3265, Florida Statutes, is created
  559  to read:
  560         458.3265Pain-management clinics.—
  561         (1)(a) A physician may not practice medicine in a pain
  562  management clinic, as described in s. 458.309(4), if:
  563         1. Effective July 1, 2012, the physician has not
  564  successfully completed a pain medicine fellowship that is
  565  accredited by the Accreditation Council for Graduate Medical
  566  Education or a pain medicine residency that is accredited by the
  567  Accreditation Council for Graduate Medical Education unless
  568  previously registered and qualified as a pain medicine physician
  569  with the Board of Medicine; or
  570         2. The pain-management clinic is not registered with the
  571  department as required by s. 458.309. As provided in s.
  572  458.309(4), each location of a pain-management clinic must be
  573  registered separately regardless of whether the clinic is
  574  operated under the same business name or management as another
  575  clinic.
  576  
  577  The department may revoke the clinic’s certificate of
  578  registration and prohibit all physicians associated with that
  579  pain-management clinic from practicing at that office location
  580  based upon an annual inspection and evaluation of the factors
  581  described in s. 458.309(5)(a). A physician who violates this
  582  paragraph is subject to review by his or her appropriate medical
  583  regulatory board.
  584         (b)The department shall deny registration to any clinic
  585  not fully owned by a physician licensed pursuant to this chapter
  586  or chapter 459, a group of physicians licensed pursuant to this
  587  chapter or chapter 459, or a health care clinic licensed under
  588  part X of chapter 400.
  589         (c) The department shall deny registration to any pain
  590  management clinic owned by or with any contractual or employment
  591  relationship with a physician:
  592         1. Whose Drug Enforcement Administration number has ever
  593  been revoked.
  594         2. Whose application for a license to prescribe, dispense,
  595  or administer a controlled substance has been denied by any
  596  jurisdiction.
  597         3. Who has been convicted of or plead guilty or nolo
  598  contender to, regardless of adjudication, an offense that
  599  constitutes a felony for receipt of illicit and diverted drugs,
  600  including a controlled substance listed in Schedule I, Schedule
  601  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  602  this state, any other state, or the United States.
  603         (d) If the department finds that a pain-management clinic
  604  is owned , directly or indirectly, by a person meeting any
  605  criteria listed in paragraph (b) or paragraph (c), the
  606  department shall refuse to register the pain-management clinic
  607  or shall revoke the certificate of registration previously
  608  issued by the department. As determined by rule, the department
  609  may grant an exemption if more than 10 years have elapsed since
  610  adjudication. As used in this subsection, the term “convicted”
  611  includes an adjudication of guilt following a plea of guilty or
  612  nolo contendere or the forfeiture of a bond when charged with a
  613  crime.
  614         (2)A person may not dispense any medication, including a
  615  controlled substance, on the premises of a registered pain
  616  management clinic unless he or she is a physician licensed under
  617  this chapter or chapter 459.
  618         (3)After a physical examination of the patient the same
  619  day of dispensing a controlled substance, a physician must
  620  document in the patient’s record the reason for prescribing or
  621  dispensing more than a 72-hour dose of a controlled substance
  622  for the treatment of chronic nonmalignant pain.
  623         Section 8. Section 458.327, Florida Statutes, is amended to
  624  read:
  625         458.327 Penalty for violations.—
  626         (1) Each of the following acts constitutes a felony of the
  627  third degree, punishable as provided in s. 775.082, s. 775.083,
  628  or s. 775.084:
  629         (a) The practice of medicine or an attempt to practice
  630  medicine without a license to practice in Florida.
  631         (b) The use or attempted use of a license which is
  632  suspended or revoked to practice medicine.
  633         (c) Attempting to obtain or obtaining a license to practice
  634  medicine by knowing misrepresentation.
  635         (d) Attempting to obtain or obtaining a position as a
  636  medical practitioner or medical resident in a clinic or hospital
  637  through knowing misrepresentation of education, training, or
  638  experience.
  639         (e)Knowingly operating, owning, or managing a
  640  nonregistered pain-management clinic that is required to be
  641  registered with the Department of Health pursuant to
  642  s.458.309(4).
  643         (2) Each of the following acts constitutes a misdemeanor of
  644  the first degree, punishable as provided in s. 775.082 or s.
  645  775.083:
  646         (a) Knowingly concealing information relating to violations
  647  of this chapter.
  648         (b) Making any willfully false oath or affirmation whenever
  649  an oath or affirmation is required by this chapter.
  650         (c) Referring any patient, for health care goods or
  651  services, to a partnership, firm, corporation, or other business
  652  entity in which the physician or the physician’s employer has an
  653  equity interest of 10 percent or more unless, prior to such
  654  referral, the physician notifies the patient of his or her
  655  financial interest and of the patient’s right to obtain such
  656  goods or services at the location of the patient’s choice. This
  657  section does not apply to the following types of equity
  658  interest:
  659         1. The ownership of registered securities issued by a
  660  publicly held corporation or the ownership of securities issued
  661  by a publicly held corporation, the shares of which are traded
  662  on a national exchange or the over-the-counter market;
  663         2. A physician’s own practice, whether he or she is a sole
  664  practitioner or part of a group, when the health care good or
  665  service is prescribed or provided solely for the physician’s own
  666  patients and is provided or performed by the physician or under
  667  the physician’s supervision; or
  668         3. An interest in real property resulting in a landlord
  669  tenant relationship between the physician and the entity in
  670  which the equity interest is held, unless the rent is
  671  determined, in whole or in part, by the business volume or
  672  profitability of the tenant or is otherwise unrelated to fair
  673  market value.
  674         (d) Leading the public to believe that one is licensed as a
  675  medical doctor, or is engaged in the licensed practice of
  676  medicine, without holding a valid, active license.
  677         (e) Practicing medicine or attempting to practice medicine
  678  with an inactive or delinquent license.
  679         (f) Knowingly prescribing or dispensing, or causing to be
  680  prescribed or dispensed, controlled substances in a
  681  nonregistered pain-management clinic that is required to be
  682  registered with the Department of Health pursuant to s.
  683  458.309(4).
  684         Section 9. Section 459.005, Florida Statutes, is amended to
  685  read:
  686         459.005 Rulemaking authority.—
  687         (1) The board has authority to adopt rules pursuant to ss.
  688  120.536(1) and 120.54 to implement the provisions of this
  689  chapter conferring duties upon it.
  690         (2) All physicians who perform level 2 procedures lasting
  691  more than 5 minutes and all level 3 surgical procedures in an
  692  office setting must register the office with the department
  693  unless that office is licensed as a facility pursuant to chapter
  694  395. The department shall inspect the physician’s office
  695  annually unless the office is accredited by a nationally
  696  recognized accrediting agency or an accrediting organization
  697  subsequently approved by the Board of Osteopathic Medicine. The
  698  actual costs for registration and inspection or accreditation
  699  shall be paid by the person seeking to register and operate the
  700  office setting in which office surgery is performed.
  701         (3) Effective January 4, 2010, all privately owned pain
  702  management clinics, facilities, or offices, hereinafter referred
  703  to as “clinics,” which advertise in any medium for any type of
  704  pain-management services, or employ a physician who is licensed
  705  under this chapter and who is primarily engaged in the treatment
  706  of pain by prescribing or dispensing controlled substance
  707  medications, must register with the department by January 4,
  708  2010, unless that clinic is licensed as a facility under chapter
  709  395. A physician may not practice osteopathic medicine in a
  710  pain-management clinic that is required to but has not
  711  registered with the department. Each clinic location shall be
  712  registered separately regardless of whether the clinic is
  713  operated under the same business name or management as another
  714  clinic. If the clinic is licensed as a health care clinic under
  715  chapter 400, the medical director is responsible for registering
  716  the facility with the department. If the clinic is not
  717  registered under chapter 395 or chapter 400, the clinic shall,
  718  upon registration with the department, designate a physician who
  719  is responsible for complying with all requirements related to
  720  registration of the clinic. The designated physician shall have
  721  a full, active, and unencumbered license be licensed under
  722  chapter 458 or this chapter and shall practice at the office
  723  location for which the physician has assumed responsibility. The
  724  department shall inspect the clinic annually, including a review
  725  of the patient records, to ensure that it complies with rules of
  726  the Board of Osteopathic Medicine adopted pursuant to this
  727  subsection and subsection (4) unless the office is accredited by
  728  a nationally recognized accrediting agency approved by the Board
  729  of Osteopathic Medicine. The actual costs for registration and
  730  inspection or accreditation shall be paid by the physician
  731  seeking to register the clinic.
  732         (4) The Board of Osteopathic Medicine shall adopt rules
  733  setting forth standards of practice for physicians who practice
  734  in privately owned pain-management clinics that primarily engage
  735  in the treatment of pain by prescribing or dispensing controlled
  736  substance medications. Such rules shall address, but need not be
  737  limited to, the following subjects:
  738         (a) Facility operations;
  739         (b) Physical operations;
  740         (c) Infection control requirements;
  741         (d) Health and safety requirements;
  742         (e) Quality assurance requirements;
  743         (f) Patient records;
  744         (g) Training requirements for all facility health care
  745  practitioners who are not regulated by another board;
  746         (h) Inspections; and
  747         (i) Data collection and reporting requirements.
  748  
  749  A physician is primarily engaged in the treatment of pain by
  750  prescribing or dispensing controlled substance medications when
  751  the majority of the patients seen are prescribed or dispensed
  752  controlled substance medications for the treatment of chronic
  753  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  754  to cancer which persists beyond the usual course of the disease
  755  or the injury that is the cause of the pain or more than 90 days
  756  after surgery.
  757         (5) A privately owned clinic, facility, or office that
  758  advertises in any medium for any type of pain-management
  759  services or employs one or more physicians who are primarily
  760  engaged in the treatment of pain by prescribing or dispensing
  761  controlled substances is exempt from the registration provisions
  762  in subsection (3) if:
  763         (a) The majority of the physicians who provide services in
  764  the clinic, facility, or office primarily provide surgical
  765  services;.
  766         (b) The clinic, facility or office is owned by a publicly
  767  held corporation whose shares are traded on a national exchange
  768  or on the over-the-counter market and whose total assets at the
  769  end of corporation’s most recent fiscal quarter exceeded $50
  770  million;
  771         (c) The clinic, facility or office is affiliated with an
  772  accredited medical school at which training is provided for
  773  medical students, residents, or fellows;
  774         (d) If the clinic does not prescribe or dispense controlled
  775  substances for the treatment of pain; or
  776         (e) The clinic, facility or office is owned by a corporate
  777  entity exempt from federal taxation under 26 U.S.C. s.
  778  501(c)(3).
  779         (6)(a)The department may deny an application for
  780  registering a pain-management clinic or revoke or suspend a
  781  current registration. The department may impose an
  782  administrative fine on the clinic of up to $5,000 per violation
  783  for violating the requirements of this section, chapter 499, the
  784  Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  785  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  786  the Drug Abuse Prevention and Control Act; or chapter 893, the
  787  Florida Comprehensive Drug Abuse Prevention and Control Act; or
  788  the rules of the department. In determining whether a penalty is
  789  to be imposed, and in fixing the amount of the fine, the
  790  department shall consider the following factors:
  791         1. The gravity of the violation, including the probability
  792  that death or serious physical or emotional harm to a patient
  793  has resulted, or could have resulted, from a licensee’s actions,
  794  the severity of the action or potential harm, and the extent to
  795  which the provisions of the applicable laws or rules were
  796  violated.
  797         2. What actions, if any, the owner or designated physician
  798  took to correct the violations.
  799         3. Whether there were any previous violations at the pain
  800  management clinic.
  801         4. The financial benefits that the pain-management clinic
  802  derived from committing or continuing to commit the violation.
  803         (b) Each day a violation continues after the date fixed for
  804  termination as ordered by the department, constitutes an
  805  additional, separate, and distinct violation.
  806         (c) Any action taken to correct a violation shall be
  807  documented in writing by the owner or designated physician of
  808  the pain-management clinic and verified by followup visits by
  809  departmental personnel. The department may impose a fine and, in
  810  the case of an owner-operated pain-management clinic may revoke
  811  or deny a clinic’s registration, if the clinic’s designated
  812  physician knowingly and intentionally misrepresents actions
  813  taken to correct a violation.
  814         (d) An owner or designated physician of a pain-management
  815  clinic who concurrently operates an unregistered pain-management
  816  clinic is subject to an administrative fine of $5,000 per day.
  817         (e) If the owner of a pain-management clinic fails to apply
  818  for a change-of-ownership registration and operates the clinic
  819  under the new ownership, the owner is subject to a fine of
  820  $5,000.
  821         (f) During an onsite inspection, the department shall make
  822  a reasonable attempt to discuss each violation with the owner or
  823  designated physician of the pain-management clinic before
  824  issuing a formal written notification.
  825         (g)1.If the registration of a pain-management clinic is
  826  revoked or suspended, the designated physician of the pain
  827  management clinic, the owner or lessor of the pain-management
  828  clinic property, and the owner, manager, or proprietor shall
  829  cease to operate the facility as a pain-management clinic as of
  830  the effective date of the suspension or revocation.
  831         2.If a pain-management clinic’s registration is revoked or
  832  suspended, the designated physician of the pain-management
  833  clinic, the owner or lessor of the clinic property, or the
  834  owner, manager, or proprietor is responsible for removing all
  835  signs and symbols identifying the premises as a pain-management
  836  clinic.
  837         3.If the clinic’s registration is revoked, any person
  838  named in the registration documents of the pain-management
  839  clinic, including persons owning or operating the pain
  840  management clinic, may not, as an individual or as a part of a
  841  group, apply to operate a pain-management clinic for 5 years
  842  after the date the registration is revoked.
  843         4.Upon the effective date of the suspension or revocation,
  844  the pain-management clinic shall advise the department of the
  845  disposition of the medicinal drugs located on the premises. The
  846  disposition is subject to the supervision and approval of the
  847  department. Medicinal drugs that are purchased or held by a
  848  pain–management clinic that is not registered may be deemed
  849  adulterated pursuant to s. 499.006.
  850         5.The period of the suspension shall be prescribed by the
  851  department, but may not exceed 1 year.
  852         (7) The department shall adopt rules necessary to
  853  administer the registration and inspection of pain-management
  854  clinics establishing the specific requirements, procedures,
  855  forms, and fees.
  856         (8) The department shall adopt a rule defining what
  857  constitutes practice by a designated physician at the office
  858  location for which the physician has assumed responsibility, as
  859  set forth in subsections (3) and (4). When adopting the rule,
  860  the department shall consider the number of clinic employees,
  861  the location of the pain-management clinic, its hours of
  862  operation, and the amount of controlled substances being
  863  prescribed, dispensed, or administered at the pain-management
  864  clinic.
  865         (9) The Boards of Medicine and Osteopathic Medicine shall
  866  adopt a rule establishing the maximum number of prescriptions
  867  for Schedule II or Schedule III controlled substances which may
  868  can be written at any one registered pain-management clinic
  869  during any 24-hour period.
  870         Section 10. Section 459.0137, Florida Statutes, is created
  871  to read:
  872         459.0137Pain-management clinics.—
  873         (1)(a)An osteopathic physician may not practice
  874  osteopathic medicine in a pain-management clinic, as described
  875  in s. 459.005(3), if:
  876         1.Effective July 1, 2012, the physician has not
  877  successfully completed a pain medicine fellowship that is
  878  accredited by the Accreditation Council for Graduate Medical
  879  Education or the American Osteopathic Association or a pain
  880  medicine residency that is accredited by the Accreditation
  881  Council for Graduate Medical Education or the American
  882  Osteopathic Association unless previously registered and
  883  qualified as a pain medicine physician with the Board of
  884  Osteopathic Medicine; or
  885         2. The pain-management clinic is not registered with the
  886  department as required by s. 459.005. As provided in s.
  887  459.005(3), each location of a pain-management clinic must be
  888  registered separately regardless of whether the clinic is
  889  operated under the same business name or management as another
  890  clinic.
  891  
  892  The department may revoke the clinic’s certificate of
  893  registration and prohibit all physicians associated with that
  894  pain-management clinic from practicing at that office location
  895  based upon an annual inspection and evaluation of the factors
  896  described in s. 459.005(6)(a). A physician who violates this
  897  paragraph is subject to review by his or her appropriate medical
  898  regulatory board.
  899         (b)The department shall deny registration to any clinic
  900  not fully owned by a physician licensed pursuant to chapter 458
  901  or this chapter, a group of physicians licensed pursuant to
  902  chapter 458 or this chapter, or a health care clinic licensed
  903  under part X of chapter 400.
  904         (c) The department shall deny registration to any pain
  905  management clinic owned by or with any contractual or employment
  906  relationship with a physician:
  907         1. Whose Drug Enforcement Administration number has ever
  908  been revoked;
  909         2. Whose application for a license to prescribe, dispense,
  910  or administer a controlled substance has been denied by any
  911  jurisdiction; or
  912         3. Who has been convicted of or plead guilty or nolo
  913  contender to, regardless of adjudication, an offense that
  914  constitutes a felony for receipt of illicit and diverted drugs,
  915  including a controlled substance listed in Schedule I, Schedule
  916  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  917  this state, any other state, or the United States.
  918         (d) If the department finds that a pain-management clinic
  919  is owned, directly or indirectly, by a person meeting any
  920  criteria listed in paragraph (b) or paragraph (c), the
  921  department shall refuse to register the pain-management clinic
  922  or shall revoke the certificate of registration previously
  923  issued by the department. As determined by rule, the department
  924  may grant an exemption if more than 10 years have elapsed since
  925  adjudication. As used in this subsection, the term “convicted”
  926  includes an adjudication of guilt following a plea of guilty or
  927  nolo contendere or the forfeiture of a bond when charged with a
  928  crime.
  929         (2)A person may not dispense any medication, including a
  930  controlled substance, on the premises of a registered pain
  931  management clinic unless he or she is a physician licensed under
  932  this chapter or chapter 458.
  933         (3)After a physical examination of the patient the same
  934  day of dispensing a controlled substance, a physician must
  935  document in the patient’s record the reason for prescribing or
  936  dispensing more than a 72-hour dose of a controlled substance
  937  for the treatment of chronic nonmalignant pain.
  938         Section 11. Subsections (1) and (2) of section 459.013,
  939  Florida Statutes, are amended to read:
  940         459.013 Penalty for violations.—
  941         (1) Each of the following acts constitutes a felony of the
  942  third degree, punishable as provided in s. 775.082, s. 775.083,
  943  or s. 775.084:
  944         (a) The practice of osteopathic medicine, or an attempt to
  945  practice osteopathic medicine, without an active license or
  946  certificate issued pursuant to this chapter.
  947         (b) The practice of osteopathic medicine by a person
  948  holding a limited license, osteopathic faculty certificate, or
  949  other certificate issued under this chapter beyond the scope of
  950  practice authorized for such licensee or certificateholder.
  951         (c) Attempting to obtain or obtaining a license to practice
  952  osteopathic medicine by knowing misrepresentation.
  953         (d) Attempting to obtain or obtaining a position as an
  954  osteopathic medical practitioner or osteopathic medical resident
  955  in a clinic or hospital through knowing misrepresentation of
  956  education, training, or experience.
  957         (e)Knowingly operating, owning, or managing a
  958  nonregistered pain-management clinic that is required to be
  959  registered with the Department of Health pursuant to s.
  960  459.005(3).
  961         (2) Each of the following acts constitutes a misdemeanor of
  962  the first degree, punishable as provided in s. 775.082 or s.
  963  775.083:
  964         (a) Knowingly concealing information relating to violations
  965  of this chapter.
  966         (b) Making any willfully false oath or affirmation whenever
  967  an oath or affirmation is required by this chapter.
  968         (c) The practice of medicine as a resident or intern
  969  without holding a valid current registration pursuant to s.
  970  459.021.
  971         (d) Knowingly prescribing or dispensing, or causing to be
  972  prescribed or dispensed, controlled substances in a
  973  nonregistered pain-management clinic that is required to be
  974  registered with the Department of Health pursuant to s.
  975  459.005(3).
  976         Section 12. This act shall take effect July 1, 2010.

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