August 31, 2016
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       ENROLLED
       2010 Legislature     CS for CS for SB 2272 & CS for SB 2722, 2nd
                                                              Engrossed
       
       
       
       
       
                                                             20102272er
    1  
    2         An act relating to controlled substances; amending s.
    3         456.037, F.S.; providing that pain-management clinics
    4         that are required to be registered with the Department
    5         of Health are business establishments; amending s.
    6         456.057, F.S.; providing that the Department of Health
    7         is not required to attempt to obtain authorization
    8         from a patient for the release of the patient’s
    9         medical records under certain circumstances;
   10         authorizing the department to obtain patient records
   11         without authorization or subpoena if the department
   12         has probable cause to believe that certain violations
   13         have occurred or are occurring; repealing s.
   14         458.309(4), (5), and (6), F.S., relating to pain
   15         management clinics; creating s. 458.3265, F.S.;
   16         requiring all privately owned pain-management clinics,
   17         or offices that primarily engage in the treatment of
   18         pain by prescribing or dispensing controlled substance
   19         medications or by employing a physician who is
   20         primarily engaged in the treatment of pain by
   21         prescribing or dispensing controlled substance
   22         medications, to register with the Department of
   23         Health; providing exceptions; requiring each location
   24         of a pain-management clinic to register separately;
   25         requiring a clinic to designate a physician who is
   26         responsible for complying with requirements related to
   27         registration and operation of the clinic; requiring
   28         the department to deny registration or revoke the
   29         registration of a pain-management clinic for certain
   30         conditions; authorizing the department to revoke a
   31         clinic’s certificate of registration and prohibit
   32         physicians associated with the clinic from practicing
   33         at the clinic’s location; requiring a pain-management
   34         clinic to cease operating if its registration
   35         certificate is revoked or suspended; requiring certain
   36         named persons to remove all signs and symbols
   37         identifying the premises as a pain-management clinic;
   38         requiring a pain-management clinic that has had its
   39         registration revoked or suspended to advise the
   40         department of the disposition of the medicinal drugs
   41         located on the premises; providing that medicinal
   42         drugs that are purchased or held by a pain–management
   43         clinic that is not registered may be deemed
   44         adulterated; prohibiting any person acting as an
   45         individual or as part of a group from applying for a
   46         certificate to operate a pain-management clinic for a
   47         certain period after the date the person’s
   48         registration certificate is revoked; providing that a
   49         change of ownership of a registered pain-management
   50         clinic requires submission of a new registration
   51         application; providing the responsibilities of a
   52         physician who provides professional services at a
   53         pain-management clinic; requiring the department to
   54         inspect pain-management clinics and its patient
   55         records; providing an exception to inspection by the
   56         department; requiring a pain-management clinic to
   57         document corrective action; requiring the department
   58         and the Board of Medicine to adopt rules; authorizing
   59         the department to impose fines, deny a clinic’s
   60         registration, or revoke a clinic’s registration;
   61         amending s. 458.327, F.S.; providing that the
   62         commission of certain specified acts involving a
   63         nonregistered pain-management clinic constitutes a
   64         felony of the third degree or a misdemeanor of the
   65         first degree; amending s. 458.331, F.S.; providing
   66         additional acts that constitute grounds for
   67         disciplinary actions against health professional
   68         licensees; repealing s. 459.005(3), (4), and (5),
   69         F.S., relating to pain-management clinics; creating s.
   70         459.0137, F.S.; requiring all privately owned pain
   71         management clinics, or offices that primarily engage
   72         in the treatment of pain by prescribing or dispensing
   73         controlled substance medications or by employing an
   74         osteopathic physician who is primarily engaged in the
   75         treatment of pain by prescribing or dispensing
   76         controlled substance medications, to register with the
   77         department; providing exceptions; requiring each
   78         location of a pain-management clinic to register
   79         separately; requiring a clinic to designate an
   80         osteopathic physician who is responsible for complying
   81         with requirements related to registration and
   82         operation of the clinic; requiring the department to
   83         deny registration or revoke the registration of a
   84         pain-management clinic for certain conditions;
   85         authorizing the department to revoke a clinic’s
   86         certificate of registration and prohibit osteopathic
   87         physicians associated with the clinic from practicing
   88         at the clinic’s location; requiring a pain-management
   89         clinic to cease operating if its registration
   90         certificate is revoked or suspended; requiring certain
   91         named persons to remove all signs and symbols
   92         identifying the premises as a pain-management clinic;
   93         requiring a pain-management clinic that has had its
   94         registration revoked or suspended to advise the
   95         department of the disposition of the medicinal drugs
   96         located on the premises; providing that medicinal
   97         drugs that are purchased or held by a pain–management
   98         clinic that is not registered may be deemed
   99         adulterated; prohibiting any person acting as an
  100         individual or as part of a group from applying for a
  101         certificate to operate a pain-management clinic for a
  102         certain period after the date the person’s
  103         registration certificate is revoked; providing that a
  104         change of ownership of a registered pain-management
  105         clinic requires submission of a new registration
  106         application; providing the responsibilities of an
  107         osteopathic physician who provides professional
  108         services at a pain-management clinic; requiring the
  109         department to inspect pain-management clinics and its
  110         patient records; providing an exception to inspection
  111         by the department; requiring a pain-management clinic
  112         to document corrective action; requiring the
  113         department and the Board of Osteopathic Medicine to
  114         adopt rules; authorizing the department to impose
  115         fines, deny a clinic’s registration, or revoke a
  116         clinic’s registration; amending s. 459.013, F.S.;
  117         providing that the commission of certain specified
  118         acts involving a nonregistered pain-management clinic
  119         constitutes a felony of the third degree or a
  120         misdemeanor of the first degree; amending s. 459.015,
  121         F.S.; providing additional acts that constitute
  122         grounds for disciplinary actions against health
  123         professional licensees; amending s. 465.0276, F.S.;
  124         prohibiting registered dispensing practitioners from
  125         dispensing more than a specified amount of certain
  126         controlled substances; providing penalties; providing
  127         exceptions; amending s. 893.055, F.S.; defining the
  128         term “program manager”; requiring that the program
  129         manager work with certain licensure boards and
  130         stakeholders to develop rules; authorizing the program
  131         manager to provide relevant information to law
  132         enforcement agencies under certain circumstances;
  133         amending s. 893.0551, F.S.; providing for disclosure
  134         of confidential and exempt information to applicable
  135         law enforcement; providing an effective date.
  136  
  137  Be It Enacted by the Legislature of the State of Florida:
  138  
  139         Section 1. Subsection (5) of section 456.037, Florida
  140  Statutes, is amended to read:
  141         456.037 Business establishments; requirements for active
  142  status licenses; delinquency; discipline; applicability.—
  143         (5) This section applies to any business establishment
  144  registered, permitted, or licensed by the department to do
  145  business. Business establishments include, but are not limited
  146  to, dental laboratories, electrology facilities, massage
  147  establishments, and pharmacies, and pain-management clinics
  148  required to be registered under s. 458.3265 or s. 459.0137.
  149         Section 2. Paragraph (a) of subsection (9) of section
  150  456.057, Florida Statutes, is amended to read:
  151         456.057 Ownership and control of patient records; report or
  152  copies of records to be furnished.—
  153         (9)(a)1. The department may obtain patient records pursuant
  154  to a subpoena without written authorization from the patient if
  155  the department and the probable cause panel of the appropriate
  156  board, if any, find reasonable cause to believe that a health
  157  care practitioner has excessively or inappropriately prescribed
  158  any controlled substance specified in chapter 893 in violation
  159  of this chapter or any professional practice act or that a
  160  health care practitioner has practiced his or her profession
  161  below that level of care, skill, and treatment required as
  162  defined by this chapter or any professional practice act and
  163  also find that appropriate, reasonable attempts were made to
  164  obtain a patient release. Notwithstanding the foregoing, the
  165  department need not attempt to obtain a patient release when
  166  investigating an offense involving the inappropriate
  167  prescribing, overprescribing, or diversion of controlled
  168  substances and the offense involves a pain-management clinic.
  169  The department may obtain patient records without patient
  170  authorization or subpoena from any pain-management clinic
  171  required to be licensed if the department has probable cause to
  172  believe that a violation of any provision of s. 458.3265 or s.
  173  459.0137 is occurring or has occurred and reasonably believes
  174  that obtaining such authorization is not feasible due to the
  175  volume of the dispensing and prescribing activity involving
  176  controlled substances and that obtaining patient authorization
  177  or the issuance of a subpoena would jeopardize the
  178  investigation.
  179         2. The department may obtain patient records and insurance
  180  information pursuant to a subpoena without written authorization
  181  from the patient if the department and the probable cause panel
  182  of the appropriate board, if any, find reasonable cause to
  183  believe that a health care practitioner has provided inadequate
  184  medical care based on termination of insurance and also find
  185  that appropriate, reasonable attempts were made to obtain a
  186  patient release.
  187         3. The department may obtain patient records, billing
  188  records, insurance information, provider contracts, and all
  189  attachments thereto pursuant to a subpoena without written
  190  authorization from the patient if the department and probable
  191  cause panel of the appropriate board, if any, find reasonable
  192  cause to believe that a health care practitioner has submitted a
  193  claim, statement, or bill using a billing code that would result
  194  in payment greater in amount than would be paid using a billing
  195  code that accurately describes the services performed, requested
  196  payment for services that were not performed by that health care
  197  practitioner, used information derived from a written report of
  198  an automobile accident generated pursuant to chapter 316 to
  199  solicit or obtain patients personally or through an agent
  200  regardless of whether the information is derived directly from
  201  the report or a summary of that report or from another person,
  202  solicited patients fraudulently, received a kickback as defined
  203  in s. 456.054, violated the patient brokering provisions of s.
  204  817.505, or presented or caused to be presented a false or
  205  fraudulent insurance claim within the meaning of s.
  206  817.234(1)(a), and also find that, within the meaning of s.
  207  817.234(1)(a), patient authorization cannot be obtained because
  208  the patient cannot be located or is deceased, incapacitated, or
  209  suspected of being a participant in the fraud or scheme, and if
  210  the subpoena is issued for specific and relevant records.
  211         4. Notwithstanding subparagraphs 1.-3., when the department
  212  investigates a professional liability claim or undertakes action
  213  pursuant to s. 456.049 or s. 627.912, the department may obtain
  214  patient records pursuant to a subpoena without written
  215  authorization from the patient if the patient refuses to
  216  cooperate or if the department attempts to obtain a patient
  217  release and the failure to obtain the patient records would be
  218  detrimental to the investigation.
  219         Section 3. Subsections (4), (5), and (6) of section
  220  458.309, Florida Statutes, are repealed.
  221         Section 4. Section 458.3265, Florida Statutes, is created
  222  to read:
  223         458.3265Pain-management clinics.—
  224         (1)REGISTRATION.—
  225         (a) All privately owned pain-management clinics,
  226  facilities, or offices, hereinafter referred to as “clinics,”
  227  which advertise in any medium for any type of pain-management
  228  services, or employ a physician who is primarily engaged in the
  229  treatment of pain by prescribing or dispensing controlled
  230  substance medications, must register with the department unless:
  231         1. That clinic is licensed as a facility pursuant to
  232  chapter 395;
  233         2. The majority of the physicians who provide services in
  234  the clinic primarily provide surgical services;
  235         3.The clinic is owned by a publicly held corporation whose
  236  shares are traded on a national exchange or on the over-the
  237  counter market and whose total assets at the end of the
  238  corporation’s most recent fiscal quarter exceeded $50 million;
  239         4. The clinic is affiliated with an accredited medical
  240  school at which training is provided for medical students,
  241  residents, or fellows;
  242         5. The clinic does not prescribe or dispense controlled
  243  substances for the treatment of pain; or
  244         6. The clinic is owned by a corporate entity exempt from
  245  federal taxation under 26 U.S.C. s. 501(c)(3).
  246         (b) Each clinic location shall be registered separately
  247  regardless of whether the clinic is operated under the same
  248  business name or management as another clinic.
  249         (c) As a part of registration, a clinic must designate a
  250  physician who is responsible for complying with all requirements
  251  related to registration and operation of the clinic in
  252  compliance with this section. Within 10 days after termination
  253  of a designated physician, the clinic must notify the department
  254  of the identity of another designated physician for that clinic.
  255  The designated physician shall have a full, active, and
  256  unencumbered license under this chapter or chapter 459 and shall
  257  practice at the clinic location for which the physician has
  258  assumed responsibility. Failing to have a licensed designated
  259  physician practicing at the location of the registered clinic
  260  may be the basis for a summary suspension of the clinic
  261  registration certificate as described in s. 456.073(8) for a
  262  license or s. 120.60(6).
  263         (d)The department shall deny registration to any clinic
  264  that is not fully owned by a physician licensed under this
  265  chapter or chapter 459 or a group of physicians, each of whom is
  266  licensed under this chapter or chapter 459; or that is not a
  267  health care clinic licensed under part X of chapter 400.
  268         (e) The department shall deny registration to any pain
  269  management clinic owned by or with any contractual or employment
  270  relationship with a physician:
  271         1. Whose Drug Enforcement Administration number has ever
  272  been revoked.
  273         2. Whose application for a license to prescribe, dispense,
  274  or administer a controlled substance has been denied by any
  275  jurisdiction.
  276         3. Who has been convicted of or plead guilty or nolo
  277  contendere to, regardless of adjudication, an offense that
  278  constitutes a felony for receipt of illicit and diverted drugs,
  279  including a controlled substance listed in Schedule I, Schedule
  280  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  281  this state, any other state, or the United States.
  282         (f) If the department finds that a pain-management clinic
  283  does not meet the requirement of paragraph (d) or is owned,
  284  directly or indirectly, by a person meeting any criteria listed
  285  in paragraph (e), the department shall revoke the certificate of
  286  registration previously issued by the department. As determined
  287  by rule, the department may grant an exemption to denying a
  288  registration or revoking a previously issued registration if
  289  more than 10 years have elapsed since adjudication. As used in
  290  this subsection, the term “convicted” includes an adjudication
  291  of guilt following a plea of guilty or nolo contendere or the
  292  forfeiture of a bond when charged with a crime.
  293         (g) The department may revoke the clinic’s certificate of
  294  registration and prohibit all physicians associated with that
  295  pain-management clinic from practicing at that clinic location
  296  based upon an annual inspection and evaluation of the factors
  297  described in subsection (3).
  298         (h)If the registration of a pain-management clinic is
  299  revoked or suspended, the designated physician of the pain
  300  management clinic, the owner or lessor of the pain-management
  301  clinic property, the manager, and the proprietor shall cease to
  302  operate the facility as a pain-management clinic as of the
  303  effective date of the suspension or revocation.
  304         (i)If a pain-management clinic registration is revoked or
  305  suspended, the designated physician of the pain-management
  306  clinic, the owner or lessor of the clinic property, the manager,
  307  or the proprietor is responsible for removing all signs and
  308  symbols identifying the premises as a pain-management clinic.
  309         (j)Upon the effective date of the suspension or
  310  revocation, the designated physician of the pain-management
  311  clinic shall advise the department of the disposition of the
  312  medicinal drugs located on the premises. The disposition is
  313  subject to the supervision and approval of the department.
  314  Medicinal drugs that are purchased or held by a pain–management
  315  clinic that is not registered may be deemed adulterated pursuant
  316  to s. 499.006.
  317         (k)If the clinic’s registration is revoked, any person
  318  named in the registration documents of the pain-management
  319  clinic, including persons owning or operating the pain
  320  management clinic, may not, as an individual or as a part of a
  321  group, apply to operate a pain-management clinic for 5 years
  322  after the date the registration is revoked.
  323         (l)The period of suspension for the registration of a pain
  324  management clinic shall be prescribed by the department, but may
  325  not exceed 1 year.
  326         (m) A change of ownership of a registered pain-management
  327  clinic requires submission of a new registration application.
  328         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  329  apply to any physician who provides professional services in a
  330  pain-management clinic that is required to be registered in
  331  subsection (1).
  332         (a)A physician may not practice medicine in a pain
  333  management clinic, as described in subsection (4), if:
  334         1.The pain-management clinic is not registered with the
  335  department as required by this section; or
  336         2.Effective July 1, 2012, the physician has not
  337  successfully completed a pain medicine fellowship that is
  338  accredited by the Accreditation Council for Graduate Medical
  339  Education or a pain medicine residency that is accredited by the
  340  Accreditation Council for Graduate Medical Education or, prior
  341  to July 1, 2012, does not comply with rules adopted by the
  342  board.
  343  
  344  Any physician who qualifies to practice medicine in a pain
  345  management clinic pursuant to rules adopted by the Board of
  346  Medicine as of July 1, 2012, may continue to practice medicine
  347  in a pain-management clinic as long as the physician continues
  348  to meet the qualifications set forth in the board rules. A
  349  physician who violates this paragraph is subject to disciplinary
  350  action by his or her appropriate medical regulatory board.
  351         (b)A person may not dispense any medication, including a
  352  controlled substance, on the premises of a registered pain
  353  management clinic unless he or she is a physician licensed under
  354  this chapter or chapter 459.
  355         (c)A physician must perform a physical examination of a
  356  patient on the same day that he or she dispenses or prescribes a
  357  controlled substance to a patient at a pain-management clinic.
  358  If the physician prescribes or dispenses more than a 72-hour
  359  dose of controlled substances for the treatment of chronic
  360  nonmalignant pain, the physician must document in the patient’s
  361  record the reason for prescribing or dispensing that quantity.
  362         (d) A physician authorized to prescribe controlled
  363  substances who practices at a pain-management clinic is
  364  responsible for maintaining the control and security of his or
  365  her prescription blanks and any other method used for
  366  prescribing controlled substance pain medication. The physician
  367  shall comply with the requirements for counterfeit-resistant
  368  prescription blanks in s. 893.065 and the rules adopted pursuant
  369  to that section. The physician shall notify in writing the
  370  department within 24 hours following any theft or loss of a
  371  prescription blank or breach of any other method for prescribing
  372  pain medication.
  373         (e)The designated physician of a pain-management clinic
  374  shall notify the applicable board in writing of the date of
  375  termination of employment within 10 days after terminating his
  376  or her employment with a pain-management clinic that is required
  377  to be registered under subsection (1).
  378         (3) INSPECTION.—
  379         (a) The department shall inspect the pain-management clinic
  380  annually, including a review of the patient records, to ensure
  381  that it complies with this section and the rules of the Board of
  382  Medicine adopted pursuant to subsection (4) unless the clinic is
  383  accredited by a nationally recognized accrediting agency
  384  approved by the Board of Medicine.
  385         (b) During an onsite inspection, the department shall make
  386  a reasonable attempt to discuss each violation with the owner or
  387  designated physician of the pain-management clinic before
  388  issuing a formal written notification.
  389         (c) Any action taken to correct a violation shall be
  390  documented in writing by the owner or designated physician of
  391  the pain-management clinic and verified by followup visits by
  392  departmental personnel.
  393         (4) RULEMAKING.—
  394         (a) The department shall adopt rules necessary to
  395  administer the registration and inspection of pain-management
  396  clinics which establish the specific requirements, procedures,
  397  forms, and fees.
  398         (b) The department shall adopt a rule defining what
  399  constitutes practice by a designated physician at the clinic
  400  location for which the physician has assumed responsibility, as
  401  set forth in subsection (1). When adopting the rule, the
  402  department shall consider the number of clinic employees, the
  403  location of the pain-management clinic, the clinic’s hours of
  404  operation, and the amount of controlled substances being
  405  prescribed, dispensed, or administered at the pain-management
  406  clinic.
  407         (c) The Board of Medicine shall adopt a rule establishing
  408  the maximum number of prescriptions for Schedule II or Schedule
  409  III controlled substances or the controlled substance Alprazolam
  410  which may be written at any one registered pain-management
  411  clinic during any 24-hour period.
  412         (d)The Board of Medicine shall adopt rules setting forth
  413  standards of practice for physicians practicing in privately
  414  owned pain-management clinics that primarily engage in the
  415  treatment of pain by prescribing or dispensing controlled
  416  substance medications. Such rules shall address, but need not be
  417  limited to:
  418         1.Facility operations;
  419         2.Physical operations;
  420         3.Infection control requirements;
  421         4.Health and safety requirements;
  422         5.Quality assurance requirements;
  423         6.Patient records;
  424         7.Training requirements for all facility health care
  425  practitioners who are not regulated by another board;
  426         8.Inspections; and
  427         9.Data collection and reporting requirements.
  428  
  429  A physician is primarily engaged in the treatment of pain by
  430  prescribing or dispensing controlled substance medications when
  431  the majority of the patients seen are prescribed or dispensed
  432  controlled substance medications for the treatment of chronic
  433  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  434  to cancer which persists beyond the usual course of the disease
  435  or the injury that is the cause of the pain or more than 90 days
  436  after surgery.
  437         (5) PENALTIES; ENFORCEMENT.—
  438         (a)The department may impose an administrative fine on the
  439  clinic of up to $5,000 per violation for violating the
  440  requirements of this section; chapter 499, the Florida Drug and
  441  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  442  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  443  Abuse Prevention and Control Act; chapter 893, the Florida
  444  Comprehensive Drug Abuse Prevention and Control Act; or the
  445  rules of the department. In determining whether a penalty is to
  446  be imposed, and in fixing the amount of the fine, the department
  447  shall consider the following factors:
  448         1. The gravity of the violation, including the probability
  449  that death or serious physical or emotional harm to a patient
  450  has resulted, or could have resulted, from the pain-management
  451  clinic’s actions or the actions of the physician, the severity
  452  of the action or potential harm, and the extent to which the
  453  provisions of the applicable laws or rules were violated.
  454         2. What actions, if any, the owner or designated physician
  455  took to correct the violations.
  456         3. Whether there were any previous violations at the pain
  457  management clinic.
  458         4. The financial benefits that the pain-management clinic
  459  derived from committing or continuing to commit the violation.
  460         (b) Each day a violation continues after the date fixed for
  461  termination of the violation as ordered by the department
  462  constitutes an additional, separate, and distinct violation.
  463         (c) The department may impose a fine and, in the case of an
  464  owner-operated pain-management clinic, revoke or deny a pain
  465  management clinic’s registration, if the clinic’s designated
  466  physician knowingly and intentionally misrepresents actions
  467  taken to correct a violation.
  468         (d) An owner or designated physician of a pain-management
  469  clinic who concurrently operates an unregistered pain-management
  470  clinic is subject to an administrative fine of $5,000 per day.
  471         (e) If the owner of a pain-management clinic that requires
  472  registration fails to apply to register the clinic upon a
  473  change-of-ownership and operates the clinic under the new
  474  ownership, the owner is subject to a fine of $5,000.
  475         Section 5. Section 458.327, Florida Statutes, is amended to
  476  read:
  477         458.327 Penalty for violations.—
  478         (1) Each of the following acts constitutes a felony of the
  479  third degree, punishable as provided in s. 775.082, s. 775.083,
  480  or s. 775.084:
  481         (a) The practice of medicine or an attempt to practice
  482  medicine without a license to practice in Florida.
  483         (b) The use or attempted use of a license which is
  484  suspended or revoked to practice medicine.
  485         (c) Attempting to obtain or obtaining a license to practice
  486  medicine by knowing misrepresentation.
  487         (d) Attempting to obtain or obtaining a position as a
  488  medical practitioner or medical resident in a clinic or hospital
  489  through knowing misrepresentation of education, training, or
  490  experience.
  491         (e)Knowingly operating, owning, or managing a
  492  nonregistered pain-management clinic that is required to be
  493  registered with the Department of Health pursuant to s.
  494  458.3265(1).
  495         (2) Each of the following acts constitutes a misdemeanor of
  496  the first degree, punishable as provided in s. 775.082 or s.
  497  775.083:
  498         (a) Knowingly concealing information relating to violations
  499  of this chapter.
  500         (b) Making any willfully false oath or affirmation whenever
  501  an oath or affirmation is required by this chapter.
  502         (c) Referring any patient, for health care goods or
  503  services, to a partnership, firm, corporation, or other business
  504  entity in which the physician or the physician’s employer has an
  505  equity interest of 10 percent or more unless, prior to such
  506  referral, the physician notifies the patient of his or her
  507  financial interest and of the patient’s right to obtain such
  508  goods or services at the location of the patient’s choice. This
  509  section does not apply to the following types of equity
  510  interest:
  511         1. The ownership of registered securities issued by a
  512  publicly held corporation or the ownership of securities issued
  513  by a publicly held corporation, the shares of which are traded
  514  on a national exchange or the over-the-counter market;
  515         2. A physician’s own practice, whether he or she is a sole
  516  practitioner or part of a group, when the health care good or
  517  service is prescribed or provided solely for the physician’s own
  518  patients and is provided or performed by the physician or under
  519  the physician’s supervision; or
  520         3. An interest in real property resulting in a landlord
  521  tenant relationship between the physician and the entity in
  522  which the equity interest is held, unless the rent is
  523  determined, in whole or in part, by the business volume or
  524  profitability of the tenant or is otherwise unrelated to fair
  525  market value.
  526         (d) Leading the public to believe that one is licensed as a
  527  medical doctor, or is engaged in the licensed practice of
  528  medicine, without holding a valid, active license.
  529         (e) Practicing medicine or attempting to practice medicine
  530  with an inactive or delinquent license.
  531         (f) Knowingly prescribing or dispensing, or causing to be
  532  prescribed or dispensed, controlled substances in a
  533  nonregistered pain-management clinic that is required to be
  534  registered with the Department of Health pursuant to s.
  535  458.3265(1).
  536         Section 6. Paragraphs (oo), (pp), and (qq) are added to
  537  subsection (1) of section 458.331, Florida Statutes, to read:
  538         458.331 Grounds for disciplinary action; action by the
  539  board and department.—
  540         (1) The following acts constitute grounds for denial of a
  541  license or disciplinary action, as specified in s. 456.072(2):
  542         (oo) Applicable to a licensee who serves as the designated
  543  physician of a pain-management clinic as defined in s. 458.3265
  544  or s. 459.0137:
  545         1.Registering a pain-management clinic through
  546  misrepresentation or fraud;
  547         2.Procuring, or attempting to procure, the registration of
  548  a pain-management clinic for any other person by making or
  549  causing to be made, any false representation;
  550         3.Failing to comply with any requirement of chapter 499,
  551  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  552  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  553  the Drug Abuse Prevention and Control Act; or chapter 893, the
  554  Florida Comprehensive Drug Abuse Prevention and Control Act;
  555         4.Being convicted or found guilty of, regardless of
  556  adjudication to, a felony or any other crime involving moral
  557  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  558  the courts of this state, of any other state, or of the United
  559  States;
  560         5.Being convicted of, or disciplined by a regulatory
  561  agency of the Federal Government or a regulatory agency of
  562  another state for any offense that would constitute a violation
  563  of this chapter;
  564         6.Being convicted of, or entering a plea of guilty or nolo
  565  contendere to, regardless of adjudication, a crime in any
  566  jurisdiction of the courts of this state, of any other state, or
  567  of the United States which relates to the practice of, or the
  568  ability to practice, a licensed health care profession;
  569         7.Being convicted of, or entering a plea of guilty or nolo
  570  contendere to, regardless of adjudication, a crime in any
  571  jurisdiction of the courts of this state, of any other state, or
  572  of the United States which relates to health care fraud;
  573         8.Dispensing any medicinal drug based upon a communication
  574  that purports to be a prescription as defined in s. 465.003(14)
  575  or s. 893.02 if the dispensing practitioner knows or has reason
  576  to believe that the purported prescription is not based upon a
  577  valid practitioner-patient relationship; or
  578         9.Failing to timely notify the board of the date of his or
  579  her termination from a pain-management clinic as required by s.
  580  458.3265(2).
  581         (pp)Failing to timely notify the department of the theft
  582  of prescription blanks from a pain-management clinic or a breach
  583  of other methods for prescribing within 24 hours as required by
  584  s. 458.3265(2).
  585         (qq) Promoting or advertising through any communication
  586  media the use, sale, or dispensing of any controlled substance
  587  appearing on any schedule in chapter 893.
  588         Section 7. Subsections (3), (4), and (5) of section
  589  459.005, Florida Statutes, are repealed.
  590         Section 8. Section 459.0137, Florida Statutes, is created
  591  to read:
  592         459.0137Pain-management clinics.—
  593         (1)REGISTRATION.—
  594         (a) All privately owned pain-management clinics,
  595  facilities, or offices, hereinafter referred to as “clinics,”
  596  which advertise in any medium for any type of pain-management
  597  services, or employ an osteopathic physician who is primarily
  598  engaged in the treatment of pain by prescribing or dispensing
  599  controlled substance medications, must register with the
  600  department unless:
  601         1. That clinic is licensed as a facility pursuant to
  602  chapter 395;
  603         2. The majority of the physicians who provide services in
  604  the clinic primarily provide surgical services;
  605         3.The clinic is owned by a publicly held corporation whose
  606  shares are traded on a national exchange or on the over-the
  607  counter market and whose total assets at the end of the
  608  corporation’s most recent fiscal quarter exceeded $50 million;
  609         4.The clinic is affiliated with an accredited medical
  610  school at which training is provided for medical students,
  611  residents, or fellows;
  612         5. The clinic does not prescribe or dispense controlled
  613  substances for the treatment of pain; or
  614         6. The clinic is owned by a corporate entity exempt from
  615  federal taxation under 26 U.S.C. s. 501(c)(3).
  616         (b) Each clinic location shall be registered separately
  617  regardless of whether the clinic is operated under the same
  618  business name or management as another clinic.
  619         (c) As a part of registration, a clinic must designate an
  620  osteopathic physician who is responsible for complying with all
  621  requirements related to registration and operation of the clinic
  622  in compliance with this section. Within 10 days after
  623  termination of a designated osteopathic physician, the clinic
  624  must notify the department of the identity of another designated
  625  physician for that clinic. The designated physician shall have a
  626  full, active, and unencumbered license under chapter 458 or this
  627  chapter and shall practice at the clinic location for which the
  628  physician has assumed responsibility. Failing to have a licensed
  629  designated osteopathic physician practicing at the location of
  630  the registered clinic may be the basis for a summary suspension
  631  of the clinic registration certificate as described in s.
  632  456.073(8) for a license or s. 120.60(6).
  633         (d)The department shall deny registration to any clinic
  634  that is not fully owned by a physician licensed under chapter
  635  458 or this chapter or a group of physicians, each of whom is
  636  licensed under chapter 458 or this chapter; or that is not a
  637  health care clinic licensed under part X of chapter 400.
  638         (e) The department shall deny registration to any pain
  639  management clinic owned by or with any contractual or employment
  640  relationship with a physician:
  641         1. Whose Drug Enforcement Administration number has ever
  642  been revoked.
  643         2. Whose application for a license to prescribe, dispense,
  644  or administer a controlled substance has been denied by any
  645  jurisdiction.
  646         3. Who has been convicted of or plead guilty or nolo
  647  contendere to, regardless of adjudication, an offense that
  648  constitutes a felony for receipt of illicit and diverted drugs,
  649  including a controlled substance listed in Schedule I, Schedule
  650  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  651  this state, any other state, or the United States.
  652         (f) If the department finds that a pain-management clinic
  653  does not meet the requirement of paragraph (d) or is owned,
  654  directly or indirectly, by a person meeting any criteria listed
  655  in paragraph (e), the department shall revoke the certificate of
  656  registration previously issued by the department. As determined
  657  by rule, the department may grant an exemption to denying a
  658  registration or revoking a previously issued registration if
  659  more than 10 years have elapsed since adjudication. As used in
  660  this subsection, the term “convicted” includes an adjudication
  661  of guilt following a plea of guilty or nolo contendere or the
  662  forfeiture of a bond when charged with a crime.
  663         (g) The department may revoke the clinic’s certificate of
  664  registration and prohibit all physicians associated with that
  665  pain-management clinic from practicing at that clinic location
  666  based upon an annual inspection and evaluation of the factors
  667  described in subsection (3).
  668         (h)If the registration of a pain-management clinic is
  669  revoked or suspended, the designated physician of the pain
  670  management clinic, the owner or lessor of the pain-management
  671  clinic property, the manager, and the proprietor shall cease to
  672  operate the facility as a pain-management clinic as of the
  673  effective date of the suspension or revocation.
  674         (i)If a pain-management clinic registration is revoked or
  675  suspended, the designated physician of the pain-management
  676  clinic, the owner or lessor of the clinic property, the manager,
  677  or the proprietor is responsible for removing all signs and
  678  symbols identifying the premises as a pain-management clinic.
  679         (j)Upon the effective date of the suspension or
  680  revocation, the designated physician of the pain-management
  681  clinic shall advise the department of the disposition of the
  682  medicinal drugs located on the premises. The disposition is
  683  subject to the supervision and approval of the department.
  684  Medicinal drugs that are purchased or held by a pain–management
  685  clinic that is not registered may be deemed adulterated pursuant
  686  to s. 499.006.
  687         (k)If the clinic’s registration is revoked, any person
  688  named in the registration documents of the pain-management
  689  clinic, including persons owning or operating the pain
  690  management clinic, may not as an individual or as a part of a
  691  group, make application for a permit to operate a pain
  692  management clinic for 5 years after the date the registration is
  693  revoked.
  694         (l)The period of suspension for the registration of a pain
  695  management clinic shall be prescribed by the department, but may
  696  not exceed 1 year.
  697         (m) A change of ownership of a registered pain-management
  698  clinic requires submission of a new registration application.
  699         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  700  apply to any osteopathic physician who provides professional
  701  services in a pain-management clinic that is required to be
  702  registered in subsection (1).
  703         (a)An osteopathic physician may not practice medicine in a
  704  pain-management clinic, as described in subsection (4), if:
  705         1.The pain-management clinic is not registered with the
  706  department as required by this section; or
  707         2.Effective July 1, 2012, the physician has not
  708  successfully completed a pain medicine fellowship that is
  709  accredited by the Accreditation Council for Graduate Medical
  710  Education or the American Osteopathic Association or a pain
  711  medicine residency that is accredited by the Accreditation
  712  Council for Graduate Medical Education or the American
  713  Osteopathic Association or, prior to July 1, 2012, does not
  714  comply with rules adopted by the board.
  715  
  716  Any physician who qualifies to practice medicine in a pain
  717  management clinic pursuant to rules adopted by the Board of
  718  Osteopathic Medicine as of July 1, 2012, may continue to
  719  practice medicine in a pain-management clinic as long as the
  720  physician continues to meet the qualifications set forth in the
  721  board rules. An osteopathic physician who violates this
  722  paragraph is subject to disciplinary action by his or her
  723  appropriate medical regulatory board.
  724         (b)A person may not dispense any medication, including a
  725  controlled substance, on the premises of a registered pain
  726  management clinic unless he or she is a physician licensed under
  727  this chapter or chapter 458.
  728         (c)An osteopathic physician must perform a physical
  729  examination of a patient on the same day that he or she
  730  dispenses or prescribes a controlled substance to a patient at a
  731  pain-management clinic. If the osteopathic physician prescribes
  732  or dispenses more than a 72-hour dose of controlled substances
  733  for the treatment of chronic nonmalignant pain, the osteopathic
  734  physician must document in the patient’s record the reason for
  735  prescribing or dispensing that quantity.
  736         (d) An osteopathic physician authorized to prescribe
  737  controlled substances who practices at a pain-management clinic
  738  is responsible for maintaining the control and security of his
  739  or her prescription blanks and any other method used for
  740  prescribing controlled substance pain medication. The
  741  osteopathic physician shall comply with the requirements for
  742  counterfeit-resistant prescription blanks in s. 893.065 and the
  743  rules adopted pursuant to that section. The osteopathic
  744  physician shall notify in writing the department within 24 hours
  745  following any theft or loss of a prescription blank or breach of
  746  any other method for prescribing pain medication.
  747         (e)The designated osteopathic physician of a pain
  748  management clinic shall notify the applicable board in writing
  749  of the date of termination of employment within 10 days after
  750  terminating his or her employment with a pain-management clinic
  751  that is required to be registered under subsection (1).
  752         (3) INSPECTION.—
  753         (a) The department shall inspect the pain-management clinic
  754  annually, including a review of the patient records, to ensure
  755  that it complies with this section and the rules of the Board of
  756  Osteopathic Medicine adopted pursuant to subsection (4) unless
  757  the clinic is accredited by a nationally recognized accrediting
  758  agency approved by the Board of Osteopathic Medicine.
  759         (b) During an onsite inspection, the department shall make
  760  a reasonable attempt to discuss each violation with the owner or
  761  designated physician of the pain-management clinic before
  762  issuing a formal written notification.
  763         (c) Any action taken to correct a violation shall be
  764  documented in writing by the owner or designated physician of
  765  the pain-management clinic and verified by followup visits by
  766  departmental personnel.
  767         (4) RULEMAKING.—
  768         (a) The department shall adopt rules necessary to
  769  administer the registration and inspection of pain-management
  770  clinics which establish the specific requirements, procedures,
  771  forms, and fees.
  772         (b) The department shall adopt a rule defining what
  773  constitutes practice by a designated osteopathic physician at
  774  the clinic location for which the physician has assumed
  775  responsibility, as set forth in subsection (1). When adopting
  776  the rule, the department shall consider the number of clinic
  777  employees, the location of the pain-management clinic, the
  778  clinic’s hours of operation, and the amount of controlled
  779  substances being prescribed, dispensed, or administered at the
  780  pain-management clinic.
  781         (c) The Board of Osteopathic Medicine shall adopt a rule
  782  establishing the maximum number of prescriptions for Schedule II
  783  or Schedule III controlled substances or the controlled
  784  substance Alprazolam which may be written at any one registered
  785  pain-management clinic during any 24-hour period.
  786         (d)The Board of Osteopathic Medicine shall adopt rules
  787  setting forth standards of practice for osteopathic physicians
  788  practicing in privately owned pain-management clinics that
  789  primarily engage in the treatment of pain by prescribing or
  790  dispensing controlled substance medications. Such rules shall
  791  address, but need not be limited to:
  792         1.Facility operations;
  793         2.Physical operations;
  794         3.Infection control requirements;
  795         4.Health and safety requirements;
  796         5.Quality assurance requirements;
  797         6.Patient records;
  798         7.Training requirements for all facility health care
  799  practitioners who are not regulated by another board;
  800         8.Inspections; and
  801         9.Data collection and reporting requirements.
  802  
  803  An osteopathic physician is primarily engaged in the treatment
  804  of pain by prescribing or dispensing controlled substance
  805  medications when the majority of the patients seen are
  806  prescribed or dispensed controlled substance medications for the
  807  treatment of chronic nonmalignant pain. Chronic nonmalignant
  808  pain is pain unrelated to cancer which persists beyond the usual
  809  course of the disease or the injury that is the cause of the
  810  pain or more than 90 days after surgery.
  811         (5) PENALTIES; ENFORCEMENT.—
  812         (a)The department may impose an administrative fine on the
  813  clinic of up to $5,000 per violation for violating the
  814  requirements of this section; chapter 499, the Florida Drug and
  815  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  816  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  817  Abuse Prevention and Control Act; chapter 893, the Florida
  818  Comprehensive Drug Abuse Prevention and Control Act; or the
  819  rules of the department. In determining whether a penalty is to
  820  be imposed, and in fixing the amount of the fine, the department
  821  shall consider the following factors:
  822         1. The gravity of the violation, including the probability
  823  that death or serious physical or emotional harm to a patient
  824  has resulted, or could have resulted, from the pain-management
  825  clinic’s actions or the actions of the osteopathic physician,
  826  the severity of the action or potential harm, and the extent to
  827  which the provisions of the applicable laws or rules were
  828  violated.
  829         2. What actions, if any, the owner or designated
  830  osteopathic physician took to correct the violations.
  831         3. Whether there were any previous violations at the pain
  832  management clinic.
  833         4. The financial benefits that the pain-management clinic
  834  derived from committing or continuing to commit the violation.
  835         (b) Each day a violation continues after the date fixed for
  836  termination of the violation as ordered by the department
  837  constitutes an additional, separate, and distinct violation.
  838         (c) The department may impose a fine and, in the case of an
  839  owner-operated pain-management clinic, revoke or deny a pain
  840  management clinic’s registration, if the clinic’s designated
  841  osteopathic physician knowingly and intentionally misrepresents
  842  actions taken to correct a violation.
  843         (d) An owner or designated osteopathic physician of a pain
  844  management clinic who concurrently operates an unregistered
  845  pain-management clinic is subject to an administrative fine of
  846  $5,000 per day.
  847         (e) If the owner of a pain-management clinic that requires
  848  registration fails to apply to register the clinic upon a
  849  change-of-ownership and operates the clinic under the new
  850  ownership, the owner is subject to a fine of $5,000.
  851         Section 9. Subsections (1) and (2) of section 459.013,
  852  Florida Statutes, are amended to read:
  853         459.013 Penalty for violations.—
  854         (1) Each of the following acts constitutes a felony of the
  855  third degree, punishable as provided in s. 775.082, s. 775.083,
  856  or s. 775.084:
  857         (a) The practice of osteopathic medicine, or an attempt to
  858  practice osteopathic medicine, without an active license or
  859  certificate issued pursuant to this chapter.
  860         (b) The practice of osteopathic medicine by a person
  861  holding a limited license, osteopathic faculty certificate, or
  862  other certificate issued under this chapter beyond the scope of
  863  practice authorized for such licensee or certificateholder.
  864         (c) Attempting to obtain or obtaining a license to practice
  865  osteopathic medicine by knowing misrepresentation.
  866         (d) Attempting to obtain or obtaining a position as an
  867  osteopathic medical practitioner or osteopathic medical resident
  868  in a clinic or hospital through knowing misrepresentation of
  869  education, training, or experience.
  870         (e)Knowingly operating, owning, or managing a
  871  nonregistered pain-management clinic that is required to be
  872  registered with the Department of Health pursuant to s.
  873  459.0137(1).
  874         (2) Each of the following acts constitutes a misdemeanor of
  875  the first degree, punishable as provided in s. 775.082 or s.
  876  775.083:
  877         (a) Knowingly concealing information relating to violations
  878  of this chapter.
  879         (b) Making any willfully false oath or affirmation whenever
  880  an oath or affirmation is required by this chapter.
  881         (c) The practice of medicine as a resident or intern
  882  without holding a valid current registration pursuant to s.
  883  459.021.
  884         (d) Knowingly prescribing or dispensing, or causing to be
  885  prescribed or dispensed, controlled substances in a
  886  nonregistered pain-management clinic that is required to be
  887  registered with the Department of Health pursuant to s.
  888  459.0137(1).
  889         Section 10. Paragraphs (qq), (rr), and (ss) are added to
  890  subsection (1) of section 459.015, Florida Statutes, to read:
  891         459.015 Grounds for disciplinary action; action by the
  892  board and department.—
  893         (1) The following acts constitute grounds for denial of a
  894  license or disciplinary action, as specified in s. 456.072(2):
  895         (qq) Applicable to a licensee who serves as the designated
  896  physician of a pain-management clinic as defined in s. 458.3265
  897  or s. 459.0137:
  898         1.Registering a pain-management clinic through
  899  misrepresentation or fraud;
  900         2.Procuring, or attempting to procure, the registration of
  901  a pain-management clinic for any other person by making or
  902  causing to be made, any false representation;
  903         3.Failing to comply with any requirement of chapter 499,
  904  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  905  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  906  the Drug Abuse Prevention and Control Act; or chapter 893, the
  907  Florida Comprehensive Drug Abuse Prevention and Control Act;
  908         4.Being convicted or found guilty of, regardless of
  909  adjudication to, a felony or any other crime involving moral
  910  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  911  the courts of this state, of any other state, or of the United
  912  States;
  913         5.Being convicted of, or disciplined by a regulatory
  914  agency of the Federal Government or a regulatory agency of
  915  another state for any offense that would constitute a violation
  916  of this chapter;
  917         6.Being convicted of, or entering a plea of guilty or nolo
  918  contendere to, regardless of adjudication, a crime in any
  919  jurisdiction of the courts of this state, of any other state, or
  920  of the United States which relates to the practice of, or the
  921  ability to practice, a licensed health care profession;
  922         7.Being convicted of, or entering a plea of guilty or nolo
  923  contendere to, regardless of adjudication, a crime in any
  924  jurisdiction of the courts of this state, of any other state, or
  925  of the United States which relates to health care fraud;
  926         8.Dispensing any medicinal drug based upon a communication
  927  that purports to be a prescription as defined in s. 465.003(14)
  928  or s. 893.02 if the dispensing practitioner knows or has reason
  929  to believe that the purported prescription is not based upon a
  930  valid practitioner-patient relationship; or
  931         9.Failing to timely notify the board of the date of his or
  932  her termination from a pain-management clinic as required by s.
  933  459.0137(2).
  934         (rr)Failing to timely notify the department of the theft
  935  of prescription blanks from a pain-management clinic or a breach
  936  of other methods for prescribing within 24 hours as required by
  937  s. 459.0137(2).
  938         (ss) Promoting or advertising through any communication
  939  media the use, sale, or dispensing of any controlled substance
  940  appearing on any schedule in chapter 893.
  941         Section 11. Subsection (1) of section 465.0276, Florida
  942  Statutes, is amended to read:
  943         465.0276 Dispensing practitioner.—
  944         (1)(a) A person may not dispense medicinal drugs unless
  945  licensed as a pharmacist or otherwise authorized under this
  946  chapter to do so, except that a practitioner authorized by law
  947  to prescribe drugs may dispense such drugs to her or his
  948  patients in the regular course of her or his practice in
  949  compliance with this section.
  950         (b) A practitioner registered under this section may not
  951  dispense more than a 72-hour supply of a controlled substance
  952  listed in Schedule II, Schedule III, Schedule IV, or Schedule V
  953  of s. 893.03 for any patient who pays for the medication by
  954  cash, check, or credit card in a clinic registered under s.
  955  458.3265 or s. 459.0137. A practitioner who violates this
  956  paragraph commits a felony of the third degree, punishable as
  957  provided in s. 775.082, s. 775.083, or s. 775.084. This
  958  paragraph does not apply to:
  959         1. A practitioner who dispenses medication to a workers’
  960  compensation patient pursuant to chapter 440.
  961         2. A practitioner who dispenses medication to an insured
  962  patient who pays by cash, check, or credit card to cover any
  963  applicable copayment or deductible.
  964         3. The dispensing of complimentary packages of medicinal
  965  drugs to the practitioner’s own patients in the regular course
  966  of her or his practice without the payment of a fee or
  967  remuneration of any kind, whether direct or indirect, as
  968  provided in subsection (5).
  969         Section 12. Paragraph (j) is added to subsection (1),
  970  paragraph (d) is added to subsection (2), and paragraph (f) is
  971  added to subsection (7) of section 893.055, Florida Statutes, to
  972  read:
  973         893.055 Prescription drug monitoring program.—
  974         (1) As used in this section, the term:
  975         (j) “Program manager” means an employee of or a person
  976  contracted by the Department of Health who is designated to
  977  ensure the integrity of the prescription drug monitoring program
  978  in accordance with the requirements established in paragraphs
  979  (2)(a) and (b).
  980         (2)
  981         (d) The program manager shall work with professional health
  982  care licensure boards and the stakeholders listed in paragraph
  983  (b) to develop rules appropriate for identifying indicators of
  984  controlled substance abuse.
  985         (7)
  986         (f) The program manager, upon determining a pattern
  987  consistent with the rules established under paragraph (2)(c) and
  988  having cause to believe a violation of s. 893.13(7)(a)8.,
  989  (8)(a), or (8)(b) has occurred, may provide relevant information
  990  to the applicable law enforcement agency.
  991         Section 13. Subsections (4), (5), and (6) of section
  992  893.0551, Florida Statutes, are renumbered as subsections (5),
  993  (6), and (7), respectively, and subsection (4) is added to that
  994  section, to read:
  995         893.0551 Public records exemption for the prescription drug
  996  monitoring program.—
  997         (4) The department shall disclose such confidential and
  998  exempt information to the applicable law enforcement agency in
  999  accordance with s. 893.055(7)(b)2. The law enforcement agency
 1000  may disclose the confidential and exempt information received
 1001  from the department to a criminal justice agency as defined in
 1002  s. 119.011 as part of an active investigation that is specific
 1003  to a violation of s. 893.13(7)(a)8., s. 893.13(8)(a), or s.
 1004  893.13(8)(b).
 1005         Section 14. This act shall take effect October 1, 2010.

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