August 20, 2019
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       Florida Senate - 2010     CS for CS for SB 2272 & CS for SB 2722
       
       
       
       By the Committees on Criminal Justice; Health Regulation; and
       Health Regulation; and Senators Fasano, Gardiner, Aronberg,
       Gaetz, and Gelber
       
       
       591-04798-10                                          20102272c2
    1                        A bill to be entitled                      
    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. 893.055, F.S.;
  124         providing for the prescription drug monitoring
  125         program’s database to report certain information
  126         directly to applicable law enforcement agencies for
  127         investigation; requiring the department to adopt
  128         rules; amending s. 893.0551, F.S.; providing for
  129         disclosure of confidential and exempt information to
  130         applicable law enforcement; providing an effective
  131         date.
  132  
  133  Be It Enacted by the Legislature of the State of Florida:
  134  
  135         Section 1. Subsection (5) of section 456.037, Florida
  136  Statutes, is amended to read:
  137         456.037 Business establishments; requirements for active
  138  status licenses; delinquency; discipline; applicability.—
  139         (5) This section applies to any business establishment
  140  registered, permitted, or licensed by the department to do
  141  business. Business establishments include, but are not limited
  142  to, dental laboratories, electrology facilities, massage
  143  establishments, and pharmacies, and pain-management clinics
  144  required to be registered under s. 458.3265 or s. 459.0137.
  145         Section 2. Paragraph (a) of subsection (9) of section
  146  456.057, Florida Statutes, is amended to read:
  147         456.057 Ownership and control of patient records; report or
  148  copies of records to be furnished.—
  149         (9)(a)1. The department may obtain patient records pursuant
  150  to a subpoena without written authorization from the patient if
  151  the department and the probable cause panel of the appropriate
  152  board, if any, find reasonable cause to believe that a health
  153  care practitioner has excessively or inappropriately prescribed
  154  any controlled substance specified in chapter 893 in violation
  155  of this chapter or any professional practice act or that a
  156  health care practitioner has practiced his or her profession
  157  below that level of care, skill, and treatment required as
  158  defined by this chapter or any professional practice act and
  159  also find that appropriate, reasonable attempts were made to
  160  obtain a patient release. Notwithstanding the foregoing, the
  161  department need not attempt to obtain a patient release when
  162  investigating an offense involving the inappropriate
  163  prescribing, overprescribing, or diversion of controlled
  164  substances and the offense involves a pain-management clinic.
  165  The department may obtain patient records without patient
  166  authorization or subpoena from any pain-management clinic
  167  required to be licensed if the department has probable cause to
  168  believe that a violation of any provision of s. 458.3265 or s.
  169  459.0137 is occurring or has occurred and reasonably believes
  170  that obtaining such authorization is not feasible due to the
  171  volume of the dispensing and prescribing activity involving
  172  controlled substances and that obtaining patient authorization
  173  or the issuance of a subpoena would jeopardize the
  174  investigation.
  175         2. The department may obtain patient records and insurance
  176  information pursuant to a subpoena without written authorization
  177  from the patient if the department and the probable cause panel
  178  of the appropriate board, if any, find reasonable cause to
  179  believe that a health care practitioner has provided inadequate
  180  medical care based on termination of insurance and also find
  181  that appropriate, reasonable attempts were made to obtain a
  182  patient release.
  183         3. The department may obtain patient records, billing
  184  records, insurance information, provider contracts, and all
  185  attachments thereto pursuant to a subpoena without written
  186  authorization from the patient if the department and probable
  187  cause panel of the appropriate board, if any, find reasonable
  188  cause to believe that a health care practitioner has submitted a
  189  claim, statement, or bill using a billing code that would result
  190  in payment greater in amount than would be paid using a billing
  191  code that accurately describes the services performed, requested
  192  payment for services that were not performed by that health care
  193  practitioner, used information derived from a written report of
  194  an automobile accident generated pursuant to chapter 316 to
  195  solicit or obtain patients personally or through an agent
  196  regardless of whether the information is derived directly from
  197  the report or a summary of that report or from another person,
  198  solicited patients fraudulently, received a kickback as defined
  199  in s. 456.054, violated the patient brokering provisions of s.
  200  817.505, or presented or caused to be presented a false or
  201  fraudulent insurance claim within the meaning of s.
  202  817.234(1)(a), and also find that, within the meaning of s.
  203  817.234(1)(a), patient authorization cannot be obtained because
  204  the patient cannot be located or is deceased, incapacitated, or
  205  suspected of being a participant in the fraud or scheme, and if
  206  the subpoena is issued for specific and relevant records.
  207         4. Notwithstanding subparagraphs 1.-3., when the department
  208  investigates a professional liability claim or undertakes action
  209  pursuant to s. 456.049 or s. 627.912, the department may obtain
  210  patient records pursuant to a subpoena without written
  211  authorization from the patient if the patient refuses to
  212  cooperate or if the department attempts to obtain a patient
  213  release and the failure to obtain the patient records would be
  214  detrimental to the investigation.
  215         Section 3. Subsections (4), (5), and (6) of section
  216  458.309, Florida Statutes, are repealed.
  217         Section 4. Section 458.3265, Florida Statutes, is created
  218  to read:
  219         458.3265Pain-management clinics.—
  220         (1)REGISTRATION.—
  221         (a) All privately owned pain-management clinics,
  222  facilities, or offices, hereinafter referred to as “clinics,”
  223  which advertise in any medium for any type of pain-management
  224  services, or employ a physician who is primarily engaged in the
  225  treatment of pain by prescribing or dispensing controlled
  226  substance medications, must register with the department unless:
  227         1. That clinic is licensed as a facility pursuant to
  228  chapter 395;
  229         2. The majority of the physicians who provide services in
  230  the clinic primarily provide surgical services;
  231         3. The physicians who provide services in the clinic
  232  primarily provide chiropractic services and do not dispense
  233  controlled substances.
  234         4. The clinic is owned by a publicly held corporation whose
  235  shares are traded on a national exchange or on the over-the
  236  counter market and whose total assets at the end of the
  237  corporation’s most recent fiscal quarter exceeded $50 million;
  238         5. The clinic is affiliated with an accredited medical
  239  school at which training is provided for medical students,
  240  residents, or fellows;
  241         6. The clinic does not prescribe or dispense controlled
  242  substances for the treatment of pain; or
  243         7. The clinic is owned by a corporate entity exempt from
  244  federal taxation under 26 U.S.C. s. 501(c)(3).
  245         (b) Each clinic location shall be registered separately
  246  regardless of whether the clinic is operated under the same
  247  business name or management as another clinic.
  248         (c) As a part of registration, a clinic must designate a
  249  physician who is responsible for complying with all requirements
  250  related to registration and operation of the clinic in
  251  compliance with this section. Within 10 days after termination
  252  of a designated physician, the clinic must notify the department
  253  of the identity of another designated physician for that clinic.
  254  The designated physician shall have a full, active, and
  255  unencumbered license under this chapter or chapter 459 and shall
  256  practice at the clinic location for which the physician has
  257  assumed responsibility. Failing to have a licensed designated
  258  physician practicing at the location of the registered clinic
  259  may be the basis for a summary suspension of the clinic
  260  registration certificate as described in s. 456.073(8) for a
  261  license or s. 120.60(6).
  262         (d)The department shall deny registration to any clinic
  263  that is not fully owned by a physician licensed under this
  264  chapter or chapter 459 or a group of physicians, each of whom is
  265  licensed under this chapter or chapter 459; or that is not a
  266  health care clinic licensed under part X of chapter 400.
  267         (e) The department shall deny registration to any pain
  268  management clinic owned by or with any contractual or employment
  269  relationship with a physician:
  270         1. Whose Drug Enforcement Administration number has ever
  271  been revoked.
  272         2. Whose application for a license to prescribe, dispense,
  273  or administer a controlled substance has been denied by any
  274  jurisdiction.
  275         3. Who has been convicted of or plead guilty or nolo
  276  contendere to, regardless of adjudication, an offense that
  277  constitutes a felony for receipt of illicit and diverted drugs,
  278  including a controlled substance listed in Schedule I, Schedule
  279  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  280  this state, any other state, or the United States.
  281         (f) If the department finds that a pain-management clinic
  282  does not meet the requirement of paragraph (d) or is owned,
  283  directly or indirectly, by a person meeting any criteria listed
  284  in paragraph (e), the department shall revoke the certificate of
  285  registration previously issued by the department. As determined
  286  by rule, the department may grant an exemption to denying a
  287  registration or revoking a previously issued registration if
  288  more than 10 years have elapsed since adjudication. As used in
  289  this subsection, the term “convicted” includes an adjudication
  290  of guilt following a plea of guilty or nolo contendere or the
  291  forfeiture of a bond when charged with a crime.
  292         (g) The department may revoke the clinic’s certificate of
  293  registration and prohibit all physicians associated with that
  294  pain-management clinic from practicing at that clinic location
  295  based upon an annual inspection and evaluation of the factors
  296  described in subsection (3).
  297         (h)If the registration of a pain-management clinic is
  298  revoked or suspended, the designated physician of the pain
  299  management clinic, the owner or lessor of the pain-management
  300  clinic property, the manager, and the proprietor shall cease to
  301  operate the facility as a pain-management clinic as of the
  302  effective date of the suspension or revocation.
  303         (i)If a pain-management clinic registration is revoked or
  304  suspended, the designated physician of the pain-management
  305  clinic, the owner or lessor of the clinic property, the manager,
  306  or the proprietor is responsible for removing all signs and
  307  symbols identifying the premises as a pain-management clinic.
  308         (j)Upon the effective date of the suspension or
  309  revocation, the designated physician of the pain-management
  310  clinic shall advise the department of the disposition of the
  311  medicinal drugs located on the premises. The disposition is
  312  subject to the supervision and approval of the department.
  313  Medicinal drugs that are purchased or held by a pain–management
  314  clinic that is not registered may be deemed adulterated pursuant
  315  to s. 499.006.
  316         (k)If the clinic’s registration is revoked, any person
  317  named in the registration documents of the pain-management
  318  clinic, including persons owning or operating the pain
  319  management clinic, may not, as an individual or as a part of a
  320  group, apply to operate a pain-management clinic for 5 years
  321  after the date the registration is revoked.
  322         (l)The period of suspension for the registration of a pain
  323  management clinic shall be prescribed by the department, but may
  324  not exceed 1 year.
  325         (m) A change of ownership of a registered pain-management
  326  clinic requires submission of a new registration application.
  327         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  328  apply to any physician who provides professional services in a
  329  pain-management clinic that is required to be registered in
  330  subsection (1).
  331         (a)A physician may not practice medicine in a pain
  332  management clinic, as described in subsection (4), if:
  333         1.The pain-management clinic is not registered with the
  334  department as required by this section; or
  335         2.Effective July 1, 2012, the physician has not
  336  successfully completed a pain medicine fellowship that is
  337  accredited by the Accreditation Council for Graduate Medical
  338  Education or a pain medicine residency that is accredited by the
  339  Accreditation Council for Graduate Medical Education or does not
  340  comply with rules adopted by the Board of Medicine.
  341  
  342  A physician who violates this paragraph is subject to
  343  disciplinary action by his or her appropriate medical regulatory
  344  board.
  345         (b)A person may not dispense any medication, including a
  346  controlled substance, on the premises of a registered pain
  347  management clinic unless he or she is a physician licensed under
  348  this chapter or chapter 459.
  349         (c)A physician must perform a physical examination of a
  350  patient on the same day that he or she dispenses or prescribes a
  351  controlled substance to a patient at a pain-management clinic.
  352  If the physician prescribes or dispenses more than a 72-hour
  353  dose of controlled substances for the treatment of chronic
  354  nonmalignant pain, the physician must document in the patient’s
  355  record the reason for prescribing or dispensing that quantity.
  356         (d) A physician authorized to prescribe controlled
  357  substances who practices at a pain-management clinic is
  358  responsible for maintaining the control and security of his or
  359  her prescription blanks and any other method used for
  360  prescribing controlled substance pain medication. The physician
  361  shall comply with the requirements for counterfeit-resistant
  362  prescription blanks in s. 893.065 and the rules adopted pursuant
  363  to that section. The physician shall notify in writing the
  364  department within 24 hours following any theft or loss of a
  365  prescription blank or breach of any other method for prescribing
  366  pain medication.
  367         (e)The designated physician of a pain-management clinic
  368  shall notify the applicable board in writing of the date of
  369  termination of employment within 10 days after terminating his
  370  or her employment with a pain-management clinic that is required
  371  to be registered under subsection (1).
  372         (3) INSPECTION.—
  373         (a) The department shall inspect the pain-management clinic
  374  annually, including a review of the patient records, to ensure
  375  that it complies with this section and the rules of the Board of
  376  Medicine adopted pursuant to subsection (4) unless the clinic is
  377  accredited by a nationally recognized accrediting agency
  378  approved by the Board of Medicine.
  379         (b) During an onsite inspection, the department shall make
  380  a reasonable attempt to discuss each violation with the owner or
  381  designated physician of the pain-management clinic before
  382  issuing a formal written notification.
  383         (c) Any action taken to correct a violation shall be
  384  documented in writing by the owner or designated physician of
  385  the pain-management clinic and verified by followup visits by
  386  departmental personnel.
  387         (4) RULEMAKING.—
  388         (a) The department shall adopt rules necessary to
  389  administer the registration and inspection of pain-management
  390  clinics which establish the specific requirements, procedures,
  391  forms, and fees.
  392         (b) The department shall adopt a rule defining what
  393  constitutes practice by a designated physician at the clinic
  394  location for which the physician has assumed responsibility, as
  395  set forth in subsection (1). When adopting the rule, the
  396  department shall consider the number of clinic employees, the
  397  location of the pain-management clinic, the clinic’s hours of
  398  operation, and the amount of controlled substances being
  399  prescribed, dispensed, or administered at the pain-management
  400  clinic.
  401         (c) The Board of Medicine shall adopt a rule establishing
  402  the maximum number of prescriptions for Schedule II or Schedule
  403  III controlled substances or the controlled substance Alprazolam
  404  which may be written at any one registered pain-management
  405  clinic during any 24-hour period.
  406         (d)The Board of Medicine shall adopt rules setting forth
  407  standards of practice for physicians practicing in privately
  408  owned pain-management clinics that primarily engage in the
  409  treatment of pain by prescribing or dispensing controlled
  410  substance medications. Such rules shall address, but need not be
  411  limited to:
  412         1.Facility operations;
  413         2.Physical operations;
  414         3.Infection control requirements;
  415         4.Health and safety requirements;
  416         5.Quality assurance requirements;
  417         6.Patient records;
  418         7.Training requirements for all facility health care
  419  practitioners who are not regulated by another board;
  420         8.Inspections; and
  421         9.Data collection and reporting requirements.
  422  
  423  A physician is primarily engaged in the treatment of pain by
  424  prescribing or dispensing controlled substance medications when
  425  the majority of the patients seen are prescribed or dispensed
  426  controlled substance medications for the treatment of chronic
  427  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  428  to cancer which persists beyond the usual course of the disease
  429  or the injury that is the cause of the pain or more than 90 days
  430  after surgery.
  431         (5) PENALTIES; ENFORCEMENT.—
  432         (a)The department may impose an administrative fine on the
  433  clinic of up to $5,000 per violation for violating the
  434  requirements of this section; chapter 499, the Florida Drug and
  435  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  436  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  437  Abuse Prevention and Control Act; chapter 893, the Florida
  438  Comprehensive Drug Abuse Prevention and Control Act; or the
  439  rules of the department. In determining whether a penalty is to
  440  be imposed, and in fixing the amount of the fine, the department
  441  shall consider the following factors:
  442         1. The gravity of the violation, including the probability
  443  that death or serious physical or emotional harm to a patient
  444  has resulted, or could have resulted, from the pain-management
  445  clinic’s actions or the actions of the physician, the severity
  446  of the action or potential harm, and the extent to which the
  447  provisions of the applicable laws or rules were violated.
  448         2. What actions, if any, the owner or designated physician
  449  took to correct the violations.
  450         3. Whether there were any previous violations at the pain
  451  management clinic.
  452         4. The financial benefits that the pain-management clinic
  453  derived from committing or continuing to commit the violation.
  454         (b) Each day a violation continues after the date fixed for
  455  termination of the violation as ordered by the department
  456  constitutes an additional, separate, and distinct violation.
  457         (c) The department may impose a fine and, in the case of an
  458  owner-operated pain-management clinic, revoke or deny a pain
  459  management clinic’s registration, if the clinic’s designated
  460  physician knowingly and intentionally misrepresents actions
  461  taken to correct a violation.
  462         (d) An owner or designated physician of a pain-management
  463  clinic who concurrently operates an unregistered pain-management
  464  clinic is subject to an administrative fine of $5,000 per day.
  465         (e) If the owner of a pain-management clinic that requires
  466  registration fails to apply to register the clinic upon a
  467  change-of-ownership and operates the clinic under the new
  468  ownership, the owner is subject to a fine of $5,000.
  469         Section 5. Section 458.327, Florida Statutes, is amended to
  470  read:
  471         458.327 Penalty for violations.—
  472         (1) Each of the following acts constitutes a felony of the
  473  third degree, punishable as provided in s. 775.082, s. 775.083,
  474  or s. 775.084:
  475         (a) The practice of medicine or an attempt to practice
  476  medicine without a license to practice in Florida.
  477         (b) The use or attempted use of a license which is
  478  suspended or revoked to practice medicine.
  479         (c) Attempting to obtain or obtaining a license to practice
  480  medicine by knowing misrepresentation.
  481         (d) Attempting to obtain or obtaining a position as a
  482  medical practitioner or medical resident in a clinic or hospital
  483  through knowing misrepresentation of education, training, or
  484  experience.
  485         (e)Knowingly operating, owning, or managing a
  486  nonregistered pain-management clinic that is required to be
  487  registered with the Department of Health pursuant to s.
  488  458.3265(1).
  489         (2) Each of the following acts constitutes a misdemeanor of
  490  the first degree, punishable as provided in s. 775.082 or s.
  491  775.083:
  492         (a) Knowingly concealing information relating to violations
  493  of this chapter.
  494         (b) Making any willfully false oath or affirmation whenever
  495  an oath or affirmation is required by this chapter.
  496         (c) Referring any patient, for health care goods or
  497  services, to a partnership, firm, corporation, or other business
  498  entity in which the physician or the physician’s employer has an
  499  equity interest of 10 percent or more unless, prior to such
  500  referral, the physician notifies the patient of his or her
  501  financial interest and of the patient’s right to obtain such
  502  goods or services at the location of the patient’s choice. This
  503  section does not apply to the following types of equity
  504  interest:
  505         1. The ownership of registered securities issued by a
  506  publicly held corporation or the ownership of securities issued
  507  by a publicly held corporation, the shares of which are traded
  508  on a national exchange or the over-the-counter market;
  509         2. A physician’s own practice, whether he or she is a sole
  510  practitioner or part of a group, when the health care good or
  511  service is prescribed or provided solely for the physician’s own
  512  patients and is provided or performed by the physician or under
  513  the physician’s supervision; or
  514         3. An interest in real property resulting in a landlord
  515  tenant relationship between the physician and the entity in
  516  which the equity interest is held, unless the rent is
  517  determined, in whole or in part, by the business volume or
  518  profitability of the tenant or is otherwise unrelated to fair
  519  market value.
  520         (d) Leading the public to believe that one is licensed as a
  521  medical doctor, or is engaged in the licensed practice of
  522  medicine, without holding a valid, active license.
  523         (e) Practicing medicine or attempting to practice medicine
  524  with an inactive or delinquent license.
  525         (f) Knowingly prescribing or dispensing, or causing to be
  526  prescribed or dispensed, controlled substances in a
  527  nonregistered pain-management clinic that is required to be
  528  registered with the Department of Health pursuant to s.
  529  458.3265(1).
  530         Section 6. Paragraphs (oo) and (pp) are added to subsection
  531  (1) of section 458.331, Florida Statutes, to read:
  532         458.331 Grounds for disciplinary action; action by the
  533  board and department.—
  534         (1) The following acts constitute grounds for denial of a
  535  license or disciplinary action, as specified in s. 456.072(2):
  536         (oo) Applicable to a licensee who serves as the designated
  537  physician of a pain-management clinic as defined in s. 458.3265
  538  or s. 459.0137:
  539         1.Registering a pain-management clinic through
  540  misrepresentation or fraud;
  541         2.Procuring, or attempting to procure, the registration of
  542  a pain-management clinic for any other person by making or
  543  causing to be made, any false representation;
  544         3.Failing to comply with any requirement of chapter 499,
  545  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  546  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  547  the Drug Abuse Prevention and Control Act; or chapter 893, the
  548  Florida Comprehensive Drug Abuse Prevention and Control Act;
  549         4.Being convicted or found guilty of, regardless of
  550  adjudication to, a felony or any other crime involving moral
  551  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  552  the courts of this state, of any other state, or of the United
  553  States;
  554         5.Being convicted of, or disciplined by a regulatory
  555  agency of the Federal Government or a regulatory agency of
  556  another state for any offense that would constitute a violation
  557  of this chapter;
  558         6.Being convicted of, or entering a plea of guilty or nolo
  559  contendere to, regardless of adjudication, a crime in any
  560  jurisdiction of the courts of this state, of any other state, or
  561  of the United States which relates to the practice of, or the
  562  ability to practice, a licensed health care profession;
  563         7.Being convicted of, or entering a plea of guilty or nolo
  564  contendere to, regardless of adjudication, a crime in any
  565  jurisdiction of the courts of this state, of any other state, or
  566  of the United States which relates to health care fraud;
  567         8.Dispensing any medicinal drug based upon a communication
  568  that purports to be a prescription as defined in s. 465.003(14)
  569  or s. 893.02 if the dispensing practitioner knows or has reason
  570  to believe that the purported prescription is not based upon a
  571  valid practitioner-patient relationship; or
  572         9.Failing to timely notify the board of the date of his or
  573  her termination from a pain-management clinic as required by s.
  574  458.3265(2).
  575         (pp)Failing to timely notify the department of the theft
  576  of prescription blanks from a pain-management clinic or a breach
  577  of other methods for prescribing within 24 hours as required by
  578  s. 458.3265(2).
  579         Section 7. Subsections (3), (4), and (5) of section
  580  459.005, Florida Statutes, are repealed.
  581         Section 8. Section 459.0137, Florida Statutes, is created
  582  to read:
  583         459.0137Pain-management clinics.—
  584         (1)REGISTRATION.—
  585         (a) All privately owned pain-management clinics,
  586  facilities, or offices, hereinafter referred to as “clinics,”
  587  which advertise in any medium for any type of pain-management
  588  services, or employ an osteopathic physician who is primarily
  589  engaged in the treatment of pain by prescribing or dispensing
  590  controlled substance medications, must register with the
  591  department unless:
  592         1. That clinic is licensed as a facility pursuant to
  593  chapter 395;
  594         2. The majority of the physicians who provide services in
  595  the clinic primarily provide surgical services;
  596         3. The physicians who provide services in the clinic
  597  primarily provide chiropractic services and do not dispense
  598  controlled substances.
  599         4. The clinic is owned by a publicly held corporation whose
  600  shares are traded on a national exchange or on the over-the
  601  counter market and whose total assets at the end of
  602  corporation’s most recent fiscal quarter exceeded $50 million;
  603         5. The clinic is affiliated with an accredited medical
  604  school at which training is provided for medical students,
  605  residents, or fellows;
  606         6. The clinic does not prescribe or dispense controlled
  607  substances for the treatment of pain; or
  608         7. The clinic is owned by a corporate entity exempt from
  609  federal taxation under 26 U.S.C. s. 501(c)(3).
  610         (b) Each clinic location shall be registered separately
  611  regardless of whether the clinic is operated under the same
  612  business name or management as another clinic.
  613         (c) As a part of registration, a clinic must designate an
  614  osteopathic physician who is responsible for complying with all
  615  requirements related to registration and operation of the clinic
  616  in compliance with this section. Within 10 days after
  617  termination of a designated osteopathic physician, the clinic
  618  must notify the department of the identity of another designated
  619  physician for that clinic. The designated physician shall have a
  620  full, active, and unencumbered license under chapter 458 or this
  621  chapter and shall practice at the clinic location for which the
  622  physician has assumed responsibility. Failing to have a licensed
  623  designated osteopathic physician practicing at the location of
  624  the registered clinic may be the basis for a summary suspension
  625  of the clinic registration certificate as described in s.
  626  456.073(8) for a license or s. 120.60(6).
  627         (d)The department shall deny registration to any clinic
  628  that is not fully owned by a physician licensed under chapter
  629  458 or this chapter or a group of physicians, each of whom is
  630  licensed under chapter 458 or this chapter; or that is not a
  631  health care clinic licensed under part X of chapter 400.
  632         (e) The department shall deny registration to any pain
  633  management clinic owned by or with any contractual or employment
  634  relationship with a physician:
  635         1. Whose Drug Enforcement Administration number has ever
  636  been revoked.
  637         2. Whose application for a license to prescribe, dispense,
  638  or administer a controlled substance has been denied by any
  639  jurisdiction.
  640         3. Who has been convicted of or plead guilty or nolo
  641  contendere to, regardless of adjudication, an offense that
  642  constitutes a felony for receipt of illicit and diverted drugs,
  643  including a controlled substance listed in Schedule I, Schedule
  644  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  645  this state, any other state, or the United States.
  646         (f) If the department finds that a pain-management clinic
  647  does not meet the requirement of paragraph (d) or is owned,
  648  directly or indirectly, by a person meeting any criteria listed
  649  in paragraph (e), the department shall revoke the certificate of
  650  registration previously issued by the department. As determined
  651  by rule, the department may grant an exemption to denying a
  652  registration or revoking a previously issued registration if
  653  more than 10 years have elapsed since adjudication. As used in
  654  this subsection, the term “convicted” includes an adjudication
  655  of guilt following a plea of guilty or nolo contendere or the
  656  forfeiture of a bond when charged with a crime.
  657         (g) The department may revoke the clinic’s certificate of
  658  registration and prohibit all physicians associated with that
  659  pain-management clinic from practicing at that clinic location
  660  based upon an annual inspection and evaluation of the factors
  661  described in subsection (3).
  662         (h)If the registration of a pain-management clinic is
  663  revoked or suspended, the designated physician of the pain
  664  management clinic, the owner or lessor of the pain-management
  665  clinic property, the manager, and the proprietor shall cease to
  666  operate the facility as a pain-management clinic as of the
  667  effective date of the suspension or revocation.
  668         (i)If a pain-management clinic registration is revoked or
  669  suspended, the designated physician of the pain-management
  670  clinic, the owner or lessor of the clinic property, the manager,
  671  or the proprietor is responsible for removing all signs and
  672  symbols identifying the premises as a pain-management clinic.
  673         (j)Upon the effective date of the suspension or
  674  revocation, the designated physician of the pain-management
  675  clinic shall advise the department of the disposition of the
  676  medicinal drugs located on the premises. The disposition is
  677  subject to the supervision and approval of the department.
  678  Medicinal drugs that are purchased or held by a pain–management
  679  clinic that is not registered may be deemed adulterated pursuant
  680  to s. 499.006.
  681         (k)If the clinic’s registration is revoked, any person
  682  named in the registration documents of the pain-management
  683  clinic, including persons owning or operating the pain
  684  management clinic, may not as an individual or as a part of a
  685  group, make application for a permit to operate a pain
  686  management clinic for 5 years after the date the registration is
  687  revoked.
  688         (l)The period of suspension for the registration of a pain
  689  management clinic shall be prescribed by the department, but may
  690  not exceed 1 year.
  691         (m) A change of ownership of a registered pain-management
  692  clinic requires submission of a new registration application.
  693         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  694  apply to any osteopathic physician who provides professional
  695  services in a pain-management clinic that is required to be
  696  registered in subsection (1).
  697         (a)An osteopathic physician may not practice medicine in a
  698  pain-management clinic, as described in subsection (4), if:
  699         1.The pain-management clinic is not registered with the
  700  department as required by this section; or
  701         2.Effective July 1, 2012, the physician has not
  702  successfully completed a pain medicine fellowship that is
  703  accredited by the Accreditation Council for Graduate Medical
  704  Education or the American Osteopathic Association or a pain
  705  medicine residency that is accredited by the Accreditation
  706  Council for Graduate Medical Education or the American
  707  Osteopathic Association or does not comply with rules adopted by
  708  the Board of Osteopathic Medicine.
  709  
  710  An osteopathic physician who violates this paragraph is subject
  711  to disciplinary action by his or her appropriate medical
  712  regulatory board.
  713         (b)A person may not dispense any medication, including a
  714  controlled substance, on the premises of a registered pain
  715  management clinic unless he or she is a physician licensed under
  716  this chapter or chapter 458.
  717         (c)An osteopathic physician must perform a physical
  718  examination of a patient on the same day that he or she
  719  dispenses or prescribes a controlled substance to a patient at a
  720  pain-management clinic. If the osteopathic physician prescribes
  721  or dispenses more than a 72-hour dose of controlled substances
  722  for the treatment of chronic nonmalignant pain, the osteopathic
  723  physician must document in the patient’s record the reason for
  724  prescribing or dispensing that quantity.
  725         (d) An osteopathic physician authorized to prescribe
  726  controlled substances who practices at a pain-management clinic
  727  is responsible for maintaining the control and security of his
  728  or her prescription blanks and any other method used for
  729  prescribing controlled substance pain medication. The
  730  osteopathic physician shall comply with the requirements for
  731  counterfeit-resistant prescription blanks in s. 893.065 and the
  732  rules adopted pursuant to that section. The osteopathic
  733  physician shall notify in writing the department within 24 hours
  734  following any theft or loss of a prescription blank or breach of
  735  any other method for prescribing pain medication.
  736         (e)The designated osteopathic physician of a pain
  737  management clinic shall notify the applicable board in writing
  738  of the date of termination of employment within 10 days after
  739  terminating his or her employment with a pain-management clinic
  740  that is required to be registered under subsection (1).
  741         (3) INSPECTION.—
  742         (a) The department shall inspect the pain-management clinic
  743  annually, including a review of the patient records, to ensure
  744  that it complies with this section and the rules of the Board of
  745  Osteopathic Medicine adopted pursuant to subsection (4) unless
  746  the clinic is accredited by a nationally recognized accrediting
  747  agency approved by the Board of Osteopathic Medicine.
  748         (b) During an onsite inspection, the department shall make
  749  a reasonable attempt to discuss each violation with the owner or
  750  designated physician of the pain-management clinic before
  751  issuing a formal written notification.
  752         (c) Any action taken to correct a violation shall be
  753  documented in writing by the owner or designated physician of
  754  the pain-management clinic and verified by followup visits by
  755  departmental personnel.
  756         (4) RULEMAKING.—
  757         (a) The department shall adopt rules necessary to
  758  administer the registration and inspection of pain-management
  759  clinics which establish the specific requirements, procedures,
  760  forms, and fees.
  761         (b) The department shall adopt a rule defining what
  762  constitutes practice by a designated osteopathic physician at
  763  the clinic location for which the physician has assumed
  764  responsibility, as set forth in subsection (1). When adopting
  765  the rule, the department shall consider the number of clinic
  766  employees, the location of the pain-management clinic, the
  767  clinic’s hours of operation, and the amount of controlled
  768  substances being prescribed, dispensed, or administered at the
  769  pain-management clinic.
  770         (c) The Board of Osteopathic Medicine shall adopt a rule
  771  establishing the maximum number of prescriptions for Schedule II
  772  or Schedule III controlled substances or the controlled
  773  substance Alprazolam which may be written at any one registered
  774  pain-management clinic during any 24-hour period.
  775         (d)The Board of Osteopathic Medicine shall adopt rules
  776  setting forth standards of practice for osteopathic physicians
  777  practicing in privately owned pain-management clinics that
  778  primarily engage in the treatment of pain by prescribing or
  779  dispensing controlled substance medications. Such rules shall
  780  address, but need not be limited to:
  781         1.Facility operations;
  782         2.Physical operations;
  783         3.Infection control requirements;
  784         4.Health and safety requirements;
  785         5.Quality assurance requirements;
  786         6.Patient records;
  787         7.Training requirements for all facility health care
  788  practitioners who are not regulated by another board;
  789         8.Inspections; and
  790         9.Data collection and reporting requirements.
  791  
  792  An osteopathic physician is primarily engaged in the treatment
  793  of pain by prescribing or dispensing controlled substance
  794  medications when the majority of the patients seen are
  795  prescribed or dispensed controlled substance medications for the
  796  treatment of chronic nonmalignant pain. Chronic nonmalignant
  797  pain is pain unrelated to cancer which persists beyond the usual
  798  course of the disease or the injury that is the cause of the
  799  pain or more than 90 days after surgery.
  800         (5) PENALTIES; ENFORCEMENT.—
  801         (a)The department may impose an administrative fine on the
  802  clinic of up to $5,000 per violation for violating the
  803  requirements of this section; chapter 499, the Florida Drug and
  804  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  805  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  806  Abuse Prevention and Control Act; chapter 893, the Florida
  807  Comprehensive Drug Abuse Prevention and Control Act; or the
  808  rules of the department. In determining whether a penalty is to
  809  be imposed, and in fixing the amount of the fine, the department
  810  shall consider the following factors:
  811         1. The gravity of the violation, including the probability
  812  that death or serious physical or emotional harm to a patient
  813  has resulted, or could have resulted, from the pain-management
  814  clinic’s actions or the actions of the osteopathic physician,
  815  the severity of the action or potential harm, and the extent to
  816  which the provisions of the applicable laws or rules were
  817  violated.
  818         2. What actions, if any, the owner or designated
  819  osteopathic physician took to correct the violations.
  820         3. Whether there were any previous violations at the pain
  821  management clinic.
  822         4. The financial benefits that the pain-management clinic
  823  derived from committing or continuing to commit the violation.
  824         (b) Each day a violation continues after the date fixed for
  825  termination of the violation as ordered by the department
  826  constitutes an additional, separate, and distinct violation.
  827         (c) The department may impose a fine and, in the case of an
  828  owner-operated pain-management clinic, revoke or deny a pain
  829  management clinic’s registration, if the clinic’s designated
  830  osteopathic physician knowingly and intentionally misrepresents
  831  actions taken to correct a violation.
  832         (d) An owner or designated osteopathic physician of a pain
  833  management clinic who concurrently operates an unregistered
  834  pain-management clinic is subject to an administrative fine of
  835  $5,000 per day.
  836         (e) If the owner of a pain-management clinic that requires
  837  registration fails to apply to register the clinic upon a
  838  change-of-ownership and operates the clinic under the new
  839  ownership, the owner is subject to a fine of $5,000.
  840         Section 9. Subsections (1) and (2) of section 459.013,
  841  Florida Statutes, are amended to read:
  842         459.013 Penalty for violations.—
  843         (1) Each of the following acts constitutes a felony of the
  844  third degree, punishable as provided in s. 775.082, s. 775.083,
  845  or s. 775.084:
  846         (a) The practice of osteopathic medicine, or an attempt to
  847  practice osteopathic medicine, without an active license or
  848  certificate issued pursuant to this chapter.
  849         (b) The practice of osteopathic medicine by a person
  850  holding a limited license, osteopathic faculty certificate, or
  851  other certificate issued under this chapter beyond the scope of
  852  practice authorized for such licensee or certificateholder.
  853         (c) Attempting to obtain or obtaining a license to practice
  854  osteopathic medicine by knowing misrepresentation.
  855         (d) Attempting to obtain or obtaining a position as an
  856  osteopathic medical practitioner or osteopathic medical resident
  857  in a clinic or hospital through knowing misrepresentation of
  858  education, training, or experience.
  859         (e)Knowingly operating, owning, or managing a
  860  nonregistered pain-management clinic that is required to be
  861  registered with the Department of Health pursuant to s.
  862  459.0137(1).
  863         (2) Each of the following acts constitutes a misdemeanor of
  864  the first degree, punishable as provided in s. 775.082 or s.
  865  775.083:
  866         (a) Knowingly concealing information relating to violations
  867  of this chapter.
  868         (b) Making any willfully false oath or affirmation whenever
  869  an oath or affirmation is required by this chapter.
  870         (c) The practice of medicine as a resident or intern
  871  without holding a valid current registration pursuant to s.
  872  459.021.
  873         (d) Knowingly prescribing or dispensing, or causing to be
  874  prescribed or dispensed, controlled substances in a
  875  nonregistered pain-management clinic that is required to be
  876  registered with the Department of Health pursuant to s.
  877  459.0137(1).
  878         Section 10. Paragraphs (qq) and (rr) are added to
  879  subsection (1) of section 459.015, Florida Statutes, to read:
  880         459.015 Grounds for disciplinary action; action by the
  881  board and department.—
  882         (1) The following acts constitute grounds for denial of a
  883  license or disciplinary action, as specified in s. 456.072(2):
  884         (qq) Applicable to a licensee who serves as the designated
  885  physician of a pain-management clinic as defined in s. 458.3265
  886  or s. 459.0137:
  887         1.Registering a pain-management clinic through
  888  misrepresentation or fraud;
  889         2.Procuring, or attempting to procure, the registration of
  890  a pain-management clinic for any other person by making or
  891  causing to be made, any false representation;
  892         3.Failing to comply with any requirement of chapter 499,
  893  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  894  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  895  the Drug Abuse Prevention and Control Act; or chapter 893, the
  896  Florida Comprehensive Drug Abuse Prevention and Control Act;
  897         4.Being convicted or found guilty of, regardless of
  898  adjudication to, a felony or any other crime involving moral
  899  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  900  the courts of this state, of any other state, or of the United
  901  States;
  902         5.Being convicted of, or disciplined by a regulatory
  903  agency of the Federal Government or a regulatory agency of
  904  another state for any offense that would constitute a violation
  905  of this chapter;
  906         6.Being convicted of, or entering a plea of guilty or nolo
  907  contendere to, regardless of adjudication, a crime in any
  908  jurisdiction of the courts of this state, of any other state, or
  909  of the United States which relates to the practice of, or the
  910  ability to practice, a licensed health care profession;
  911         7.Being convicted of, or entering a plea of guilty or nolo
  912  contendere to, regardless of adjudication, a crime in any
  913  jurisdiction of the courts of this state, of any other state, or
  914  of the United States which relates to health care fraud;
  915         8.Dispensing any medicinal drug based upon a communication
  916  that purports to be a prescription as defined in s. 465.003(14)
  917  or s. 893.02 if the dispensing practitioner knows or has reason
  918  to believe that the purported prescription is not based upon a
  919  valid practitioner-patient relationship; or
  920         9.Failing to timely notify the board of the date of his or
  921  her termination from a pain-management clinic as required by s.
  922  459.0137(2).
  923         (rr)Failing to timely notify the department of the theft
  924  of prescription blanks from a pain-management clinic or a breach
  925  of other methods for prescribing within 24 hours as required by
  926  s. 459.0137(2).
  927         Section 11. Paragraph (b) of subsection (7) of section
  928  893.055, Florida Statutes, is amended to read:
  929         893.055 Prescription drug monitoring program.—
  930         (7)
  931         (b)1. A pharmacy, prescriber, or dispenser shall have
  932  access to information in the prescription drug monitoring
  933  program’s database which relates to a patient of that pharmacy,
  934  prescriber, or dispenser in a manner established by the
  935  department as needed for the purpose of reviewing the patient’s
  936  controlled substance prescription history.
  937         2.The prescription drug monitoring program’s database
  938  shall report information directly to applicable law enforcement
  939  agencies to investigate whether any violation of s.
  940  893.13(7)(a)8., s. 893.13(8)(a), or s. 893.13(8)(b), has
  941  occurred regarding controlled substances in Schedule II,
  942  Schedule III, or Schedule IV. The department shall adopt rules
  943  to identify the factors that might be indicative of a violation
  944  of s. 893.13(7)(a)8., s. 893.13(8)(a), or s. 893.13(8)(b), based
  945  on input from the Department of Law Enforcement and
  946  representatives of local law enforcement, the Florida Medical
  947  Association, the Florida Osteopathic Medical Association, the
  948  Florida Pharmacy Association, and other relevant stakeholders.
  949         3. Other access to the program’s database shall be limited
  950  to the program’s manager and to the designated program and
  951  support staff, who may act only at the direction of the program
  952  manager or, in the absence of the program manager, as
  953  authorized. Access by the program manager or such designated
  954  staff is for prescription drug program management only or for
  955  management of the program’s database and its system in support
  956  of the requirements of this section and in furtherance of the
  957  prescription drug monitoring program. Confidential and exempt
  958  information in the database shall be released only as provided
  959  in paragraph (c) and s. 893.0551.
  960         Section 12. Subsections (4), (5), and (6) of section
  961  893.0551, Florida Statutes, are renumbered as subsections (5),
  962  (6), and (7), respectively, and subsection (4) is added to that
  963  section, to read:
  964         893.0551 Public records exemption for the prescription drug
  965  monitoring program.—
  966         (4) The department shall disclose such confidential and
  967  exempt information to the applicable law enforcement agency in
  968  accordance with s. 893.055(7)(b)2. The law enforcement agency
  969  may disclose the confidential and exempt information received
  970  from the department to a criminal justice agency as defined in
  971  s. 119.011 as part of an active investigation that is specific
  972  to a violation of s. 893.13(7)(a)8., s. 893.13(8)(a), or s.
  973  893.13(8)(b).
  974         Section 13. This act shall take effect October 1, 2010.

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