October 17, 2019
Print This PagePrint This Page

  *
Session:
Bill #:
Session:
Chamber: View Search Tips
Search Term:
Year: View Search Tips
Search Term:
       CS for CS for SB 2272 & CS for SB 2722           First Engrossed
       
       
       
       
       
       
       
       
       20102272e1
       
    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         defining the term “program manager”; requiring that
  125         the program manager work with certain licensure boards
  126         and stakeholders to develop rules; authorizing the
  127         program manager to provide relevant information to law
  128         enforcement agencies under certain circumstances;
  129         amending s. 893.0551, F.S.; providing for disclosure
  130         of confidential and exempt information to applicable
  131         law enforcement; providing an effective 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 clinic is owned by a publicly held corporation whose
  232  shares are traded on a national exchange or on the over-the
  233  counter market and whose total assets at the end of the
  234  corporation’s most recent fiscal quarter exceeded $50 million;
  235         4. The clinic is affiliated with an accredited medical
  236  school at which training is provided for medical students,
  237  residents, or fellows;
  238         5. The clinic does not prescribe or dispense controlled
  239  substances for the treatment of pain; or
  240         6. The clinic is owned by a corporate entity exempt from
  241  federal taxation under 26 U.S.C. s. 501(c)(3).
  242         (b) Each clinic location shall be registered separately
  243  regardless of whether the clinic is operated under the same
  244  business name or management as another clinic.
  245         (c) As a part of registration, a clinic must designate a
  246  physician who is responsible for complying with all requirements
  247  related to registration and operation of the clinic in
  248  compliance with this section. Within 10 days after termination
  249  of a designated physician, the clinic must notify the department
  250  of the identity of another designated physician for that clinic.
  251  The designated physician shall have a full, active, and
  252  unencumbered license under this chapter or chapter 459 and shall
  253  practice at the clinic location for which the physician has
  254  assumed responsibility. Failing to have a licensed designated
  255  physician practicing at the location of the registered clinic
  256  may be the basis for a summary suspension of the clinic
  257  registration certificate as described in s. 456.073(8) for a
  258  license or s. 120.60(6).
  259         (d)The department shall deny registration to any clinic
  260  that is not fully owned by a physician licensed under this
  261  chapter or chapter 459 or a group of physicians, each of whom is
  262  licensed under this chapter or chapter 459; or that is not a
  263  health care clinic licensed under part X of chapter 400.
  264         (e) The department shall deny registration to any pain
  265  management clinic owned by or with any contractual or employment
  266  relationship with a physician:
  267         1. Whose Drug Enforcement Administration number has ever
  268  been revoked.
  269         2. Whose application for a license to prescribe, dispense,
  270  or administer a controlled substance has been denied by any
  271  jurisdiction.
  272         3. Who has been convicted of or plead guilty or nolo
  273  contendere to, regardless of adjudication, an offense that
  274  constitutes a felony for receipt of illicit and diverted drugs,
  275  including a controlled substance listed in Schedule I, Schedule
  276  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  277  this state, any other state, or the United States.
  278         (f) If the department finds that a pain-management clinic
  279  does not meet the requirement of paragraph (d) or is owned,
  280  directly or indirectly, by a person meeting any criteria listed
  281  in paragraph (e), the department shall revoke the certificate of
  282  registration previously issued by the department. As determined
  283  by rule, the department may grant an exemption to denying a
  284  registration or revoking a previously issued registration if
  285  more than 10 years have elapsed since adjudication. As used in
  286  this subsection, the term “convicted” includes an adjudication
  287  of guilt following a plea of guilty or nolo contendere or the
  288  forfeiture of a bond when charged with a crime.
  289         (g) The department may revoke the clinic’s certificate of
  290  registration and prohibit all physicians associated with that
  291  pain-management clinic from practicing at that clinic location
  292  based upon an annual inspection and evaluation of the factors
  293  described in subsection (3).
  294         (h)If the registration of a pain-management clinic is
  295  revoked or suspended, the designated physician of the pain
  296  management clinic, the owner or lessor of the pain-management
  297  clinic property, the manager, and the proprietor shall cease to
  298  operate the facility as a pain-management clinic as of the
  299  effective date of the suspension or revocation.
  300         (i)If a pain-management clinic registration is revoked or
  301  suspended, the designated physician of the pain-management
  302  clinic, the owner or lessor of the clinic property, the manager,
  303  or the proprietor is responsible for removing all signs and
  304  symbols identifying the premises as a pain-management clinic.
  305         (j)Upon the effective date of the suspension or
  306  revocation, the designated physician of the pain-management
  307  clinic shall advise the department of the disposition of the
  308  medicinal drugs located on the premises. The disposition is
  309  subject to the supervision and approval of the department.
  310  Medicinal drugs that are purchased or held by a pain–management
  311  clinic that is not registered may be deemed adulterated pursuant
  312  to s. 499.006.
  313         (k)If the clinic’s registration is revoked, any person
  314  named in the registration documents of the pain-management
  315  clinic, including persons owning or operating the pain
  316  management clinic, may not, as an individual or as a part of a
  317  group, apply to operate a pain-management clinic for 5 years
  318  after the date the registration is revoked.
  319         (l)The period of suspension for the registration of a pain
  320  management clinic shall be prescribed by the department, but may
  321  not exceed 1 year.
  322         (m) A change of ownership of a registered pain-management
  323  clinic requires submission of a new registration application.
  324         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  325  apply to any physician who provides professional services in a
  326  pain-management clinic that is required to be registered in
  327  subsection (1).
  328         (a)A physician may not practice medicine in a pain
  329  management clinic, as described in subsection (4), if:
  330         1.The pain-management clinic is not registered with the
  331  department as required by this section; or
  332         2.Effective July 1, 2012, the physician has not
  333  successfully completed a pain medicine fellowship that is
  334  accredited by the Accreditation Council for Graduate Medical
  335  Education or a pain medicine residency that is accredited by the
  336  Accreditation Council for Graduate Medical Education or, prior
  337  to July 1, 2012, does not comply with rules adopted by the
  338  board.
  339  
  340  Any physician who qualifies to practice medicine in a pain
  341  management clinic pursuant to rules adopted by the Board of
  342  Medicine as of July 1, 2012, may continue to practice medicine
  343  in a pain-management clinic as long as the physician continues
  344  to meet the qualifications set forth in the board rules. A
  345  physician who violates this paragraph is subject to disciplinary
  346  action by his or her appropriate medical regulatory board.
  347         (b)A person may not dispense any medication, including a
  348  controlled substance, on the premises of a registered pain
  349  management clinic unless he or she is a physician licensed under
  350  this chapter or chapter 459.
  351         (c)A physician must perform a physical examination of a
  352  patient on the same day that he or she dispenses or prescribes a
  353  controlled substance to a patient at a pain-management clinic.
  354  If the physician prescribes or dispenses more than a 72-hour
  355  dose of controlled substances for the treatment of chronic
  356  nonmalignant pain, the physician must document in the patient’s
  357  record the reason for prescribing or dispensing that quantity.
  358         (d) A physician authorized to prescribe controlled
  359  substances who practices at a pain-management clinic is
  360  responsible for maintaining the control and security of his or
  361  her prescription blanks and any other method used for
  362  prescribing controlled substance pain medication. The physician
  363  shall comply with the requirements for counterfeit-resistant
  364  prescription blanks in s. 893.065 and the rules adopted pursuant
  365  to that section. The physician shall notify in writing the
  366  department within 24 hours following any theft or loss of a
  367  prescription blank or breach of any other method for prescribing
  368  pain medication.
  369         (e)The designated physician of a pain-management clinic
  370  shall notify the applicable board in writing of the date of
  371  termination of employment within 10 days after terminating his
  372  or her employment with a pain-management clinic that is required
  373  to be registered under subsection (1).
  374         (3) INSPECTION.—
  375         (a) The department shall inspect the pain-management clinic
  376  annually, including a review of the patient records, to ensure
  377  that it complies with this section and the rules of the Board of
  378  Medicine adopted pursuant to subsection (4) unless the clinic is
  379  accredited by a nationally recognized accrediting agency
  380  approved by the Board of Medicine.
  381         (b) During an onsite inspection, the department shall make
  382  a reasonable attempt to discuss each violation with the owner or
  383  designated physician of the pain-management clinic before
  384  issuing a formal written notification.
  385         (c) Any action taken to correct a violation shall be
  386  documented in writing by the owner or designated physician of
  387  the pain-management clinic and verified by followup visits by
  388  departmental personnel.
  389         (4) RULEMAKING.—
  390         (a) The department shall adopt rules necessary to
  391  administer the registration and inspection of pain-management
  392  clinics which establish the specific requirements, procedures,
  393  forms, and fees.
  394         (b) The department shall adopt a rule defining what
  395  constitutes practice by a designated physician at the clinic
  396  location for which the physician has assumed responsibility, as
  397  set forth in subsection (1). When adopting the rule, the
  398  department shall consider the number of clinic employees, the
  399  location of the pain-management clinic, the clinic’s hours of
  400  operation, and the amount of controlled substances being
  401  prescribed, dispensed, or administered at the pain-management
  402  clinic.
  403         (c) The Board of Medicine shall adopt a rule establishing
  404  the maximum number of prescriptions for Schedule II or Schedule
  405  III controlled substances or the controlled substance Alprazolam
  406  which may be written at any one registered pain-management
  407  clinic during any 24-hour period.
  408         (d)The Board of Medicine shall adopt rules setting forth
  409  standards of practice for physicians practicing in privately
  410  owned pain-management clinics that primarily engage in the
  411  treatment of pain by prescribing or dispensing controlled
  412  substance medications. Such rules shall address, but need not be
  413  limited to:
  414         1.Facility operations;
  415         2.Physical operations;
  416         3.Infection control requirements;
  417         4.Health and safety requirements;
  418         5.Quality assurance requirements;
  419         6.Patient records;
  420         7.Training requirements for all facility health care
  421  practitioners who are not regulated by another board;
  422         8.Inspections; and
  423         9.Data collection and reporting requirements.
  424  
  425  A physician is primarily engaged in the treatment of pain by
  426  prescribing or dispensing controlled substance medications when
  427  the majority of the patients seen are prescribed or dispensed
  428  controlled substance medications for the treatment of chronic
  429  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  430  to cancer which persists beyond the usual course of the disease
  431  or the injury that is the cause of the pain or more than 90 days
  432  after surgery.
  433         (5) PENALTIES; ENFORCEMENT.—
  434         (a)The department may impose an administrative fine on the
  435  clinic of up to $5,000 per violation for violating the
  436  requirements of this section; chapter 499, the Florida Drug and
  437  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  438  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  439  Abuse Prevention and Control Act; chapter 893, the Florida
  440  Comprehensive Drug Abuse Prevention and Control Act; or the
  441  rules of the department. In determining whether a penalty is to
  442  be imposed, and in fixing the amount of the fine, the department
  443  shall consider the following factors:
  444         1. The gravity of the violation, including the probability
  445  that death or serious physical or emotional harm to a patient
  446  has resulted, or could have resulted, from the pain-management
  447  clinic’s actions or the actions of the physician, the severity
  448  of the action or potential harm, and the extent to which the
  449  provisions of the applicable laws or rules were violated.
  450         2. What actions, if any, the owner or designated physician
  451  took to correct the violations.
  452         3. Whether there were any previous violations at the pain
  453  management clinic.
  454         4. The financial benefits that the pain-management clinic
  455  derived from committing or continuing to commit the violation.
  456         (b) Each day a violation continues after the date fixed for
  457  termination of the violation as ordered by the department
  458  constitutes an additional, separate, and distinct violation.
  459         (c) The department may impose a fine and, in the case of an
  460  owner-operated pain-management clinic, revoke or deny a pain
  461  management clinic’s registration, if the clinic’s designated
  462  physician knowingly and intentionally misrepresents actions
  463  taken to correct a violation.
  464         (d) An owner or designated physician of a pain-management
  465  clinic who concurrently operates an unregistered pain-management
  466  clinic is subject to an administrative fine of $5,000 per day.
  467         (e) If the owner of a pain-management clinic that requires
  468  registration fails to apply to register the clinic upon a
  469  change-of-ownership and operates the clinic under the new
  470  ownership, the owner is subject to a fine of $5,000.
  471         Section 5. Section 458.327, Florida Statutes, is amended to
  472  read:
  473         458.327 Penalty for violations.—
  474         (1) Each of the following acts constitutes a felony of the
  475  third degree, punishable as provided in s. 775.082, s. 775.083,
  476  or s. 775.084:
  477         (a) The practice of medicine or an attempt to practice
  478  medicine without a license to practice in Florida.
  479         (b) The use or attempted use of a license which is
  480  suspended or revoked to practice medicine.
  481         (c) Attempting to obtain or obtaining a license to practice
  482  medicine by knowing misrepresentation.
  483         (d) Attempting to obtain or obtaining a position as a
  484  medical practitioner or medical resident in a clinic or hospital
  485  through knowing misrepresentation of education, training, or
  486  experience.
  487         (e)Knowingly operating, owning, or managing a
  488  nonregistered pain-management clinic that is required to be
  489  registered with the Department of Health pursuant to s.
  490  458.3265(1).
  491         (2) Each of the following acts constitutes a misdemeanor of
  492  the first degree, punishable as provided in s. 775.082 or s.
  493  775.083:
  494         (a) Knowingly concealing information relating to violations
  495  of this chapter.
  496         (b) Making any willfully false oath or affirmation whenever
  497  an oath or affirmation is required by this chapter.
  498         (c) Referring any patient, for health care goods or
  499  services, to a partnership, firm, corporation, or other business
  500  entity in which the physician or the physician’s employer has an
  501  equity interest of 10 percent or more unless, prior to such
  502  referral, the physician notifies the patient of his or her
  503  financial interest and of the patient’s right to obtain such
  504  goods or services at the location of the patient’s choice. This
  505  section does not apply to the following types of equity
  506  interest:
  507         1. The ownership of registered securities issued by a
  508  publicly held corporation or the ownership of securities issued
  509  by a publicly held corporation, the shares of which are traded
  510  on a national exchange or the over-the-counter market;
  511         2. A physician’s own practice, whether he or she is a sole
  512  practitioner or part of a group, when the health care good or
  513  service is prescribed or provided solely for the physician’s own
  514  patients and is provided or performed by the physician or under
  515  the physician’s supervision; or
  516         3. An interest in real property resulting in a landlord
  517  tenant relationship between the physician and the entity in
  518  which the equity interest is held, unless the rent is
  519  determined, in whole or in part, by the business volume or
  520  profitability of the tenant or is otherwise unrelated to fair
  521  market value.
  522         (d) Leading the public to believe that one is licensed as a
  523  medical doctor, or is engaged in the licensed practice of
  524  medicine, without holding a valid, active license.
  525         (e) Practicing medicine or attempting to practice medicine
  526  with an inactive or delinquent license.
  527         (f) Knowingly prescribing or dispensing, or causing to be
  528  prescribed or dispensed, controlled substances in a
  529  nonregistered pain-management clinic that is required to be
  530  registered with the Department of Health pursuant to s.
  531  458.3265(1).
  532         Section 6. Paragraphs (oo) and (pp) are added to subsection
  533  (1) of section 458.331, Florida Statutes, to read:
  534         458.331 Grounds for disciplinary action; action by the
  535  board and department.—
  536         (1) The following acts constitute grounds for denial of a
  537  license or disciplinary action, as specified in s. 456.072(2):
  538         (oo) Applicable to a licensee who serves as the designated
  539  physician of a pain-management clinic as defined in s. 458.3265
  540  or s. 459.0137:
  541         1.Registering a pain-management clinic through
  542  misrepresentation or fraud;
  543         2.Procuring, or attempting to procure, the registration of
  544  a pain-management clinic for any other person by making or
  545  causing to be made, any false representation;
  546         3.Failing to comply with any requirement of chapter 499,
  547  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  548  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  549  the Drug Abuse Prevention and Control Act; or chapter 893, the
  550  Florida Comprehensive Drug Abuse Prevention and Control Act;
  551         4.Being convicted or found guilty of, regardless of
  552  adjudication to, a felony or any other crime involving moral
  553  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  554  the courts of this state, of any other state, or of the United
  555  States;
  556         5.Being convicted of, or disciplined by a regulatory
  557  agency of the Federal Government or a regulatory agency of
  558  another state for any offense that would constitute a violation
  559  of this chapter;
  560         6.Being convicted of, or entering a plea of guilty or nolo
  561  contendere to, regardless of adjudication, a crime in any
  562  jurisdiction of the courts of this state, of any other state, or
  563  of the United States which relates to the practice of, or the
  564  ability to practice, a licensed health care profession;
  565         7.Being convicted of, or entering a plea of guilty or nolo
  566  contendere to, regardless of adjudication, a crime in any
  567  jurisdiction of the courts of this state, of any other state, or
  568  of the United States which relates to health care fraud;
  569         8.Dispensing any medicinal drug based upon a communication
  570  that purports to be a prescription as defined in s. 465.003(14)
  571  or s. 893.02 if the dispensing practitioner knows or has reason
  572  to believe that the purported prescription is not based upon a
  573  valid practitioner-patient relationship; or
  574         9.Failing to timely notify the board of the date of his or
  575  her termination from a pain-management clinic as required by s.
  576  458.3265(2).
  577         (pp)Failing to timely notify the department of the theft
  578  of prescription blanks from a pain-management clinic or a breach
  579  of other methods for prescribing within 24 hours as required by
  580  s. 458.3265(2).
  581         Section 7. Subsections (3), (4), and (5) of section
  582  459.005, Florida Statutes, are repealed.
  583         Section 8. Section 459.0137, Florida Statutes, is created
  584  to read:
  585         459.0137Pain-management clinics.—
  586         (1)REGISTRATION.—
  587         (a) All privately owned pain-management clinics,
  588  facilities, or offices, hereinafter referred to as “clinics,”
  589  which advertise in any medium for any type of pain-management
  590  services, or employ an osteopathic physician who is primarily
  591  engaged in the treatment of pain by prescribing or dispensing
  592  controlled substance medications, must register with the
  593  department unless:
  594         1. That clinic is licensed as a facility pursuant to
  595  chapter 395;
  596         2. The majority of the physicians who provide services in
  597  the clinic primarily provide surgical services;
  598         3.The clinic is owned by a publicly held corporation whose
  599  shares are traded on a national exchange or on the over-the
  600  counter market and whose total assets at the end of the
  601  corporation’s most recent fiscal quarter exceeded $50 million;
  602         4.The clinic is affiliated with an accredited medical
  603  school at which training is provided for medical students,
  604  residents, or fellows;
  605         5. The clinic does not prescribe or dispense controlled
  606  substances for the treatment of pain; or
  607         6. The clinic is owned by a corporate entity exempt from
  608  federal taxation under 26 U.S.C. s. 501(c)(3).
  609         (b) Each clinic location shall be registered separately
  610  regardless of whether the clinic is operated under the same
  611  business name or management as another clinic.
  612         (c) As a part of registration, a clinic must designate an
  613  osteopathic physician who is responsible for complying with all
  614  requirements related to registration and operation of the clinic
  615  in compliance with this section. Within 10 days after
  616  termination of a designated osteopathic physician, the clinic
  617  must notify the department of the identity of another designated
  618  physician for that clinic. The designated physician shall have a
  619  full, active, and unencumbered license under chapter 458 or this
  620  chapter and shall practice at the clinic location for which the
  621  physician has assumed responsibility. Failing to have a licensed
  622  designated osteopathic physician practicing at the location of
  623  the registered clinic may be the basis for a summary suspension
  624  of the clinic registration certificate as described in s.
  625  456.073(8) for a license or s. 120.60(6).
  626         (d)The department shall deny registration to any clinic
  627  that is not fully owned by a physician licensed under chapter
  628  458 or this chapter or a group of physicians, each of whom is
  629  licensed under chapter 458 or this chapter; or that is not a
  630  health care clinic licensed under part X of chapter 400.
  631         (e) The department shall deny registration to any pain
  632  management clinic owned by or with any contractual or employment
  633  relationship with a physician:
  634         1. Whose Drug Enforcement Administration number has ever
  635  been revoked.
  636         2. Whose application for a license to prescribe, dispense,
  637  or administer a controlled substance has been denied by any
  638  jurisdiction.
  639         3. Who has been convicted of or plead guilty or nolo
  640  contendere to, regardless of adjudication, an offense that
  641  constitutes a felony for receipt of illicit and diverted drugs,
  642  including a controlled substance listed in Schedule I, Schedule
  643  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  644  this state, any other state, or the United States.
  645         (f) If the department finds that a pain-management clinic
  646  does not meet the requirement of paragraph (d) or is owned,
  647  directly or indirectly, by a person meeting any criteria listed
  648  in paragraph (e), the department shall revoke the certificate of
  649  registration previously issued by the department. As determined
  650  by rule, the department may grant an exemption to denying a
  651  registration or revoking a previously issued registration if
  652  more than 10 years have elapsed since adjudication. As used in
  653  this subsection, the term “convicted” includes an adjudication
  654  of guilt following a plea of guilty or nolo contendere or the
  655  forfeiture of a bond when charged with a crime.
  656         (g) The department may revoke the clinic’s certificate of
  657  registration and prohibit all physicians associated with that
  658  pain-management clinic from practicing at that clinic location
  659  based upon an annual inspection and evaluation of the factors
  660  described in subsection (3).
  661         (h)If the registration of a pain-management clinic is
  662  revoked or suspended, the designated physician of the pain
  663  management clinic, the owner or lessor of the pain-management
  664  clinic property, the manager, and the proprietor shall cease to
  665  operate the facility as a pain-management clinic as of the
  666  effective date of the suspension or revocation.
  667         (i)If a pain-management clinic registration is revoked or
  668  suspended, the designated physician of the pain-management
  669  clinic, the owner or lessor of the clinic property, the manager,
  670  or the proprietor is responsible for removing all signs and
  671  symbols identifying the premises as a pain-management clinic.
  672         (j)Upon the effective date of the suspension or
  673  revocation, the designated physician of the pain-management
  674  clinic shall advise the department of the disposition of the
  675  medicinal drugs located on the premises. The disposition is
  676  subject to the supervision and approval of the department.
  677  Medicinal drugs that are purchased or held by a pain–management
  678  clinic that is not registered may be deemed adulterated pursuant
  679  to s. 499.006.
  680         (k)If the clinic’s registration is revoked, any person
  681  named in the registration documents of the pain-management
  682  clinic, including persons owning or operating the pain
  683  management clinic, may not as an individual or as a part of a
  684  group, make application for a permit to operate a pain
  685  management clinic for 5 years after the date the registration is
  686  revoked.
  687         (l)The period of suspension for the registration of a pain
  688  management clinic shall be prescribed by the department, but may
  689  not exceed 1 year.
  690         (m) A change of ownership of a registered pain-management
  691  clinic requires submission of a new registration application.
  692         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  693  apply to any osteopathic physician who provides professional
  694  services in a pain-management clinic that is required to be
  695  registered in subsection (1).
  696         (a)An osteopathic physician may not practice medicine in a
  697  pain-management clinic, as described in subsection (4), if:
  698         1.The pain-management clinic is not registered with the
  699  department as required by this section; or
  700         2.Effective July 1, 2012, the physician has not
  701  successfully completed a pain medicine fellowship that is
  702  accredited by the Accreditation Council for Graduate Medical
  703  Education or the American Osteopathic Association or a pain
  704  medicine residency that is accredited by the Accreditation
  705  Council for Graduate Medical Education or the American
  706  Osteopathic Association or, prior to July 1, 2012, does not
  707  comply with rules adopted by the board.
  708  
  709  Any physician who qualifies to practice medicine in a pain
  710  management clinic pursuant to rules adopted by the Board of
  711  Osteopathic Medicine as of July 1, 2012, may continue to
  712  practice medicine in a pain-management clinic as long as the
  713  physician continues to meet the qualifications set forth in the
  714  board rules. An osteopathic physician who violates this
  715  paragraph is subject to disciplinary action by his or her
  716  appropriate medical regulatory board.
  717         (b)A person may not dispense any medication, including a
  718  controlled substance, on the premises of a registered pain
  719  management clinic unless he or she is a physician licensed under
  720  this chapter or chapter 458.
  721         (c)An osteopathic physician must perform a physical
  722  examination of a patient on the same day that he or she
  723  dispenses or prescribes a controlled substance to a patient at a
  724  pain-management clinic. If the osteopathic physician prescribes
  725  or dispenses more than a 72-hour dose of controlled substances
  726  for the treatment of chronic nonmalignant pain, the osteopathic
  727  physician must document in the patient’s record the reason for
  728  prescribing or dispensing that quantity.
  729         (d) An osteopathic physician authorized to prescribe
  730  controlled substances who practices at a pain-management clinic
  731  is responsible for maintaining the control and security of his
  732  or her prescription blanks and any other method used for
  733  prescribing controlled substance pain medication. The
  734  osteopathic physician shall comply with the requirements for
  735  counterfeit-resistant prescription blanks in s. 893.065 and the
  736  rules adopted pursuant to that section. The osteopathic
  737  physician shall notify in writing the department within 24 hours
  738  following any theft or loss of a prescription blank or breach of
  739  any other method for prescribing pain medication.
  740         (e)The designated osteopathic physician of a pain
  741  management clinic shall notify the applicable board in writing
  742  of the date of termination of employment within 10 days after
  743  terminating his or her employment with a pain-management clinic
  744  that is required to be registered under subsection (1).
  745         (3) INSPECTION.—
  746         (a) The department shall inspect the pain-management clinic
  747  annually, including a review of the patient records, to ensure
  748  that it complies with this section and the rules of the Board of
  749  Osteopathic Medicine adopted pursuant to subsection (4) unless
  750  the clinic is accredited by a nationally recognized accrediting
  751  agency approved by the Board of Osteopathic Medicine.
  752         (b) During an onsite inspection, the department shall make
  753  a reasonable attempt to discuss each violation with the owner or
  754  designated physician of the pain-management clinic before
  755  issuing a formal written notification.
  756         (c) Any action taken to correct a violation shall be
  757  documented in writing by the owner or designated physician of
  758  the pain-management clinic and verified by followup visits by
  759  departmental personnel.
  760         (4) RULEMAKING.—
  761         (a) The department shall adopt rules necessary to
  762  administer the registration and inspection of pain-management
  763  clinics which establish the specific requirements, procedures,
  764  forms, and fees.
  765         (b) The department shall adopt a rule defining what
  766  constitutes practice by a designated osteopathic physician at
  767  the clinic location for which the physician has assumed
  768  responsibility, as set forth in subsection (1). When adopting
  769  the rule, the department shall consider the number of clinic
  770  employees, the location of the pain-management clinic, the
  771  clinic’s hours of operation, and the amount of controlled
  772  substances being prescribed, dispensed, or administered at the
  773  pain-management clinic.
  774         (c) The Board of Osteopathic Medicine shall adopt a rule
  775  establishing the maximum number of prescriptions for Schedule II
  776  or Schedule III controlled substances or the controlled
  777  substance Alprazolam which may be written at any one registered
  778  pain-management clinic during any 24-hour period.
  779         (d)The Board of Osteopathic Medicine shall adopt rules
  780  setting forth standards of practice for osteopathic physicians
  781  practicing in privately owned pain-management clinics that
  782  primarily engage in the treatment of pain by prescribing or
  783  dispensing controlled substance medications. Such rules shall
  784  address, but need not be limited to:
  785         1.Facility operations;
  786         2.Physical operations;
  787         3.Infection control requirements;
  788         4.Health and safety requirements;
  789         5.Quality assurance requirements;
  790         6.Patient records;
  791         7.Training requirements for all facility health care
  792  practitioners who are not regulated by another board;
  793         8.Inspections; and
  794         9.Data collection and reporting requirements.
  795  
  796  An osteopathic physician is primarily engaged in the treatment
  797  of pain by prescribing or dispensing controlled substance
  798  medications when the majority of the patients seen are
  799  prescribed or dispensed controlled substance medications for the
  800  treatment of chronic nonmalignant pain. Chronic nonmalignant
  801  pain is pain unrelated to cancer which persists beyond the usual
  802  course of the disease or the injury that is the cause of the
  803  pain or more than 90 days after surgery.
  804         (5) PENALTIES; ENFORCEMENT.—
  805         (a)The department may impose an administrative fine on the
  806  clinic of up to $5,000 per violation for violating the
  807  requirements of this section; chapter 499, the Florida Drug and
  808  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  809  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  810  Abuse Prevention and Control Act; chapter 893, the Florida
  811  Comprehensive Drug Abuse Prevention and Control Act; or the
  812  rules of the department. In determining whether a penalty is to
  813  be imposed, and in fixing the amount of the fine, the department
  814  shall consider the following factors:
  815         1. The gravity of the violation, including the probability
  816  that death or serious physical or emotional harm to a patient
  817  has resulted, or could have resulted, from the pain-management
  818  clinic’s actions or the actions of the osteopathic physician,
  819  the severity of the action or potential harm, and the extent to
  820  which the provisions of the applicable laws or rules were
  821  violated.
  822         2. What actions, if any, the owner or designated
  823  osteopathic physician took to correct the violations.
  824         3. Whether there were any previous violations at the pain
  825  management clinic.
  826         4. The financial benefits that the pain-management clinic
  827  derived from committing or continuing to commit the violation.
  828         (b) Each day a violation continues after the date fixed for
  829  termination of the violation as ordered by the department
  830  constitutes an additional, separate, and distinct violation.
  831         (c) The department may impose a fine and, in the case of an
  832  owner-operated pain-management clinic, revoke or deny a pain
  833  management clinic’s registration, if the clinic’s designated
  834  osteopathic physician knowingly and intentionally misrepresents
  835  actions taken to correct a violation.
  836         (d) An owner or designated osteopathic physician of a pain
  837  management clinic who concurrently operates an unregistered
  838  pain-management clinic is subject to an administrative fine of
  839  $5,000 per day.
  840         (e) If the owner of a pain-management clinic that requires
  841  registration fails to apply to register the clinic upon a
  842  change-of-ownership and operates the clinic under the new
  843  ownership, the owner is subject to a fine of $5,000.
  844         Section 9. Subsections (1) and (2) of section 459.013,
  845  Florida Statutes, are amended to read:
  846         459.013 Penalty for violations.—
  847         (1) Each of the following acts constitutes a felony of the
  848  third degree, punishable as provided in s. 775.082, s. 775.083,
  849  or s. 775.084:
  850         (a) The practice of osteopathic medicine, or an attempt to
  851  practice osteopathic medicine, without an active license or
  852  certificate issued pursuant to this chapter.
  853         (b) The practice of osteopathic medicine by a person
  854  holding a limited license, osteopathic faculty certificate, or
  855  other certificate issued under this chapter beyond the scope of
  856  practice authorized for such licensee or certificateholder.
  857         (c) Attempting to obtain or obtaining a license to practice
  858  osteopathic medicine by knowing misrepresentation.
  859         (d) Attempting to obtain or obtaining a position as an
  860  osteopathic medical practitioner or osteopathic medical resident
  861  in a clinic or hospital through knowing misrepresentation of
  862  education, training, or experience.
  863         (e)Knowingly operating, owning, or managing a
  864  nonregistered pain-management clinic that is required to be
  865  registered with the Department of Health pursuant to s.
  866  459.0137(1).
  867         (2) Each of the following acts constitutes a misdemeanor of
  868  the first degree, punishable as provided in s. 775.082 or s.
  869  775.083:
  870         (a) Knowingly concealing information relating to violations
  871  of this chapter.
  872         (b) Making any willfully false oath or affirmation whenever
  873  an oath or affirmation is required by this chapter.
  874         (c) The practice of medicine as a resident or intern
  875  without holding a valid current registration pursuant to s.
  876  459.021.
  877         (d) Knowingly prescribing or dispensing, or causing to be
  878  prescribed or dispensed, controlled substances in a
  879  nonregistered pain-management clinic that is required to be
  880  registered with the Department of Health pursuant to s.
  881  459.0137(1).
  882         Section 10. Paragraphs (qq) and (rr) are added to
  883  subsection (1) of section 459.015, Florida Statutes, to read:
  884         459.015 Grounds for disciplinary action; action by the
  885  board and department.—
  886         (1) The following acts constitute grounds for denial of a
  887  license or disciplinary action, as specified in s. 456.072(2):
  888         (qq) Applicable to a licensee who serves as the designated
  889  physician of a pain-management clinic as defined in s. 458.3265
  890  or s. 459.0137:
  891         1.Registering a pain-management clinic through
  892  misrepresentation or fraud;
  893         2.Procuring, or attempting to procure, the registration of
  894  a pain-management clinic for any other person by making or
  895  causing to be made, any false representation;
  896         3.Failing to comply with any requirement of chapter 499,
  897  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  898  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  899  the Drug Abuse Prevention and Control Act; or chapter 893, the
  900  Florida Comprehensive Drug Abuse Prevention and Control Act;
  901         4.Being convicted or found guilty of, regardless of
  902  adjudication to, a felony or any other crime involving moral
  903  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  904  the courts of this state, of any other state, or of the United
  905  States;
  906         5.Being convicted of, or disciplined by a regulatory
  907  agency of the Federal Government or a regulatory agency of
  908  another state for any offense that would constitute a violation
  909  of this chapter;
  910         6.Being convicted of, or entering a plea of guilty or nolo
  911  contendere to, regardless of adjudication, a crime in any
  912  jurisdiction of the courts of this state, of any other state, or
  913  of the United States which relates to the practice of, or the
  914  ability to practice, a licensed health care profession;
  915         7.Being convicted of, or entering a plea of guilty or nolo
  916  contendere to, regardless of adjudication, a crime in any
  917  jurisdiction of the courts of this state, of any other state, or
  918  of the United States which relates to health care fraud;
  919         8.Dispensing any medicinal drug based upon a communication
  920  that purports to be a prescription as defined in s. 465.003(14)
  921  or s. 893.02 if the dispensing practitioner knows or has reason
  922  to believe that the purported prescription is not based upon a
  923  valid practitioner-patient relationship; or
  924         9.Failing to timely notify the board of the date of his or
  925  her termination from a pain-management clinic as required by s.
  926  459.0137(2).
  927         (rr)Failing to timely notify the department of the theft
  928  of prescription blanks from a pain-management clinic or a breach
  929  of other methods for prescribing within 24 hours as required by
  930  s. 459.0137(2).
  931         Section 11. Paragraph (j) is added to subsection (1),
  932  paragraph (d) is added to subsection (2), and paragraph (f) is
  933  added to subsection (7) of section 893.055, Florida Statutes, to
  934  read:
  935         893.055 Prescription drug monitoring program.—
  936         (1) As used in this section, the term:
  937         (j) “Program manager” means an employee of or a person
  938  contracted by the Department of Health who is designated to
  939  ensure the integrity of the prescription drug monitoring program
  940  in accordance with the requirements established in paragraphs
  941  (2)(a) and (b).
  942         (2)
  943         (d) The program manager shall work with professional health
  944  care licensure boards and the stakeholders listed in paragraph
  945  (b) to develop rules appropriate for identifying indicators of
  946  controlled substance abuse.
  947         (7)
  948         (f) The program manager, upon determining a pattern
  949  consistent with the rules established under paragraph (2)(c) and
  950  having cause to believe a violation of s. 893.13(7)(a)8.,
  951  (8)(a), or (8)(b) has occurred, may provide relevant information
  952  to the applicable law enforcement agency.
  953         Section 12. Subsections (4), (5), and (6) of section
  954  893.0551, Florida Statutes, are renumbered as subsections (5),
  955  (6), and (7), respectively, and subsection (4) is added to that
  956  section, to read:
  957         893.0551 Public records exemption for the prescription drug
  958  monitoring program.—
  959         (4) The department shall disclose such confidential and
  960  exempt information to the applicable law enforcement agency in
  961  accordance with s. 893.055(7)(b)2. The law enforcement agency
  962  may disclose the confidential and exempt information received
  963  from the department to a criminal justice agency as defined in
  964  s. 119.011 as part of an active investigation that is specific
  965  to a violation of s. 893.13(7)(a)8., s. 893.13(8)(a), or s.
  966  893.13(8)(b).
  967         Section 13. This act shall take effect October 1, 2010.

Site Map
Session:   Bills ·   Calendars ·   Bound Journals ·   Citator ·   Search ·   Appropriations ·   Redistricting ·   Bill Information Reports
Committee Publications
Historical Information
Statutes:   Introduction ·   View Statutes ·   Search Statutes
Flsenate.gov
Disclaimer: The information on this system is unverified. The journals or printed bills of the respective chambers should be consulted for official purposes.    Copyright © 2000-2019 State of Florida.     Privacy Statement     Contact Us     Get Acrobat Reader