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       Florida Senate - 2010                             CS for SB 2722
       
       
       
       By the Committee on Health Regulation; and Senators Gardiner,
       Aronberg, and Gelber
       
       
       
       588-03762-10                                          20102722c1
    1                        A bill to be entitled                      
    2         An act relating to pain management; amending s.
    3         456.037, F.S.; providing that pain-management clinics
    4         are business establishments that are required to be
    5         registered with the Department of Health; 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; amending s. 456.071,
   14         F.S.; providing for venue of judicial challenges to
   15         any subpoena or order issued by the Department of
   16         Health during its investigations; repealing s.
   17         458.309(5), (6), and (7), F.S., relating to pain
   18         management clinics; creating s. 458.3265, F.S.;
   19         requiring all privately owned pain-management clinics,
   20         or offices that primarily engage in the treatment of
   21         pain by prescribing or dispensing controlled substance
   22         medications or by employing a physician who is
   23         primarily engaged in the treatment of pain by
   24         prescribing or dispensing controlled substance
   25         medications, to register with the Department of Health
   26         by a specified date; providing exceptions; requiring
   27         each location of a pain-management clinic to register
   28         separately; requiring a clinic to designate a
   29         physician who is responsible for complying with
   30         requirements related to registration of the clinic;
   31         requiring the department to deny registration or
   32         revoke the registration of a pain-management clinic
   33         for certain conditions; authorizing the department to
   34         revoke a clinic’s certificate of registration and
   35         prohibit physicians associated with the clinic from
   36         practicing at the clinic’s office location; requiring
   37         a pain-management clinic to cease operating if its
   38         registration certificate is revoked or suspended;
   39         requiring certain named persons to remove all signs
   40         and symbols identifying the premises as a pain
   41         management clinic; requiring a pain-management clinic
   42         that has had its registration revoked or suspended to
   43         advise the department of the disposition of the
   44         medicinal drugs located on the premises; providing
   45         that medicinal drugs that are purchased or held by a
   46         pain–management clinic that is not registered may be
   47         deemed adulterated; prohibiting any person acting as
   48         an individual or as part of a group from applying for
   49         a certificate to operate a pain-management clinic for
   50         a certain period after the date the person’s
   51         registration certificate is revoked; providing that a
   52         change of ownership of a registered pain-management
   53         clinic requires submission of a new registration
   54         application; providing the responsibilities of a
   55         physician who provides professional services at a
   56         pain-management clinic; prohibiting certain
   57         practitioners from dispensing a specified dosage of
   58         certain controlled substances to patients who pay by
   59         cash, check, or credit card; providing an exception;
   60         providing a criminal penalty; providing for
   61         nonapplication; requiring the department to inspect
   62         pain-management clinics and its patient records;
   63         requiring the department and the Board of Medicine to
   64         adopt rules; authorizing the department to impose
   65         fines, deny a clinic’s registration, or revoke a
   66         clinic’s registration; amending s. 458.327, F.S.;
   67         providing that the commission of certain specified
   68         acts involving a nonregistered pain-management clinic
   69         constitutes a felony of the third degree or a
   70         misdemeanor of the first degree; amending s. 458.331,
   71         F.S.; providing additional acts that constitute
   72         grounds for disciplinary actions against health
   73         professional licensees; repealing s. 459.005(3), (4),
   74         and (5), F.S., relating to pain-management clinics;
   75         creating s. 459.0137, F.S.; requiring all privately
   76         owned pain-management clinics, or offices that
   77         primarily engage in the treatment of pain by
   78         prescribing or dispensing controlled substance
   79         medications or by employing an osteopathic physician
   80         who is primarily engaged in the treatment of pain by
   81         prescribing or dispensing controlled substance
   82         medications, to register with the department by a
   83         specified date; providing exceptions; requiring each
   84         location of a pain-management clinic to register
   85         separately; requiring a clinic to designate an
   86         osteopathic physician who is responsible for complying
   87         with requirements related to registration of the
   88         clinic; requiring the department to deny registration
   89         or revoke the registration of a pain-management clinic
   90         for certain conditions; authorizing the department to
   91         revoke a clinic’s certificate of registration and
   92         prohibit osteopathic physicians associated with the
   93         clinic from practicing at the clinic’s office
   94         location; requiring a pain-management clinic to cease
   95         operating if its registration certificate is revoked
   96         or suspended; requiring certain named persons to
   97         remove all signs and symbols identifying the premises
   98         as a pain-management clinic; requiring a pain
   99         management clinic that has had its registration
  100         revoked or suspended to advise the department of the
  101         disposition of the medicinal drugs located on the
  102         premises; providing that medicinal drugs that are
  103         purchased or held by a pain–management clinic that is
  104         not registered may be deemed adulterated; prohibiting
  105         any person acting as an individual or as part of a
  106         group from applying for a certificate to operate a
  107         pain-management clinic for a certain period after the
  108         date the person’s registration certificate is revoked;
  109         providing that a change of ownership of a registered
  110         pain-management clinic requires submission of a new
  111         registration application; providing the
  112         responsibilities of an osteopathic physician who
  113         provides professional services at a pain-management
  114         clinic; prohibiting certain practitioners from
  115         dispensing a specified dosage of certain controlled
  116         substances to patients who pay by cash, check, or
  117         credit card; providing an exception; providing a
  118         criminal penalty; providing for nonapplication;
  119         requiring the department to inspect pain-management
  120         clinics and its patient records; requiring the
  121         department and the Board of Osteopathic Medicine to
  122         adopt rules; authorizing the department to impose
  123         fines, deny a clinic’s registration, or revoke a
  124         clinic’s registration; amending s. 459.013, F.S.;
  125         providing that the commission of certain specified
  126         acts involving a nonregistered pain-management clinic
  127         constitutes a felony of the third degree or a
  128         misdemeanor of the first degree; amending s. 459.015,
  129         F.S.; providing additional acts that constitute
  130         grounds for disciplinary actions against health
  131         professional licensees; 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. Section 456.071, Florida Statutes, is amended to
  216  read:
  217         456.071 Power to administer oaths, take depositions, and
  218  issue subpoenas.—For the purpose of any investigation or
  219  proceeding conducted by the department, the department shall
  220  have the power to administer oaths, take depositions, make
  221  inspections when authorized by statute, issue subpoenas which
  222  shall be supported by affidavit, serve subpoenas and other
  223  process, and compel the attendance of witnesses and the
  224  production of books, papers, documents, and other evidence. The
  225  department shall exercise this power on its own initiative or
  226  whenever requested by a board or the probable cause panel of any
  227  board. Challenges to, and enforcement of, the subpoenas and
  228  orders shall be handled as provided in s. 120.569, except that
  229  venue is in the Circuit Court for the Second Judicial Circuit,
  230  in the county where the examination, investigation, or hearing
  231  is conducted, or in the county in which the person resides.
  232         Section 4. Subsections (4), (5), and (6) of section
  233  458.309, Florida Statutes, are repealed.
  234         Section 5. Section 458.3265, Florida Statutes, is created
  235  to read:
  236         458.3265Pain-management clinics.—
  237         (1)REGISTRATION.—
  238         (a) Effective January 4, 2010, all privately owned pain
  239  management clinics, facilities, or offices, hereinafter referred
  240  to as “clinics,” which advertise in any medium for any type of
  241  pain-management services, or employ a physician who is primarily
  242  engaged in the treatment of pain by prescribing or dispensing
  243  controlled substance medications, must register with the
  244  department unless:
  245         1. That clinic is licensed as a facility pursuant to
  246  chapter 395;
  247         2. The majority of the physicians who provide services in
  248  the clinic, facility, or office primarily provide surgical
  249  services;
  250         3. The clinic, facility, or office is owned by a publicly
  251  held corporation whose shares are traded on a national exchange
  252  or on the over-the-counter market and whose total assets at the
  253  end of corporation’s most recent fiscal quarter exceeded $50
  254  million;
  255         4. The clinic, facility, or office is affiliated with an
  256  accredited medical school at which training is provided for
  257  medical students, residents, or fellows;
  258         5. The clinic does not prescribe or dispense controlled
  259  substances for the treatment of pain; or
  260         6. The clinic, facility, or office is owned by a corporate
  261  entity exempt from federal taxation under 26 U.S.C. s.
  262  501(c)(3).
  263         (b) Each clinic location shall be registered separately
  264  regardless of whether the clinic is operated under the same
  265  business name or management as another clinic.
  266         (c) As a part of registration, a clinic must designate a
  267  physician who is responsible for complying with all requirements
  268  related to registration of the clinic. The designated physician
  269  shall have a full, active, and unencumbered license under this
  270  chapter or chapter 459 and shall practice at the office location
  271  for which the physician has assumed responsibility.
  272         (d)The department shall deny registration to any clinic
  273  not fully owned by a physician licensed under this chapter or
  274  chapter 459 or a group of physicians licensed under this chapter
  275  or chapter 459.
  276         (e) The department shall deny registration to any pain
  277  management clinic owned by or with any contractual or employment
  278  relationship with a physician:
  279         1. Whose Drug Enforcement Administration number has ever
  280  been revoked.
  281         2. Whose application for a license to prescribe, dispense,
  282  or administer a controlled substance has been denied by any
  283  jurisdiction.
  284         3. Who has been convicted of or plead guilty or nolo
  285  contender to, regardless of adjudication, an offense that
  286  constitutes a felony for receipt of illicit and diverted drugs,
  287  including a controlled substance listed in Schedule I, Schedule
  288  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  289  this state, any other state, or the United States.
  290         (f) If the department finds that a pain-management clinic
  291  is owned, directly or indirectly, by a person meeting any
  292  criteria listed in paragraph (d) or paragraph (e), the
  293  department shall revoke the certificate of registration
  294  previously issued by the department. As determined by rule, the
  295  department may grant an exemption to denying a registration or
  296  revoking a previously issued registration if more than 10 years
  297  have elapsed since adjudication. As used in this subsection, the
  298  term “convicted” includes an adjudication of guilt following a
  299  plea of guilty or nolo contendere or the forfeiture of a bond
  300  when charged with a crime.
  301         (g) The department may revoke the clinic’s certificate of
  302  registration and prohibit all physicians associated with that
  303  pain-management clinic from practicing at that office location
  304  based upon an annual inspection and evaluation of the factors
  305  described in subsection (3).
  306         (h)If the registration of a pain-management clinic is
  307  revoked or suspended, the designated physician of the pain
  308  management clinic, the owner or lessor of the pain-management
  309  clinic property, the manager, and the proprietor shall cease to
  310  operate the facility as a pain-management clinic as of the
  311  effective date of the suspension or revocation.
  312         (i)If a pain-management clinic registration is revoked or
  313  suspended, the designated physician of the pain-management
  314  clinic, the owner or lessor of the clinic property, the manager,
  315  or the proprietor is responsible for removing all signs and
  316  symbols identifying the premises as a pain-management clinic.
  317         (j)Upon the effective date of the suspension or
  318  revocation, the designated physician of the pain-management
  319  clinic shall advise the department of the disposition of the
  320  medicinal drugs located on the premises. The disposition is
  321  subject to the supervision and approval of the department.
  322  Medicinal drugs that are purchased or held by a pain–management
  323  clinic that is not registered may be deemed adulterated pursuant
  324  to s. 499.006.
  325         (k)If the clinic’s registration is revoked, any person
  326  named in the registration documents of the pain-management
  327  clinic, including persons owning or operating the pain
  328  management clinic, may not, as an individual or as a part of a
  329  group, apply to operate a pain-management clinic for 5 years
  330  after the date the registration is revoked.
  331         (l)The period of the suspension shall be prescribed by the
  332  department, but may not exceed 1 year.
  333         (m) A change of ownership of a registered pain-management
  334  clinic requires submission of a new registration application.
  335         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  336  apply to any physician who provides professional services in a
  337  pain-management clinic that is required to be registered in
  338  subsection (1).
  339         (a)A physician may not practice medicine in a pain
  340  management clinic, as described in subsection (4), if the pain
  341  management clinic is not registered with the department as
  342  required by this section. A physician who violates this
  343  paragraph is subject to review by his or her appropriate medical
  344  regulatory 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)After a physical examination of the patient, a
  350  physician, on the same day of dispensing or prescribing a
  351  controlled substance, must document in the patient’s record the
  352  reason for prescribing or dispensing more than a 72-hour dose of
  353  a controlled substance for the treatment of chronic nonmalignant
  354  pain.
  355         (d) A physician authorized to prescribe controlled
  356  substances who practices at a pain-management clinic is
  357  responsible for maintaining the control and security of his or
  358  her prescription blanks and any other method used for
  359  prescribing controlled substance pain medication. The physician
  360  shall comply with the requirements for counterfeit-resistant
  361  prescription blanks in s. 893.065 and the rules adopted pursuant
  362  to that section. The physician shall notify in writing the
  363  department within 24 hours following any theft or loss of a
  364  prescription blank or breach of any other method for prescribing
  365  pain medication.
  366         (e)The physician shall notify the applicable board in
  367  writing of the date of termination of employment within 10 days
  368  after terminating his or her employment with a pain-management
  369  clinic that is required to be registered under subsection (1).
  370         (f) A practitioner registered under s. 465.0276 who
  371  practices at a pain-management clinic that is required to be
  372  registered under this section or s. 459.0137, may not dispense
  373  more than a 72-hour supply of a controlled substance listed in
  374  Schedule II or Schedule III, as provided in s. 893.03, to
  375  patients who pay by cash, check, or credit card for such
  376  medications. This limitation does not apply to patients who have
  377  insurance coverage for the medications and are using cash,
  378  check, or a credit card to meet a required copayment or
  379  deductible. A practitioner who knowingly violates this paragraph
  380  commits a felony of the third degree, punishable as provided in
  381  s. 775.082, s. 775.083, or s. 775.084. This paragraph does not
  382  apply to practitioners who dispense medications to
  383  workers’compensation patients pursuant to chapter 440. This
  384  paragraph does not apply to the dispensing of complimentary
  385  packages of medicinal drugs to the practitioner’s own patients
  386  in the regular course of his or her practice without the payment
  387  of fee or remuneration of any kind, whether direct or indirect,
  388  and in conformity with the requirements of this subsection. This
  389  paragraph does not apply to controlled substances dispensed in
  390  the health care system of the Department of Corrections.
  391         (3) INSPECTION.—
  392         (a) The department shall inspect the clinic annually,
  393  including a review of the patient records, to ensure that it
  394  complies with this section and the rules of the Board of
  395  Medicine adopted pursuant to subsection (4) unless the office is
  396  accredited by a nationally recognized accrediting agency
  397  approved by the Board of Medicine.
  398         (b) During an onsite inspection, the department shall make
  399  a reasonable attempt to discuss each violation with the owner or
  400  designated physician of the pain-management clinic before
  401  issuing a formal written notification.
  402         (c) Any action taken to correct a violation shall be
  403  documented in writing by the owner or designated physician of
  404  the pain-management clinic and verified by followup visits by
  405  departmental personnel.
  406         (4) RULEMAKING.—
  407         (a) The department shall adopt rules necessary to
  408  administer the registration and inspection of pain-management
  409  clinics which establish the specific requirements, procedures,
  410  forms, and fees.
  411         (b) The department shall adopt a rule defining what
  412  constitutes practice by a designated physician at the office
  413  location for which the physician has assumed responsibility, as
  414  set forth in subsection (1). When adopting the rule, the
  415  department shall consider the number of clinic employees, the
  416  location of the pain-management clinic, its hours of operation,
  417  and the amount of controlled substances being prescribed,
  418  dispensed, or administered at the pain-management clinic.
  419         (c) The Board of Medicine a shall adopt a rule establishing
  420  the maximum number of prescriptions for Schedule II or Schedule
  421  III controlled substances which may be written at any one
  422  registered pain-management clinic during any 24-hour period.
  423         (d)The Board of Medicine shall adopt rules setting forth
  424  standards of practice for physicians practicing in privately
  425  owned pain-management clinics that primarily engage in the
  426  treatment of pain by prescribing or dispensing controlled
  427  substance medications. Such rules shall address, but need not be
  428  limited to:
  429         1.Facility operations;
  430         2.Physical operations;
  431         3.Infection control requirements;
  432         4.Health and safety requirements;
  433         5.Quality assurance requirements;
  434         6.Patient records;
  435         7.Training requirements for all facility health care
  436  practitioners who are not regulated by another board;
  437         8.Inspections; and
  438         9.Data collection and reporting requirements.
  439  
  440  A physician is primarily engaged in the treatment of pain by
  441  prescribing or dispensing controlled substance medications when
  442  the majority of the patients seen are prescribed or dispensed
  443  controlled substance medications for the treatment of chronic
  444  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  445  to cancer which persists beyond the usual course of the disease
  446  or the injury that is the cause of the pain or more than 90 days
  447  after surgery.
  448         (5) PENALTIES; ENFORCEMENT.—
  449         (a)The department may impose an administrative fine on the
  450  clinic of up to $5,000 per violation for violating the
  451  requirements of this section, chapter 499, the Florida Drug and
  452  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  453  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  454  Abuse Prevention and Control Act; chapter 893, the Florida
  455  Comprehensive Drug Abuse Prevention and Control Act; or the
  456  rules of the department. In determining whether a penalty is to
  457  be imposed, and in fixing the amount of the fine, the department
  458  shall consider the following factors:
  459         1. The gravity of the violation, including the probability
  460  that death or serious physical or emotional harm to a patient
  461  has resulted, or could have resulted, from the pain-management
  462  clinic’s actions, the severity of the action or potential harm,
  463  and the extent to which the provisions of the applicable laws or
  464  rules were violated.
  465         2. What actions, if any, the owner or designated physician
  466  took to correct the violations.
  467         3. Whether there were any previous violations at the pain
  468  management clinic.
  469         4. The financial benefits that the pain-management clinic
  470  derived from committing or continuing to commit the violation.
  471         (b) Each day a violation continues after the date fixed for
  472  termination as ordered by the department constitutes an
  473  additional, separate, and distinct violation.
  474         (c) The department may impose a fine and, in the case of an
  475  owner-operated pain-management clinic revoke or deny a clinic’s
  476  registration, if the clinic’s designated physician knowingly and
  477  intentionally misrepresents actions taken to correct a
  478  violation.
  479         (d) An owner or designated physician of a pain-management
  480  clinic who concurrently operates an unregistered pain-management
  481  clinic is subject to an administrative fine of $5,000 per day.
  482         (e) If the owner of a pain-management clinic fails to apply
  483  to register the clinic upon a change-of-ownership and operates
  484  the clinic under the new ownership, the owner is subject to a
  485  fine of $5,000.
  486         Section 6. Section 458.327, Florida Statutes, is amended to
  487  read:
  488         458.327 Penalty for violations.—
  489         (1) Each of the following acts constitutes a felony of the
  490  third degree, punishable as provided in s. 775.082, s. 775.083,
  491  or s. 775.084:
  492         (a) The practice of medicine or an attempt to practice
  493  medicine without a license to practice in Florida.
  494         (b) The use or attempted use of a license which is
  495  suspended or revoked to practice medicine.
  496         (c) Attempting to obtain or obtaining a license to practice
  497  medicine by knowing misrepresentation.
  498         (d) Attempting to obtain or obtaining a position as a
  499  medical practitioner or medical resident in a clinic or hospital
  500  through knowing misrepresentation of education, training, or
  501  experience.
  502         (e)Knowingly operating, owning, or managing a
  503  nonregistered pain-management clinic that is required to be
  504  registered with the Department of Health pursuant to s.
  505  458.3265(1).
  506         (2) Each of the following acts constitutes a misdemeanor of
  507  the first degree, punishable as provided in s. 775.082 or s.
  508  775.083:
  509         (a) Knowingly concealing information relating to violations
  510  of this chapter.
  511         (b) Making any willfully false oath or affirmation whenever
  512  an oath or affirmation is required by this chapter.
  513         (c) Referring any patient, for health care goods or
  514  services, to a partnership, firm, corporation, or other business
  515  entity in which the physician or the physician’s employer has an
  516  equity interest of 10 percent or more unless, prior to such
  517  referral, the physician notifies the patient of his or her
  518  financial interest and of the patient’s right to obtain such
  519  goods or services at the location of the patient’s choice. This
  520  section does not apply to the following types of equity
  521  interest:
  522         1. The ownership of registered securities issued by a
  523  publicly held corporation or the ownership of securities issued
  524  by a publicly held corporation, the shares of which are traded
  525  on a national exchange or the over-the-counter market;
  526         2. A physician’s own practice, whether he or she is a sole
  527  practitioner or part of a group, when the health care good or
  528  service is prescribed or provided solely for the physician’s own
  529  patients and is provided or performed by the physician or under
  530  the physician’s supervision; or
  531         3. An interest in real property resulting in a landlord
  532  tenant relationship between the physician and the entity in
  533  which the equity interest is held, unless the rent is
  534  determined, in whole or in part, by the business volume or
  535  profitability of the tenant or is otherwise unrelated to fair
  536  market value.
  537         (d) Leading the public to believe that one is licensed as a
  538  medical doctor, or is engaged in the licensed practice of
  539  medicine, without holding a valid, active license.
  540         (e) Practicing medicine or attempting to practice medicine
  541  with an inactive or delinquent license.
  542         (f) Knowingly prescribing or dispensing, or causing to be
  543  prescribed or dispensed, controlled substances in a
  544  nonregistered pain-management clinic that is required to be
  545  registered with the Department of Health pursuant to s.
  546  458.3265(1).
  547         Section 7. Paragraphs (oo), (pp), and (qq) are added to
  548  subsection (1) of section 458.331, Florida Statutes, to read:
  549         458.331 Grounds for disciplinary action; action by the
  550  board and department.—
  551         (1) The following acts constitute grounds for denial of a
  552  license or disciplinary action, as specified in s. 456.072(2):
  553         (oo) Applicable to a licensee who serves as the designated
  554  physician of a pain-management clinic as defined in s. 458.3265
  555  or s. 459.0137:
  556         1.Registering a pain-management clinic through
  557  misrepresentation or fraud;
  558         2.Procuring, or attempting to procure, the registration of
  559  a pain-management clinic for any other person by making or
  560  causing to be made, any false representation;
  561         3.Failing to comply with any requirement of chapter 499,
  562  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  563  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  564  the Drug Abuse Prevention and Control Act; or chapter 893, the
  565  Florida Comprehensive Drug Abuse Prevention and Control Act;
  566         4.Being convicted or found guilty of, regardless of
  567  adjudication to, a felony or any other crime involving moral
  568  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  569  the courts of this state, of any other state, or of the United
  570  States;
  571         5.Being convicted of, or disciplined by a regulatory
  572  agency of the Federal Government or a regulatory agency of
  573  another state for any offense that would constitute a violation
  574  of this chapter;
  575         6.Being convicted of, or entering a plea of guilty or nolo
  576  contendere to, regardless of adjudication, a crime in any
  577  jurisdiction which relates to the practice of, or the ability to
  578  practice, a licensed health care profession;
  579         7.Being convicted of, or entering a plea of guilty or nolo
  580  contendere to, regardless of adjudication, a crime in any
  581  jurisdiction which relates to health care fraud;
  582         8.Dispensing any medicinal drug based upon a communication
  583  that purports to be a prescription as defined in s. 465.003(14)
  584  or s. 893.02 if the dispensing practitioner knows or has reason
  585  to believe that the purported prescription is not based upon a
  586  valid practitioner-patient relationship; or
  587         9.Failing to have a licensed designated physician
  588  practicing at the location of the registered clinic. A violation
  589  of this paragraph may be the basis for a summary suspension as
  590  described in s. 456.073(8) or s. 120.60(6).
  591         (pp)Failing to timely notify the department of the theft
  592  of prescription blanks from a pain-management clinic or a breach
  593  of other methods for prescribing within 24 hours as required by
  594  s. 458.3265(2).
  595         (qq)Failing to timely notify the applicable board
  596  governing his or her prescribing privileges of the date of his
  597  or her termination from a pain-management clinic as required by
  598  s. 458.3265(2).
  599         Section 8. Subsections (3), (4), and (5) of section
  600  459.005, Florida Statutes, are repealed.
  601         Section 9. Section 459.0137, Florida Statutes, is created
  602  to read:
  603         459.0137Pain-management clinics.—
  604         (1)REGISTRATION.—
  605         (a) Effective January 4, 2010, all privately owned pain
  606  management clinics, facilities, or offices, hereinafter referred
  607  to as “clinics,” which advertise in any medium for any type of
  608  pain-management services, or employ an osteopathic physician who
  609  is primarily engaged in the treatment of pain by prescribing or
  610  dispensing controlled substance medications, must register with
  611  the department unless:
  612         1. That clinic is licensed as a facility pursuant to
  613  chapter 395;
  614         2. The majority of the physicians who provide services in
  615  the clinic, facility, or office primarily provide surgical
  616  services;
  617         3. The clinic, facility, or office is owned by a publicly
  618  held corporation whose shares are traded on a national exchange
  619  or on the over-the-counter market and whose total assets at the
  620  end of corporation’s most recent fiscal quarter exceeded $50
  621  million;
  622         4. The clinic, facility, or office is affiliated with an
  623  accredited medical school at which training is provided for
  624  medical students, residents, or fellows;
  625         5. The clinic does not prescribe or dispense controlled
  626  substances for the treatment of pain; or
  627         6. The clinic, facility, or office is owned by a corporate
  628  entity exempt from federal taxation under 26 U.S.C. s.
  629  501(c)(3).
  630         (b) Each clinic location shall be registered separately
  631  regardless of whether the clinic is operated under the same
  632  business name or management as another clinic.
  633         (c) As a part of registration, a clinic must designate an
  634  osteopathic physician who is responsible for complying with all
  635  requirements related to registration of the clinic. The
  636  designated physician shall have a full, active, and unencumbered
  637  license under chapter 458 or this chapter and shall practice at
  638  the office location for which the physician has assumed
  639  responsibility.
  640         (d)The department shall deny registration to any clinic
  641  not fully owned by a physician licensed under chapter 458 or
  642  this chapter or a group of physicians under to chapter 458 or
  643  this chapter.
  644         (e) The department shall deny registration to any pain
  645  management clinic owned by or with any contractual or employment
  646  relationship with a physician:
  647         1. Whose Drug Enforcement Administration number has ever
  648  been revoked.
  649         2. Whose application for a license to prescribe, dispense,
  650  or administer a controlled substance has been denied by any
  651  jurisdiction.
  652         3. Who has been convicted of or plead guilty or nolo
  653  contender to, regardless of adjudication, an offense that
  654  constitutes a felony for receipt of illicit and diverted drugs,
  655  including a controlled substance listed in Schedule I, Schedule
  656  II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
  657  this state, any other state, or the United States.
  658         (f) If the department finds that a pain-management clinic
  659  is owned, directly or indirectly, by a person meeting any
  660  criteria listed in paragraph (d) or paragraph (e), the
  661  department shall revoke the certificate of registration
  662  previously issued by the department. As determined by rule, the
  663  department may grant an exemption to denying a registration or
  664  revoking a previously issued registration if more than 10 years
  665  have elapsed since adjudication. As used in this subsection, the
  666  term “convicted” includes an adjudication of guilt following a
  667  plea of guilty or nolo contendere or the forfeiture of a bond
  668  when charged with a crime.
  669         (g) The department may revoke the clinic’s certificate of
  670  registration and prohibit all physicians associated with that
  671  pain-management clinic from practicing at that office location
  672  based upon an annual inspection and evaluation of the factors
  673  described in subsection (3).
  674         (h)If the registration of a pain-management clinic is
  675  revoked or suspended, the designated physician of the pain
  676  management clinic, the owner or lessor of the pain-management
  677  clinic property, the manager, and the proprietor shall cease to
  678  operate the facility as a pain-management clinic as of the
  679  effective date of the suspension or revocation.
  680         (i)If a pain-management clinic registration is revoked or
  681  suspended, the designated physician of the pain-management
  682  clinic, the owner or lessor of the clinic property, the manager,
  683  or the proprietor is responsible for removing all signs and
  684  symbols identifying the premises as a pain-management clinic.
  685         (j)Upon the effective date of the suspension or
  686  revocation, the designated physician of the pain-management
  687  clinic shall advise the department of the disposition of the
  688  medicinal drugs located on the premises. The disposition is
  689  subject to the supervision and approval of the department.
  690  Medicinal drugs that are purchased or held by a pain–management
  691  clinic that is not registered may be deemed adulterated pursuant
  692  to s. 499.006.
  693         (k)If the clinic’s registration is revoked, any person
  694  named in the registration documents of the pain-management
  695  clinic, including persons owning or operating the pain
  696  management clinic, may not as an individual or as a part of a
  697  group, make application for a permit to operate a pain
  698  management clinic for 5 years after the date the registration is
  699  revoked.
  700         (l)The period of the suspension shall be prescribed by the
  701  department, but may not exceed 1 year.
  702         (m) A change of ownership of a registered pain-management
  703  clinic requires submission of a new registration application.
  704         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  705  apply to any osteopathic physician who provides professional
  706  services in a pain-management clinic that is required to be
  707  registered in subsection (1).
  708         (a)An osteopathic physician may not practice medicine in a
  709  pain-management clinic, as described in subsection (4), if the
  710  pain-management clinic is not registered with the department as
  711  required by this section. An osteopathic physician who violates
  712  this paragraph is subject to review by his or her appropriate
  713  medical regulatory board.
  714         (b)A person may not dispense any medication, including a
  715  controlled substance, on the premises of a registered pain
  716  management clinic unless he or she is a physician licensed under
  717  this chapter or chapter 458.
  718         (c)After a physical examination of the patient, an
  719  osteopathic physician, on the same day of dispensing or
  720  prescribing a controlled substance, must document in the
  721  patient’s record the reason for prescribing or dispensing more
  722  than a 72-hour dose of a controlled substance for the treatment
  723  of chronic nonmalignant pain.
  724         (d) An osteopathic physician authorized to prescribe
  725  controlled substances who practices at a pain-management clinic
  726  is responsible for maintaining the control and security of his
  727  or her prescription blanks and any other method used for
  728  prescribing controlled substance pain medication. The
  729  osteopathic physician shall comply with the requirements for
  730  counterfeit-resistant prescription blanks in s. 893.065 and the
  731  rules adopted pursuant to that section. The osteopathic
  732  physician shall notify in writing the department within 24 hours
  733  following any theft or loss of a prescription blank or breach of
  734  any other method for prescribing pain medication.
  735         (e)The osteopathic physician shall notify the applicable
  736  board in writing of the date of termination of employment within
  737  10 days after terminating his or her employment with a pain
  738  management clinic that is required to be registered under
  739  subsection (1).
  740         (f) An osteopathic practitioner registered under s.
  741  465.0276 who practices at a pain-management clinic that is
  742  required to be registered under s. 458.3265 or this section may
  743  not dispense more than a 72-hour supply of a controlled
  744  substance listed in Schedule II or Schedule III, as provided in
  745  s. 893.03, to patients who pay by cash, check, or credit card
  746  for such medications. This limitation does not apply to patients
  747  who have insurance coverage for the medications and are using
  748  cash, check, or a credit card to meet a required copayment or
  749  deductible. A practitioner who knowingly violates this provision
  750  commits a felony of the third degree, punishable as provided in
  751  s. 775.082, s. 775.083, or s. 775.084. This paragraph does not
  752  apply to practitioners who dispense medications to
  753  workers’compensation patients pursuant to chapter 440. This
  754  paragraph does not apply to the dispensing of complimentary
  755  packages of medicinal drugs to the practitioner’s own patients
  756  in the regular course of his or her practice, without the
  757  payment of fee or remuneration of any kind, whether direct or
  758  indirect, and in conformity with the requirements of this
  759  subsection. This paragraph does not apply to controlled
  760  substances dispensed in the health care system of the Department
  761  of Corrections.
  762         (3) INSPECTION.—
  763         (a) The department shall inspect the clinic annually,
  764  including a review of the patient records, to ensure that it
  765  complies with this section and the rules of the Board of
  766  Osteopathic Medicine adopted pursuant to subsection (4) unless
  767  the office is accredited by a nationally recognized accrediting
  768  agency approved by the Board of Osteopathic Medicine.
  769         (b) During an onsite inspection, the department shall make
  770  a reasonable attempt to discuss each violation with the owner or
  771  designated physician of the pain-management clinic before
  772  issuing a formal written notification.
  773         (c) Any action taken to correct a violation shall be
  774  documented in writing by the owner or designated physician of
  775  the pain-management clinic and verified by followup visits by
  776  departmental personnel.
  777         (4) RULEMAKING.—
  778         (a) The department shall adopt rules necessary to
  779  administer the registration and inspection of pain-management
  780  clinics which establish the specific requirements, procedures,
  781  forms, and fees.
  782         (b) The department shall adopt a rule defining what
  783  constitutes practice by a designated physician at the office
  784  location for which the physician has assumed responsibility, as
  785  set forth in subsection (1). When adopting the rule, the
  786  department shall consider the number of clinic employees, the
  787  location of the pain-management clinic, its hours of operation,
  788  and the amount of controlled substances being prescribed,
  789  dispensed, or administered at the pain-management clinic.
  790         (c) The Board of Osteopathic Medicine a shall adopt a rule
  791  establishing the maximum number of prescriptions for Schedule II
  792  or Schedule III controlled substances which may be written at
  793  any one registered pain-management clinic during any 24-hour
  794  period.
  795         (d)The Board of Osteopathic Medicine shall adopt rules
  796  setting forth standards of practice for osteopathic physicians
  797  practicing in privately owned pain-management clinics that
  798  primarily engage in the treatment of pain by prescribing or
  799  dispensing controlled substance medications. Such rules shall
  800  address, but need not be limited to:
  801         1.Facility operations;
  802         2.Physical operations;
  803         3.Infection control requirements;
  804         4.Health and safety requirements;
  805         5.Quality assurance requirements;
  806         6.Patient records;
  807         7.Training requirements for all facility health care
  808  practitioners who are not regulated by another board;
  809         8.Inspections; and
  810         9.Data collection and reporting requirements.
  811  
  812  An osteopathic physician is primarily engaged in the treatment
  813  of pain by prescribing or dispensing controlled substance
  814  medications when the majority of the patients seen are
  815  prescribed or dispensed controlled substance medications for the
  816  treatment of chronic nonmalignant pain. Chronic nonmalignant
  817  pain is pain unrelated to cancer which persists beyond the usual
  818  course of the disease or the injury that is the cause of the
  819  pain or more than 90 days after surgery.
  820         (5) PENALTIES; ENFORCEMENT.—
  821         (a)The department may impose an administrative fine on the
  822  clinic of up to $5,000 per violation for violating the
  823  requirements of this section, chapter 499, the Florida Drug and
  824  Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
  825  Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
  826  Abuse Prevention and Control Act; chapter 893, the Florida
  827  Comprehensive Drug Abuse Prevention and Control Act; or the
  828  rules of the department. In determining whether a penalty is to
  829  be imposed, and in fixing the amount of the fine, the department
  830  shall consider the following factors:
  831         1. The gravity of the violation, including the probability
  832  that death or serious physical or emotional harm to a patient
  833  has resulted, or could have resulted, from the pain-management
  834  clinic’s actions, the severity of the action or potential harm,
  835  and the extent to which the provisions of the applicable laws or
  836  rules were violated.
  837         2. What actions, if any, the owner or designated physician
  838  took to correct the violations.
  839         3. Whether there were any previous violations at the pain
  840  management clinic.
  841         4. The financial benefits that the pain-management clinic
  842  derived from committing or continuing to commit the violation.
  843         (b) Each day a violation continues after the date fixed for
  844  termination as ordered by the department constitutes an
  845  additional, separate, and distinct violation.
  846         (c) The department may impose a fine and, in the case of an
  847  owner-operated pain-management clinic revoke or deny a clinic’s
  848  registration, if the clinic’s designated physician knowingly and
  849  intentionally misrepresents actions taken to correct a
  850  violation.
  851         (d) An owner or designated physician of a pain-management
  852  clinic who concurrently operates an unregistered pain-management
  853  clinic is subject to an administrative fine of $5,000 per day.
  854         (e) If the owner of a pain-management clinic fails to apply
  855  to register the clinic upon a change-of-ownership and operates
  856  the clinic under the new ownership, the owner is subject to a
  857  fine of $5,000.
  858         Section 10. Subsections (1) and (2) of section 459.013,
  859  Florida Statutes, are amended to read:
  860         459.013 Penalty for violations.—
  861         (1) Each of the following acts constitutes a felony of the
  862  third degree, punishable as provided in s. 775.082, s. 775.083,
  863  or s. 775.084:
  864         (a) The practice of osteopathic medicine, or an attempt to
  865  practice osteopathic medicine, without an active license or
  866  certificate issued pursuant to this chapter.
  867         (b) The practice of osteopathic medicine by a person
  868  holding a limited license, osteopathic faculty certificate, or
  869  other certificate issued under this chapter beyond the scope of
  870  practice authorized for such licensee or certificateholder.
  871         (c) Attempting to obtain or obtaining a license to practice
  872  osteopathic medicine by knowing misrepresentation.
  873         (d) Attempting to obtain or obtaining a position as an
  874  osteopathic medical practitioner or osteopathic medical resident
  875  in a clinic or hospital through knowing misrepresentation of
  876  education, training, or experience.
  877         (e)Knowingly operating, owning, or managing a
  878  nonregistered pain-management clinic that is required to be
  879  registered with the Department of Health pursuant to s.
  880  459.0137(1).
  881         (2) Each of the following acts constitutes a misdemeanor of
  882  the first degree, punishable as provided in s. 775.082 or s.
  883  775.083:
  884         (a) Knowingly concealing information relating to violations
  885  of this chapter.
  886         (b) Making any willfully false oath or affirmation whenever
  887  an oath or affirmation is required by this chapter.
  888         (c) The practice of medicine as a resident or intern
  889  without holding a valid current registration pursuant to s.
  890  459.021.
  891         (d) Knowingly prescribing or dispensing, or causing to be
  892  prescribed or dispensed, controlled substances in a
  893  nonregistered pain-management clinic that is required to be
  894  registered with the Department of Health pursuant to s.
  895  459.0137(1).
  896         Section 11. Paragraphs (qq), (rr), and (ss) are added to
  897  subsection (1) of section 459.015, Florida Statutes, to read:
  898         459.015 Grounds for disciplinary action; action by the
  899  board and department.—
  900         (1) The following acts constitute grounds for denial of a
  901  license or disciplinary action, as specified in s. 456.072(2):
  902         (qq) Applicable to a licensee who serves as the designated
  903  physician of a pain-management clinic as defined in s. 458.3265
  904  or s. 459.0137:
  905         1.Registering a pain-management clinic through
  906  misrepresentation or fraud;
  907         2.Procuring, or attempting to procure, the registration of
  908  a pain-management clinic for any other person by making or
  909  causing to be made, any false representation;
  910         3.Failing to comply with any requirement of chapter 499,
  911  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  912  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  913  the Drug Abuse Prevention and Control Act; or chapter 893, the
  914  Florida Comprehensive Drug Abuse Prevention and Control Act;
  915         4.Being convicted or found guilty of, regardless of
  916  adjudication to, a felony or any other crime involving moral
  917  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  918  the courts of this state, of any other state, or of the United
  919  States;
  920         5.Being convicted of, or disciplined by a regulatory
  921  agency of the Federal Government or a regulatory agency of
  922  another state for any offense that would constitute a violation
  923  of this chapter;
  924         6.Being convicted of, or entering a plea of guilty or nolo
  925  contendere to, regardless of adjudication, a crime in any
  926  jurisdiction which relates to the practice of, or the ability to
  927  practice, a licensed health care profession;
  928         7.Being convicted of, or entering a plea of guilty or nolo
  929  contendere to, regardless of adjudication, a crime in any
  930  jurisdiction which relates to health care fraud;
  931         8.Dispensing any medicinal drug based upon a communication
  932  that purports to be a prescription as defined in s. 465.003(14)
  933  or s. 893.02 if the dispensing practitioner knows or has reason
  934  to believe that the purported prescription is not based upon a
  935  valid practitioner-patient relationship; or
  936         9.Failing to have a licensed designated physician
  937  practicing at the location of the registered clinic. A violation
  938  of this paragraph may be the basis for a summary suspension as
  939  described in s. 456.073(8) or s. 120.60(6).
  940         (rr)Failing to timely notify the department of the theft
  941  of prescription blanks from a pain-management clinic or a breach
  942  of other methods for prescribing within 24 hours as required by
  943  s. 459.0137(2).
  944         (ss)Failing to timely notify the applicable board
  945  governing his or her prescribing privileges of the date of his
  946  or her termination from a pain-management clinic as required by
  947  s. 459.0137(2).
  948         Section 12. This act shall take effect October 1, 2010.

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