February 20, 2019
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       Florida Senate - 2010                                    SB 2272
       
       
       
       By Senator Fasano
       
       
       
       
       11-01256B-10                                          20102272__
    1                        A bill to be entitled                      
    2         An act relating to pain management; amending s.
    3         456.013, F.S.; requiring the Department of Health and
    4         applicable boards within the Department of Health to
    5         approve a mandatory continuing education course for
    6         any practitioner who prescribes, administers, or
    7         dispenses controlled substances that are listed in
    8         Schedule II, Schedule III, or Schedule IV of ch. 893,
    9         F.S.; requiring the training course to include certain
   10         specified topics; providing that completion of the
   11         course satisfies in part, the practitioner’s
   12         continuing education requirements; authorizing the
   13         department to exempt practitioners who have obtained
   14         specialty training in or related to pain management;
   15         providing dates of applicability for licensees and
   16         initial applicants for licenses; requiring the
   17         department to adopt rules to administer the training
   18         requirements; amending s. 456.037, F.S.; providing
   19         that pain-management clinics are business
   20         establishments subject to licensure by the Department
   21         of Health; requiring a health professional licensee
   22         who works at a pain-management clinic that prescribes
   23         controlled substances to be responsible for
   24         maintaining control and security over his or her blank
   25         prescription pads and any other method used to
   26         prescribe controlled substance pain medication;
   27         requiring the health professional licensee to notify
   28         the department within a specified time of the theft or
   29         loss of the blank prescription pads; requiring a
   30         health professional licensee to give written notice to
   31         the applicable board within a specified period after
   32         the health professional licensee’s termination of
   33         employment at the pain-management clinic; amending s.
   34         456.057, F.S.; providing that the Department of Health
   35         is not required to attempt to obtain authorization
   36         from a patient for the release of the patient’s
   37         medical records under certain circumstances; amending
   38         s. 456.069, F.S.; authorizing the Department of Health
   39         to inspect a pain-management clinic in a lawful manner
   40         at all reasonable hours for the purpose of determining
   41         if any provision of ch. 456, F.S., or any rule adopted
   42         by the department has been violated; amending s.
   43         456.071, F.S.; providing venue for judicial challenges
   44         to any subpoena or order issued by the Department of
   45         Health during its investigations; amending s. 456.072,
   46         F.S.; providing additional acts that constitute
   47         grounds for disciplinary actions against health
   48         professional licensees; amending s. 456.309, F.S.;
   49         requiring all privately owned pain-management clinics,
   50         or offices that primarily engage in the treatment of
   51         pain by prescribing or dispensing controlled substance
   52         medications or employ a physician who is primarily
   53         engaged in the treatment of pain by prescribing or
   54         dispensing controlled substance medications, to
   55         register with the Department of Health within a
   56         specified time; providing an exception; authorizing
   57         the department to deny an application for registering
   58         a pain-management clinic or to revoke or suspend the
   59         current registration certificate of a pain-management
   60         clinic for certain reasons; authorizing the department
   61         to impose fines for certain violations of law;
   62         requiring the department to consider certain factors
   63         when calculating the amount of the fine; providing
   64         that each day constitutes an additional fine;
   65         requiring the pain-management clinic to document in
   66         writing all efforts undertaken by the pain-management
   67         clinic to correct a violation; requiring a pain
   68         management clinic to cease operating if its
   69         registration certificate is revoked or suspended;
   70         requiring certain named persons to remove all signs
   71         and symbols identifying the premises as a pain
   72         management clinic; prohibiting any person acting as an
   73         individual or as part of a group from applying for a
   74         certificate to operate a pain-management clinic for a
   75         period of 5 years after the date the person’s
   76         registration certificate was revoked; providing for
   77         disposition of drugs at the former pain-management
   78         clinic; requiring the department to adopt rules;
   79         creating ss. 458.3265 and 459.0137, F.S.; providing
   80         for requirements for the registration of pain
   81         management clinics; prohibiting a physician or an
   82         osteopathic physician from practicing medicine in a
   83         pain-management clinic if the pain-management clinic
   84         is not registered with the Department of Health;
   85         requiring each location of a pain-management clinic to
   86         be registered separately regardless of whether the
   87         clinic is operated under the same business name or
   88         management as another clinic; prohibiting a pain
   89         management clinic from being owned by or having any
   90         contractual relationship with certain specified
   91         persons; providing that if the department finds that a
   92         privately owned pain-management clinic is owned by a
   93         person possessing disqualifying criteria, the
   94         department shall refuse to register the pain
   95         management clinic or revoke a previously issued
   96         certificate of registration; requiring the owner,
   97         operator, or designated physician to be responsible
   98         for the onsite management of a pain-management clinic;
   99         providing that an owner or operator who fails to
  100         comply with certain stated conditions commits a
  101         misdemeanor of the first degree; providing criminal
  102         penalties; providing that only certain designated
  103         persons may disperse medication; requiring a physician
  104         to document in the patient’s record why the physician
  105         is prescribing or dispensing more than a specified
  106         amount of a controlled substances for the treatment of
  107         chronic nonmalignant pain; defining terms; requiring,
  108         on or after a specified date, any person submitting an
  109         application for an initial or renewal registration
  110         certificate to operate a pain-management clinic to
  111         include certain specified information on the
  112         application form to the department; requiring the
  113         department to send to the Department of Law
  114         Enforcement fingerprints as a part of an applicant’s
  115         criminal history background check of registered
  116         persons for a statewide criminal record check, and to
  117         the Federal Bureau of Investigation for a national
  118         criminal history record check; requiring each person
  119         who applies for an initial or renewal registration to
  120         pay the department a fee for the cost of preparing and
  121         retaining the fingerprints and performing the ongoing
  122         searches of arrest records; requiring the State
  123         Surgeon General to order a pain-management clinic to
  124         cease operations if the owner or operator of the pain
  125         management clinic fails to pass a criminal history
  126         background check; providing an exemption; requiring
  127         the department and the Department of Law Enforcement
  128         to adopt rules; amending ss. 458.327 and 459.013,
  129         F.S.; providing that committing certain specified acts
  130         while managing a pain-management clinic constitutes a
  131         felony of the third degree or a misdemeanor of the
  132         first degree; amending s. 459.005, F.S.; authorizing
  133         the department to deny an application for registering
  134         a pain-management clinic, or to revoke or suspend the
  135         current registration for certain reasons; permitting
  136         the department to impose fines for certain violations
  137         of law; requiring the department to consider certain
  138         factors when calculating the amount of the fine;
  139         providing that each day constitutes an additional
  140         fine; requiring a pain-management clinic to cease
  141         operating as a pain-management clinic if its
  142         registration is revoked or suspended; requiring
  143         certain named persons to remove all signs and symbols
  144         identifying the premises as a pain-management clinic;
  145         prohibiting any person acting as an individual or as
  146         part of a group, make application for a permit to
  147         operate a pain-management clinic for a period of 5
  148         years after the date the registration was revoked;
  149         providing for disposition of drugs at the former pain
  150         management clinic; requiring the department to adopt
  151         certain rules; providing an effective date.
  152  
  153  Be It Enacted by the Legislature of the State of Florida:
  154  
  155         Section 1. Subsection (7) of section 456.013, Florida
  156  Statutes, is amended to read:
  157         456.013 Department; general licensing provisions.—
  158         (7)(a) The boards, or the department when there is no
  159  board, shall require the completion of a 2-hour course relating
  160  to prevention of medical errors as part of the licensure and
  161  renewal process. The 2-hour course shall count towards the total
  162  number of continuing education hours required for the
  163  profession. The course shall be approved by the board or
  164  department, as appropriate, and shall include a study of root
  165  cause analysis, error reduction and prevention, and patient
  166  safety. In addition, the course approved by the Board of
  167  Medicine and the Board of Osteopathic Medicine shall include
  168  information relating to the five most misdiagnosed conditions
  169  during the previous biennium, as determined by the board. If the
  170  course is being offered by a facility licensed pursuant to
  171  chapter 395 for its employees, the board may approve up to 1
  172  hour of the 2-hour course to be specifically related to error
  173  reduction and prevention methods used in that facility.
  174         (b)The boards, or the department if there is no board,
  175  shall require the completion of a 3-hour continuing education
  176  course relating to prescribing, administering, or dispensing
  177  controlled substances listed in Schedule II, Schedule III, or
  178  Schedule IV, as set forth in s. 893.03, as a condition for
  179  receiving an initial license or a license renewal. The course is
  180  required for any practitioner licensed pursuant to chapter 458,
  181  chapter 459, chapter 461, chapter 466, or chapter 457 who
  182  prescribes, administers, or dispenses controlled substances. The
  183  course must include, but need not be limited to:
  184         1.The goals of administering controlled substances to
  185  patients who require short-term and ongoing pain management;
  186         2.The guidelines and rules for prescribing controlled
  187  substances, including the use of a controlled substance
  188  agreement;
  189         3.The application of drug screening or drug testing to
  190  patients, including instruction on the usefulness and
  191  limitations of drug screening and drug testing;
  192         4.The role of controlled substances in treating short-term
  193  and ongoing pain syndromes, including instruction on the
  194  usefulness and limitations of controlled substance in treating
  195  pain;
  196         5.The use of evidenced-based, noncontrolled-substance
  197  pharmacological pain treatments on patients;
  198         6.The use of evidenced-based, nonpharmacological pain
  199  treatments on patients;
  200         7.The importance of properly obtaining a full medical
  201  history and completing a comprehensive physical examination of
  202  patients;
  203         8.The importance of keeping appropriate progress notes
  204  during the care of patients;
  205         9.The relationship of the co-occurring morbidities that
  206  occur with pain disorders, such as psychiatric and addictive
  207  disorders;
  208         10.The identification and prevention of drug abuse and
  209  drug diversion; and
  210         11.The laws and rules of this state which govern the
  211  prescription, administration, and distribution of controlled
  212  substances.
  213  
  214  The course hours must be included in the total number of hours
  215  of continuing education required by the profession and must be
  216  approved by the board, or by the department if there is no
  217  board. A course offered under the auspices of a facility
  218  licensed pursuant to chapter 395 for its employees must be
  219  approved by the board, or by the department if there is no
  220  board, if the course is at least 3 hours in duration and covers
  221  the topic of prescribing, administering, and dispensing
  222  controlled substances.
  223         (c)The boards may exempt a licensee from the training
  224  requirements set forth in paragraph (b) if the licensee has
  225  obtained specialty or subspecialty certification in or related
  226  to pain management from a specialty board recognized by the
  227  respective board.
  228         (d)The course requirements set forth in paragraph (b)
  229  apply to each licensee when renewing his or her license
  230  beginning on or after July 1, 2011, and to all applicants who
  231  are approved for licensure on or after January 1, 2012.
  232         (e)The boards, or the department if there is no board,
  233  shall adopt rules to administer this subsection by July 1, 2011.
  234         Section 2. Section 456.037, Florida Statutes, is amended to
  235  read:
  236         456.037 Business establishments; requirements for active
  237  status licenses; delinquency; discipline; applicability.—
  238         (1) A business establishment regulated by the Division of
  239  Medical Quality Assurance pursuant to this chapter may provide
  240  regulated services only if the business establishment has an
  241  active status license. A business establishment that provides
  242  regulated services without an active status license is in
  243  violation of this section and s. 456.072, and the board, or the
  244  department if there is no board, may impose discipline on the
  245  business establishment.
  246         (2) A business establishment must apply with a complete
  247  application, as defined by rule of the board, or the department
  248  if there is no board, to renew an active status license before
  249  the license expires. If a business establishment fails to renew
  250  before the license expires, the license becomes delinquent,
  251  except as otherwise provided in statute, in the license cycle
  252  following expiration.
  253         (3) A delinquent business establishment must apply with a
  254  complete application, as defined by rule of the board, or the
  255  department if there is no board, for active status within 6
  256  months after becoming delinquent. Failure of a delinquent
  257  business establishment to renew the license within the 6 months
  258  after the expiration date of the license renders the license
  259  null without any further action by the board or the department.
  260  Any subsequent licensure shall be as a result of applying for
  261  and meeting all requirements imposed on a business establishment
  262  for new licensure.
  263         (4) The status or a change in status of a business
  264  establishment license does not alter in any way the right of the
  265  board, or of the department if there is no board, to impose
  266  discipline or to enforce discipline previously imposed on a
  267  business establishment for acts or omissions committed by the
  268  business establishment while holding a license, whether active
  269  or null.
  270         (5) This section applies to any business establishment
  271  registered, permitted, or licensed by the department to do
  272  business. Business establishments include, but are not limited
  273  to, dental laboratories, electrology facilities, massage
  274  establishments, and pharmacies, and pain-management clinics
  275  required to be registered under s. 458.309 or s. 459.005.
  276         (6)A licensee authorized to prescribe controlled
  277  substances who practices at a pain-management clinic is
  278  responsible for maintaining the control and security of his or
  279  her prescription blanks and any other method used for
  280  prescribing controlled substance pain medication. The licensee
  281  shall comply with the requirements for counterfeit-resistant
  282  prescription blanks in s. 893.065 and the rules adopted pursuant
  283  to that section. The licensee shall notify in writing:
  284         (a) The department within 24 hours following any theft or
  285  loss of a prescription blank or breach of any other method for
  286  prescribing pain medication.
  287         (b)The applicable board of the date of termination of
  288  employment within 10 days after terminating his or her
  289  employment with a pain-management clinic.
  290         Section 3. Paragraph (a) of subsection (9) of section
  291  456.057, Florida Statutes, is amended to read:
  292         456.057 Ownership and control of patient records; report or
  293  copies of records to be furnished.—
  294         (9)(a)1. The department may obtain patient records pursuant
  295  to a subpoena without written authorization from the patient if
  296  the department and the probable cause panel of the appropriate
  297  board, if any, find reasonable cause to believe that a health
  298  care practitioner has excessively or inappropriately prescribed
  299  any controlled substance specified in chapter 893 in violation
  300  of this chapter or any professional practice act or that a
  301  health care practitioner has practiced his or her profession
  302  below that level of care, skill, and treatment required as
  303  defined by this chapter or any professional practice act and
  304  also find that appropriate, reasonable attempts were made to
  305  obtain a patient release. Notwithstanding the foregoing, the
  306  department need not attempt to obtain a patient release when
  307  investigating an offense involving the inappropriate
  308  prescribing, overprescribing, or diversion of controlled
  309  substances and the offense involves a pain-management clinic.
  310         2. The department may obtain patient records and insurance
  311  information pursuant to a subpoena without written authorization
  312  from the patient if the department and the probable cause panel
  313  of the appropriate board, if any, find reasonable cause to
  314  believe that a health care practitioner has provided inadequate
  315  medical care based on termination of insurance and also find
  316  that appropriate, reasonable attempts were made to obtain a
  317  patient release.
  318         3. The department may obtain patient records, billing
  319  records, insurance information, provider contracts, and all
  320  attachments thereto pursuant to a subpoena without written
  321  authorization from the patient if the department and probable
  322  cause panel of the appropriate board, if any, find reasonable
  323  cause to believe that a health care practitioner has submitted a
  324  claim, statement, or bill using a billing code that would result
  325  in payment greater in amount than would be paid using a billing
  326  code that accurately describes the services performed, requested
  327  payment for services that were not performed by that health care
  328  practitioner, used information derived from a written report of
  329  an automobile accident generated pursuant to chapter 316 to
  330  solicit or obtain patients personally or through an agent
  331  regardless of whether the information is derived directly from
  332  the report or a summary of that report or from another person,
  333  solicited patients fraudulently, received a kickback as defined
  334  in s. 456.054, violated the patient brokering provisions of s.
  335  817.505, or presented or caused to be presented a false or
  336  fraudulent insurance claim within the meaning of s.
  337  817.234(1)(a), and also find that, within the meaning of s.
  338  817.234(1)(a), patient authorization cannot be obtained because
  339  the patient cannot be located or is deceased, incapacitated, or
  340  suspected of being a participant in the fraud or scheme, and if
  341  the subpoena is issued for specific and relevant records.
  342         4. Notwithstanding subparagraphs 1.-3., when the department
  343  investigates a professional liability claim or undertakes action
  344  pursuant to s. 456.049 or s. 627.912, the department may obtain
  345  patient records pursuant to a subpoena without written
  346  authorization from the patient if the patient refuses to
  347  cooperate or if the department attempts to obtain a patient
  348  release and the failure to obtain the patient records would be
  349  detrimental to the investigation.
  350         Section 4. Section 456.069, Florida Statutes, is amended to
  351  read:
  352         456.069 Authority to inspect.—In addition to the authority
  353  specified in s. 465.017, duly authorized agents and employees of
  354  the department may shall have the power to inspect in a lawful
  355  manner at all reasonable hours:
  356         (1) Any pharmacy; or
  357         (2) Any establishment at which the services of a licensee
  358  authorized to prescribe controlled substances specified in
  359  chapter 893 are offered; or,
  360         (3) Any facility offering services that require the
  361  facility to be registered as a pain-management clinic pursuant
  362  to s. 458.309(4) or s. 459.005(3),
  363  
  364  for the purpose of determining if any of the provisions of this
  365  chapter or any practice act of a profession or any rule adopted
  366  thereunder is being violated; or for the purpose of securing
  367  such other evidence as may be needed for prosecution. Such
  368  evidence may include, but is not limited to, patient records.
  369  The department may obtain patient records without patient
  370  authorization or subpoena from any pain-management clinic
  371  required to be licensed if the department reasonably believes
  372  that obtaining such authorization is not feasible due to the
  373  volume of the dispensing and prescribing activity involving
  374  controlled substances or that obtaining patient authorization or
  375  the issuance of a subpoena would jeopardize the investigation.
  376         Section 5. Section 456.071, Florida Statutes, is amended to
  377  read:
  378         456.071 Power to administer oaths, take depositions, and
  379  issue subpoenas.—For the purpose of any investigation or
  380  proceeding conducted by the department, the department shall
  381  have the power to administer oaths, take depositions, make
  382  inspections when authorized by statute, issue subpoenas which
  383  shall be supported by affidavit, serve subpoenas and other
  384  process, and compel the attendance of witnesses and the
  385  production of books, papers, documents, and other evidence. The
  386  department shall exercise this power on its own initiative or
  387  whenever requested by a board or the probable cause panel of any
  388  board. Challenges to, and enforcement of, the subpoenas and
  389  orders shall be handled as provided in s. 120.569, except that
  390  venue is in the Circuit Court for the Second Judicial Circuit,
  391  in the county where the examination, investigation, or hearing
  392  is conducted, or in the county in which the person resides.
  393         Section 6. Paragraphs (mm), (nn), and (oo) are added to
  394  subsection (1) of section 456.072, Florida Statutes, to read:
  395         456.072 Grounds for discipline; penalties; enforcement.—
  396         (1) The following acts shall constitute grounds for which
  397  the disciplinary actions specified in subsection (2) may be
  398  taken:
  399         (mm)Applicable to a licensee who serves as the medical
  400  director or the designated physician of a pain-management clinic
  401  as defined in s. 458.305 or s. 459.005:
  402         1.Registering a pain-management clinic through
  403  misrepresentation or fraud or through an error of the department
  404  or board;
  405         2.Procuring, or attempting to procure, the registration of
  406  a pain-management clinic for any other person by making or
  407  causing to be made, any false representation;
  408         3.Failing to comply with any requirement of chapter 499,
  409  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  410  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  411  the Comprehensive Drug Abuse Prevention and Control Act; or
  412  chapter 893;
  413         4.Being convicted or found guilty of, regardless of
  414  adjudication to, a felony or any other crime involving moral
  415  turpitude fraud, dishonesty, or deceit in any jurisdiction of
  416  the courts of this state, of any other state, or of the United
  417  States;
  418         5.Being convicted of, or disciplined by a regulatory
  419  agency of the Federal Government or a regulatory agency of
  420  another state for, any offense that would constitute a violation
  421  of this chapter;
  422         6.Being convicted of, or entering a plea of guilty or nolo
  423  contendere to, regardless of adjudication, a crime in any
  424  jurisdiction which relates to the practice of, or the ability to
  425  practice, a licensed health care profession;
  426         7.Being convicted of, or entering a plea of guilty or nolo
  427  contendere to, regardless of adjudication, a crime in any
  428  jurisdiction which relates to health care fraud;
  429         8.Dispensing any medicinal drug based upon a communication
  430  that purports to be a prescription as defined in s. 465.003(14)
  431  or s. 893.02 if the dispensing practitioner knows or has reason
  432  to believe that the purported prescription is not based upon a
  433  valid practitioner-patient relationship; or
  434         9.Failing to have a licensed medical director employed or
  435  under contract with the clinic as required by chapter 400 or
  436  failing to have the licensed designated physician practicing at
  437  the location of the registered clinic.
  438  
  439  A violation of this paragraph may be the basis for a summary
  440  suspension as described in s. 456.073(8) or s. 120.60(6).
  441         (nn)Failing to timely notify the department of the theft
  442  of prescription blanks from a pain-management clinic or a breach
  443  of other methods for prescribing within 24 hours as required by
  444  s. 456.037(6).
  445         (oo)Failing to timely notify the applicable board
  446  governing his or her prescribing privileges of the date of his
  447  or her termination from a pain-management clinic as required by
  448  s. 456.037(6).
  449         Section 7. Section 458.309, Florida Statutes, is amended to
  450  read:
  451         458.309 Rulemaking authority.—
  452         (1) The board has authority to adopt rules pursuant to ss.
  453  120.536(1) and 120.54 to implement the provisions of this
  454  chapter conferring duties upon it.
  455         (2)(a) Any rules which the board adopts relating to the
  456  classroom phase of medical education shall not apply to any
  457  person who is enrolled in the classroom phase of medical
  458  education or has graduated prior to or at the time the rule
  459  becomes effective, so long as such person does not interrupt his
  460  or her medical education.
  461         (b)1. Any rules which the board adopts relating to the
  462  clinical clerkship phase of medical education shall not apply to
  463  any person who is enrolled in the clinical clerkship phase of
  464  medical education prior to or at the time the rule becomes
  465  effective, so long as such person does not interrupt his or her
  466  medical education.
  467         2. Rules adopted by the Florida Board of Medical Examiners
  468  prior to October 1, 1986, and relating to clinical clerkships
  469  for graduates of foreign medical schools do not apply to any
  470  such graduate who:
  471         a. Had completed a clinical clerkship prior to the
  472  effective date of the rule; or
  473         b. Had begun a clinical clerkship but had not completed the
  474  clinical clerkship prior to the effective date of the rule, so
  475  long as the clinical clerkship took no longer than 3 years to
  476  complete.
  477         (c) Any rules which the board adopts relating to residency
  478  shall not apply to any person who has begun his or her residency
  479  prior to or at the time the rule becomes effective, so long as
  480  such person does not interrupt the residency.
  481         (3) All physicians who perform level 2 procedures lasting
  482  more than 5 minutes and all level 3 surgical procedures in an
  483  office setting must register the office with the department
  484  unless that office is licensed as a facility pursuant to chapter
  485  395. The department shall inspect the physician’s office
  486  annually unless the office is accredited by a nationally
  487  recognized accrediting agency or an accrediting organization
  488  subsequently approved by the Board of Medicine. The actual costs
  489  for registration and inspection or accreditation shall be paid
  490  by the person seeking to register and operate the office setting
  491  in which office surgery is performed.
  492         (4) Effective January 4, 2010, all privately owned pain
  493  management clinics, facilities, or offices primarily engaged in
  494  the treatment of pain by prescribing or dispensing controlled
  495  substance medications, hereinafter referred to as “clinics,”
  496  which advertise in any medium for any type of pain-management
  497  services, or employ a physician who is primarily engaged in the
  498  treatment of pain by prescribing or dispensing controlled
  499  substance medications, must register with the department by
  500  January 4, 2010, unless that clinic is licensed as a facility
  501  pursuant to chapter 395. A physician may not practice medicine
  502  in a pain-management clinic that is required to but has not
  503  registered with the department. Each clinic location shall be
  504  registered separately regardless of whether the clinic is
  505  operated under the same business name or management as another
  506  clinic. If the clinic is licensed as a health care clinic under
  507  chapter 400, the medical director is responsible for registering
  508  the facility with the department. If the clinic is not
  509  registered pursuant to chapter 395 or chapter 400, the clinic
  510  shall, upon registration with the department, designate a
  511  physician who is responsible for complying with all requirements
  512  related to registration of the clinic. The designated physician
  513  shall have a full, active, and unencumbered license be licensed
  514  under this chapter or chapter 459 and shall practice at the
  515  office location for which the physician has assumed
  516  responsibility. The department shall inspect the clinic
  517  annually, including a review of patient records, to ensure that
  518  it complies with rules of the Board of Medicine adopted pursuant
  519  to this subsection and subsection (8) (5) unless the office is
  520  accredited by a nationally recognized accrediting agency
  521  approved by the Board of Medicine. The actual costs for
  522  registration and inspection or accreditation shall be paid by
  523  the physician seeking to register the clinic.
  524         (5)(a)The department may deny an application for
  525  registering a pain-management clinic or revoke or suspend a
  526  current registration. The department may impose an
  527  administrative fine on the clinic of up to $5,000 per violation
  528  for violating the requirements of this section, chapter 499, the
  529  Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  530  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  531  the Comprehensive Drug Abuse Prevention and Control Act; chapter
  532  893; or the rules of the department. In determining whether a
  533  penalty is to be imposed, and in fixing the amount of the fine,
  534  the department shall consider the following factors:
  535         1. The gravity of the violation, including the probability
  536  that death or serious physical or emotional harm to a patient
  537  has resulted, or could have resulted, from a licensee’s actions,
  538  the severity of the action or potential harm, and the extent to
  539  which the provisions of the applicable laws or rules were
  540  violated.
  541         2. What actions, if any, the owner, medical director, or
  542  designated physician took to correct the violations.
  543         3. Whether there were any previous violations at the pain
  544  management clinic.
  545         4. The financial benefits that the pain-management clinic
  546  derived from committing or continuing to commit the violation.
  547         (b) Each day a violation continues after the date fixed for
  548  termination as ordered by the department, constitutes an
  549  additional, separate, and distinct violation.
  550         (c) Any action taken to correct a violation shall be
  551  documented in writing by the owner, medical director, or
  552  designated physician of the pain-management clinic and verified
  553  by followup visits by departmental personnel. The department may
  554  impose a fine and, in the case of an owner-operated pain
  555  management clinic, revoke or deny a clinic’s license if the
  556  medical director of the pain-management clinic, or the clinic’s
  557  designated physician, knowingly and intentionally misrepresents
  558  actions taken to correct a violation.
  559         (d) An owner, medical director, or designated physician of
  560  a pain-management clinic who concurrently operates an unlicensed
  561  pain-management clinic is subject to an administrative fine of
  562  $5,000 per day.
  563         (e) Any pain-management clinic whose owner fails to apply
  564  for a change-of-ownership license and operates the clinic under
  565  the new ownership is subject to a fine of $5,000.
  566         (f) During an onsite inspection, the department shall make
  567  a reasonable attempt to discuss each violation with the owner,
  568  medical director, or designated physician of the pain-management
  569  clinic before issuing a formal written notification.
  570         (g)1.If the registration of a pain-management clinic is
  571  revoked or suspended, the designated physician or medical
  572  director of the pain-management clinic, the owner or lessor of
  573  the pain-management clinic property, and the owner, manager, or
  574  proprietor shall cease to operate the facility as a pain
  575  management clinic as of the effective date of the suspension or
  576  revocation.
  577         2.If a pain-management clinic registration is revoked or
  578  suspended, the designated physician or medical director of the
  579  pain-management clinic, the owner or lessor of the clinic
  580  property, or the owner, manager, or proprietor is responsible
  581  for removing all signs and symbols identifying the premises as a
  582  pain-management clinic.
  583         3.If the clinic’s registration is revoked, any person
  584  named in the registration documents of the pain-management
  585  clinic, including persons owning or operating the pain
  586  management clinic, may not as an individual or as a part of a
  587  group, make application for a permit to operate a pain
  588  management clinic for 5 years after the date the registration is
  589  revoked.
  590         4.Upon the effective date of the suspension or revocation,
  591  the pain-management clinic shall advise the department of the
  592  disposition of the medicinal drugs located on the premises. The
  593  disposition is subject to the supervision and approval of the
  594  department. Failure by a pain-management clinic to be registered
  595  as required by law is cause for all medicinal drugs purchased or
  596  held by the pain-management clinic to be adulterated pursuant to
  597  s. 499.006.
  598         5.The period of the suspension shall be prescribed by the
  599  department, but may not exceed 1 year.
  600         (6) The department shall adopt rules necessary to
  601  administer the registration and inspection of pain-management
  602  clinics establishing the specific requirements, procedures,
  603  forms, and fees.
  604         (7) The department shall adopt a rule defining what
  605  constitutes practice by a designated physician at the office
  606  location for which the physician has assumed responsibility, as
  607  set forth in subsections (3) and (4). When adopting the rule,
  608  the department shall consider the number of clinic employees,
  609  the location of the pain-management clinic, its hours of
  610  operation, and the amount of controlled substances being
  611  prescribed, dispensed, or administered at the pain-management
  612  clinic.
  613         (8)(5) The Board of Medicine shall adopt rules setting
  614  forth standards of practice for physicians practicing in
  615  privately owned pain-management clinics that primarily engage in
  616  the treatment of pain by prescribing or dispensing controlled
  617  substance medications. Such rules shall address, but need not be
  618  limited to, the following subjects:
  619         (a) Facility operations;
  620         (b) Physical operations;
  621         (c) Infection control requirements;
  622         (d) Health and safety requirements;
  623         (e) Quality assurance requirements;
  624         (f) Patient records;
  625         (g) Training requirements for all facility health care
  626  practitioners who are not regulated by another board;
  627         (h) Inspections; and
  628         (i) Data collection and reporting requirements.
  629  
  630  A physician is primarily engaged in the treatment of pain by
  631  prescribing or dispensing controlled substance medications when
  632  the majority of the patients seen are prescribed or dispensed
  633  controlled substance medications for the treatment of chronic
  634  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  635  to cancer which persists beyond the usual course of the disease
  636  or the injury that is the cause of the pain or more than 90 days
  637  after surgery.
  638         (9)(6) A privately owned clinic, facility, or office that
  639  advertises in any medium for any type of pain-management
  640  services or employs one or more physicians who are primarily
  641  engaged in the treatment of pain by prescribing or dispensing
  642  controlled substances is exempt from the registration provisions
  643  in subsection (4) if the majority of the physicians who provide
  644  services in the clinic, facility, or office primarily provide
  645  surgical services.
  646         Section 8. Section 458.3265, Florida Statutes, is created
  647  to read:
  648         458.3265Pain-management clinics.—
  649         (1)(a)A physician may not practice medicine in a pain
  650  management clinic, as described in s. 458.309(4), if the pain
  651  management clinic is not registered with the department as
  652  required by that section. As provided in s. 458.309(4), each
  653  location of a pain-management clinic must be registered
  654  separately regardless of whether the clinic is operated under
  655  the same business name or management as another clinic. If a
  656  pain-management clinic fails an annual inspection, the
  657  department may revoke the clinic’s certificate of registration
  658  and prohibit all physicians associated with that pain-management
  659  clinic from practicing at that office location. A physician who
  660  violates this paragraph is subject to review by his or her
  661  appropriate medical regulatory board.
  662         (b)A pain-management clinic may not be owned, in whole or
  663  in part, by or have any contractual relationship, whether
  664  through employment or by independent contract, with:
  665         1.A physician who during the course of his or her practice
  666  has been denied the privilege of prescribing, dispensing,
  667  administering, supplying, or selling any controlled substance or
  668  who has, during the course of his or her practice, had the board
  669  take disciplinary action in this state or any other state or by
  670  the United States, against his or her medical license as a
  671  result of violating laws or rules relating to prescribing or
  672  dispensing controlled substances or for his or her dependency on
  673  drugs or alcohol.
  674         2.A person whose application for a license to prescribe,
  675  dispense, or administer a controlled substance has been denied
  676  by any jurisdiction.
  677         3.The holder of a license issued by any jurisdiction which
  678  allowed the owner, employee, or person to prescribe, dispense,
  679  or administer a controlled substance and which has been
  680  restricted or revoked by the issuing jurisdiction.
  681         4.A person who is the subject of a disciplinary proceeding
  682  by any licensing entity for conduct resulting from
  683  inappropriately prescribing, dispensing, or administering a
  684  controlled substance.
  685         5.A person who has been convicted of or pled guilty or
  686  nolo contendere to, regardless of adjudication, an offense that
  687  constitutes a felony or a misdemeanor for receipt of illicit and
  688  diverted drugs, including a controlled substance listed in
  689  Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule
  690  V of s. 893.03, in this state, any other state, or the United
  691  States.
  692         (c)If the department finds that a privately owned pain
  693  management clinic is owned, directly or indirectly, by a person
  694  meeting any criteria listed in paragraph (b), the department
  695  shall refuse to register the pain-management clinic or shall
  696  revoke the certificate of registration previously issued by the
  697  department. As determined by rule, the department may grant an
  698  exemption if more than 10 years have elapsed since adjudication.
  699  As used in this subsection, the term “convicted” includes an
  700  adjudication of guilt following a plea of guilty or nolo
  701  contendere or the forfeiture of a bond when charged with a
  702  crime.
  703         (d)The owner, operator, or designated physician of a pain
  704  management clinic shall:
  705         1.Be onsite at the pain-management clinic for at least 33
  706  percent of the operating hours of the pain-management clinic,
  707  with exemptions provided by department rule. If this requirement
  708  is not met by a designated physician, the owner or operator
  709  shall be physically present at the pain-management clinic at
  710  least once a week to inspect the facility in accordance with
  711  department rule. Exemptions may be provided by department rule
  712  if the designated physician, owner, or operator is present
  713  weekly and conducts inspections; and
  714         2.Review on a weekly basis at least 33 percent of the
  715  total number of patient files of the clinic, including the
  716  patient files in the possession of a clinic employee or
  717  contractor to whom authority for patient care has been delegated
  718  by the pain-management clinic, with exemptions provided by
  719  department rule.
  720         (e)A violation of this subsection is grounds for
  721  disciplinary action against the clinic, its owner, its operator,
  722  or designated physician under s. 458.309. An owner or operator
  723  who fails to comply with this subsection commits a misdemeanor
  724  of the first degree, punishable as provided in s. 775.082 or s.
  725  775.083.
  726         (2)A person may not dispense any medication, including a
  727  controlled substance, on the premises of a pain-management
  728  clinic unless he or she is a physician licensed under this
  729  chapter or chapter 459; however, a pharmacist licensed under
  730  chapter 465 may dispense any medication, including a controlled
  731  substance, on the premises of a pain-management clinic.
  732         (3)After a physical examination of the patient the same
  733  day of dispensing a controlled substance, a physician must
  734  document in the patient’s record the reason for prescribing or
  735  dispensing more than a 72-hour dose of a controlled substance
  736  for the treatment of chronic nonmalignant pain. A physician
  737  shall follow the department’s rules for treating pain when
  738  prescribing the use of controlled substances and dispensing
  739  controlled substances. The failure to follow the department’s
  740  rules is grounds for disciplinary action by the Board of
  741  Medicine and the possible revocation of the clinic’s certificate
  742  of registration by the department.
  743         (4)As used in subsections (4) through (8), the term:
  744         (a)“Controlled substance” means a controlled substance
  745  listed in Schedule II, Schedule III, or Schedule IV of s.
  746  893.03.
  747         (b)“Parties affiliated with a pain-management clinic”
  748  means:
  749         1.A director, officer, trustee, partner, or committee
  750  member of a pain-management clinic or applicant, or a subsidiary
  751  or service corporation of the pain-management clinic or
  752  applicant; or
  753         2.A person who, directly or indirectly, manages, controls,
  754  or oversees the operation of a pain-management clinic or
  755  applicant, regardless of whether the person is a partner,
  756  shareholder, manager, member, officer, director, independent
  757  contractor, or employee of the pain-management clinic or
  758  applicant.
  759         (5)On or after January 3, 2011, an application for an
  760  initial or renewal registration of a pain-management clinic must
  761  include:
  762         (a)The name, full business address, and telephone number
  763  of the applicant.
  764         (b)All trade or business names used by the applicant.
  765         (c)The address, telephone numbers, and names of contact
  766  persons for each facility used by the applicant for the
  767  prescribing or dispensing of controlled substance medications in
  768  the treatment of pain.
  769         (d)The type of ownership or operation, such as a
  770  partnership, corporation, or sole proprietorship.
  771         (e)The names of each owner and each operator of the pain
  772  management clinic, including:
  773         1.If an individual, the name of the individual.
  774         2.If a partnership, the name of each partner and the name
  775  of the partnership.
  776         3.If a corporation:
  777         a.The name, address, and title of each corporate officer
  778  and director.
  779         b.The name and address of the corporation and the resident
  780  agent of the corporation, the resident agent’s address, and the
  781  corporation’s state of incorporation.
  782         c.The name and address of each shareholder of the
  783  corporation owning 5 percent or more of the outstanding stock of
  784  the corporation.
  785         4.If a sole proprietorship, the full name of the sole
  786  proprietor and the name of the business entity.
  787         5.If a limited liability company:
  788         a.The name and address of each member.
  789         b.The name and address of each manager.
  790         c.The name and address of the limited liability company,
  791  the resident agent of the limited liability company, and the
  792  name of the state in which the limited liability company was
  793  organized.
  794         (f)The tax year of the applicant.
  795         (g)A copy of the deed for the property on which the
  796  applicant’s pain-management clinic is located, if the clinic is
  797  owned by the applicant, or a copy of the applicant’s lease for
  798  the property on which the applicant’s pain-management clinic is
  799  located, which must have an original term of not less than 1
  800  calendar year, if the pain-management clinic is not owned by the
  801  applicant.
  802         (h)A list of all licenses and permits issued to the
  803  applicant by any other state which authorize the applicant to
  804  purchase or possess prescription drugs.
  805         (i)The name of the manager of the pain-management clinic
  806  that is applying for the initial or renewal registration, the
  807  next four highest ranking employees responsible for operations
  808  of the pain-management clinic, the name of all parties
  809  affiliated with the pain-management clinic, and the personal
  810  information statement and set of fingerprints required under
  811  subsection (6) for each person.
  812         (6)(a)Each person required by subsection (5) to provide a
  813  personal information statement and fingerprints shall provide
  814  the following information to the department on forms prescribed
  815  by the department:
  816         1.The person’s places of residence for the past 7 years.
  817         2.The person’s date and place of birth.
  818         3.The person’s occupations, positions of employment, and
  819  offices held during the past 7 years.
  820         4.The principal business and address of any business,
  821  corporation, or other organization in which the person:
  822         a.Held an office during the past 7 years; or
  823         b.Had an occupation or position of employment during the
  824  past 7 years.
  825         5.Whether the person has been, during the past 7 years,
  826  the subject of any proceeding for the revocation of any license
  827  and, if so, the nature of the proceeding and the disposition of
  828  the proceeding.
  829         6.Whether, during the past 7 years, the person has been
  830  enjoined, temporarily or permanently, by a court of competent
  831  jurisdiction from violating any federal or state law regulating
  832  the possession, control, or distribution of controlled
  833  substances, together with details concerning any such event.
  834         7.A description of any involvement by the person during
  835  the past 7 years, including any investments, other than the
  836  ownership of stock in a publicly traded company or mutual fund,
  837  with any business that manufactured, administered, prescribed,
  838  distributed, or stored pharmaceutical products and any lawsuits
  839  in which the businesses were named as a party.
  840         8.A description of any felony criminal offense of which
  841  the person, as an adult, was found guilty, regardless of whether
  842  adjudication of guilt was withheld or whether the person pled
  843  guilty or nolo contendere. A criminal offense committed in
  844  another jurisdiction which would have been a felony in this
  845  state must be reported. If the person indicates that a criminal
  846  conviction is under appeal and submits a copy of the notice of
  847  appeal of that criminal offense, the applicant shall, within 15
  848  days after the disposition of the appeal, submit to the
  849  department a copy of the final written order of disposition.
  850         9.A photograph of the person taken in the previous 30
  851  days.
  852         10.A set of fingerprints from the person on a form and
  853  under procedures specified by the department and payment of a
  854  fee equal to the cost incurred by the department for the
  855  criminal history record check of the person.
  856         11.The name, address, occupation, and date and place of
  857  birth for each member of the person’s immediate family who is 18
  858  years of age or older. As used in this subparagraph, the term
  859  “member of the person’s immediate family” includes the person’s
  860  spouse, children, parents, siblings, the spouses of the person’s
  861  children, and the spouses of the person’s siblings.
  862         12.Any other relevant information that the department
  863  requires.
  864         (b)The information required under paragraph (a) shall be
  865  provided under oath.
  866         (c)1.The department shall submit the fingerprints provided
  867  with an application for initial registration on or after January
  868  4, 2010, to the Department of Law Enforcement for a statewide
  869  criminal record check and for forwarding to the Federal Bureau
  870  of Investigation for a national criminal record check.
  871         2.For the renewal of a registration on or after January 3,
  872  2011, the department shall submit the fingerprints provided as a
  873  part of a renewal application and background check of registered
  874  persons to the Department of Law Enforcement for a statewide
  875  criminal record check, and for forwarding to the Federal Bureau
  876  of Investigation for a national criminal record check. For any
  877  subsequent renewal of a registration, the department shall
  878  submit the required information for a statewide and national
  879  criminal record check.
  880         3.Any person who submits to the department a set of
  881  fingerprints for a criminal record check is not required to
  882  provide a subsequent set of fingerprints for a criminal record
  883  check if the person has undergone a criminal record check with
  884  submission of fingerprints for background screening as a
  885  condition of the issuance of an initial registration or the
  886  initial renewal of a registration on or after January 4, 2010.
  887         4.The department shall submit fingerprints for those
  888  undergoing a background screening and they must be submitted
  889  electronically. The department shall screen background results
  890  to determine if an applicant meets registration requirements.
  891         5.The cost for the processing fingerprints for an initial
  892  or renewal registration must be borne by the person subject to
  893  the background check. The Department of Law Enforcement shall
  894  receive payment for processing the fingerprints submitted to it
  895  each month by invoice to the Department of Health or by credit
  896  card from the applicant or a vendor acting on behalf of the
  897  applicant.
  898         6.All fingerprints submitted to the Department of Law
  899  Enforcement shall be retained by the Department of Law
  900  Enforcement in a manner provided by rule and entered into the
  901  statewide automated fingerprint identification system authorized
  902  by s. 943.05(2)(b). The fingerprints shall thereafter be
  903  available for all purposes and uses authorized for arrest
  904  fingerprint cards entered in the statewide automated fingerprint
  905  identification system pursuant to s. 943.051.
  906         7.Fingerprints for arrests submitted or received under s.
  907  943.051 shall be searched against the fingerprints retained in
  908  the statewide automated fingerprint identification system. Any
  909  arrest record that is identified with the retained fingerprints
  910  of a person subject to the background screening under this
  911  section shall be reported to the department.
  912         8.Each person shall pay to the department a fee for the
  913  cost of retaining the fingerprints and performing the ongoing
  914  searches of arrest records. The Department of Law Enforcement
  915  shall receive payment for processing and retaining the
  916  fingerprints submitted to it each month by invoice to the
  917  Department of Health or by credit card from the applicant or a
  918  vendor acting on behalf of the applicant.
  919         9.The Department of Law Enforcement shall adopt rules
  920  establishing the amount of the fee and procedures for retaining
  921  the fingerprints, performing the searches, and disseminating the
  922  search results. The department shall notify the Department of
  923  Law Enforcement of any change in a person’s status as a person
  924  listed s. 458.3265 if, as a result of the change, the person’s
  925  fingerprints are no longer required to be retained under
  926  paragraph (a).
  927         (7)The State Surgeon General shall order a clinic closed
  928  for operations if closure is warranted following failure of the
  929  owner or operator of the pain-management clinic to pass a
  930  background check of his or her criminal history. As determined
  931  by rule, the department may grant an exemption if more than 10
  932  years have elapsed since adjudication.
  933         (8)By January 3, 2011, the department and the Department
  934  of Law Enforcement shall adopt rules pursuant to ss. 120.536(1)
  935  and 120.54 to administer the provisions of this section, which
  936  shall include, as necessary, the reporting, management,
  937  development, and implementation of the fingerprint requirements
  938  in this section.
  939         Section 9. Paragraph (e) is added to subsection (1) of
  940  section 458.327, Florida Statutes, and paragraph (f) is added to
  941  subsection (2) of that section, to read:
  942         458.327 Penalty for violations.—
  943         (1) Each of the following acts constitutes a felony of the
  944  third degree, punishable as provided in s. 775.082, s. 775.083,
  945  or s. 775.084:
  946         (e)Knowingly operating, owning, or managing a
  947  nonregistered pain-management clinic that is required to be
  948  registered with the Department of Health pursuant to s.
  949  458.309(4).
  950         (2) Each of the following acts constitutes a misdemeanor of
  951  the first degree, punishable as provided in s. 775.082 or s.
  952  775.083:
  953         (f)Knowingly prescribing or dispensing, or causing to be
  954  prescribed or dispensed, controlled substances in a
  955  nonregistered pain-management clinic that is required to be
  956  registered with the Department of Health pursuant to s.
  957  458.309(4).
  958         Section 10. Section 459.005, Florida Statutes, is amended
  959  to read:
  960         459.005 Rulemaking authority.—
  961         (1) The department and the board may has authority to adopt
  962  rules pursuant to ss. 120.536(1) and 120.54 to implement the
  963  provisions of this chapter conferring duties upon it.
  964         (2) All physicians who perform level 2 procedures lasting
  965  more than 5 minutes and all level 3 surgical procedures in an
  966  office setting must register the office with the department
  967  unless that office is licensed as a facility pursuant to chapter
  968  395. The department shall inspect the physician’s office
  969  annually unless the office is accredited by a nationally
  970  recognized accrediting agency or an accrediting organization
  971  subsequently approved by the Board of Osteopathic Medicine. The
  972  actual costs for registration and inspection or accreditation
  973  shall be paid by the person seeking to register and operate the
  974  office setting in which office surgery is performed.
  975         (3) Effective January 4, 2010, all privately owned pain
  976  management clinics, facilities, or offices, primarily engaged in
  977  the treatment of pain by prescribing or dispensing controlled
  978  substance medications, hereinafter referred to as “clinics,”
  979  which advertise in any medium for any type of pain-management
  980  services, or employ a physician who is licensed under this
  981  chapter and who is primarily engaged in the treatment of pain by
  982  prescribing or dispensing controlled substance medications, must
  983  register with the department by January 4, 2010, unless that
  984  clinic is licensed as a facility under chapter 395. A physician
  985  may not practice osteopathic medicine in a pain-management
  986  clinic that is required to but has not registered with the
  987  department. Each clinic location shall be registered separately
  988  regardless of whether the clinic is operated under the same
  989  business name or management as another clinic. If the clinic is
  990  licensed as a health care clinic under chapter 400, the medical
  991  director is responsible for registering the facility with the
  992  department. If the clinic is not registered under chapter 395 or
  993  chapter 400, the clinic shall, upon registration with the
  994  department, designate a physician who is responsible for
  995  complying with all requirements related to registration of the
  996  clinic. The designated physician shall have a full, active, and
  997  unencumbered license be licensed under chapter 458 or this
  998  chapter and shall practice at the office location for which the
  999  physician has assumed responsibility. The department shall
 1000  inspect the clinic annually to ensure that it complies with
 1001  rules of the Board of Osteopathic Medicine adopted pursuant to
 1002  this subsection and subsection (7)(4) unless the office is
 1003  accredited by a nationally recognized accrediting agency
 1004  approved by the Board of Osteopathic Medicine. The actual costs
 1005  for registration and inspection or accreditation shall be paid
 1006  by the physician seeking to register the clinic.
 1007         (4)(a)The department may deny an application for
 1008  registering a pain-management clinic or revoke or suspend a
 1009  current registration. The department may impose an
 1010  administrative fine on the clinic of up to $5,000 per violation
 1011  for violating the requirements of this section, chapter 499, the
 1012  Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
 1013  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
 1014  the Comprehensive Drug Abuse Prevention and Control Act; chapter
 1015  893; or the rules of the department. In determining whether a
 1016  penalty is to be imposed, and in fixing the amount of the fine,
 1017  the department shall consider the following factors:
 1018         1. The gravity of the violation, including the probability
 1019  that death or serious physical or emotional harm to a patient
 1020  has resulted, or could have resulted, from a licensee’s actions,
 1021  the severity of the action or potential harm, and the extent to
 1022  which the provisions of the applicable laws or rules were
 1023  violated.
 1024         2. What actions, if any, the owner, medical director, or
 1025  designated physician took to correct the violations.
 1026         3. Whether there were any previous violations at the pain
 1027  management clinic.
 1028         4. The financial benefits that the pain-management clinic
 1029  derived from committing or continuing to commit the violation.
 1030         (b) Each day a violation continues after the date fixed for
 1031  termination as ordered by the department, constitutes an
 1032  additional, separate, and distinct violation.
 1033         (c) Any action taken to correct a violation shall be
 1034  documented in writing by the owner, medical director, or
 1035  designated physician of the pain-management clinic and verified
 1036  by followup visits by department personnel. The department may
 1037  impose a fine and, in the case of an owner-operated pain
 1038  management clinic, revoke or deny a clinic’s license if the
 1039  medical director of the pain-management clinic, or the clinic’s
 1040  designated physician, knowingly and intentionally misrepresents
 1041  actions taken to correct a violation.
 1042         (d) An owner, medical director, or designated physician of
 1043  a pain-management clinic who concurrently operates an unlicensed
 1044  pain-management clinic is subject to an administrative fine of
 1045  $5,000 per day.
 1046         (e) Any pain-management clinic whose owner fails to apply
 1047  for a change-of-ownership license and operates the clinic under
 1048  the new ownership is subject to a fine of $5,000.
 1049         (f) During an onsite inspection, the department shall make
 1050  a reasonable attempt to discuss each violation with the owner,
 1051  medical director, or designated physician of the pain-management
 1052  clinic before issuing a formal written notification.
 1053         (g)1.If the registration of a pain-management clinic is
 1054  revoked or suspended, the designated physician or medical
 1055  director of the pain-management clinic, the owner or lessor of
 1056  the pain-management clinic property, and the owner, manager, or
 1057  proprietor shall cease to operate the facility as a pain
 1058  management clinic as of the effective date of the suspension or
 1059  revocation.
 1060         2.If a pain-management clinic registration is revoked or
 1061  suspended, the designated physician or medical director of the
 1062  pain-management clinic, the owner or lessor of the clinic
 1063  property, and the owner, manager, or proprietor are responsible
 1064  for removing all signs and symbols identifying the premises as a
 1065  pain-management clinic.
 1066         3.If the clinic’s registration is revoked, any person
 1067  named in the registration documents of the pain-management
 1068  clinic, including persons owning or operating the pain
 1069  management clinic, may not as an individual or as a part of a
 1070  group, make application for a permit to operate a pain
 1071  management clinic for 5 years after the date the registration is
 1072  revoked.
 1073         4.Upon the effective date of the suspension or revocation,
 1074  the pain-management clinic shall advise the department of the
 1075  disposition of the medicinal drugs located on the premises. The
 1076  disposition is subject to the supervision and approval of the
 1077  department. Failure by a pain-management clinic to be registered
 1078  as required by law is cause for all medicinal drugs purchased or
 1079  held by the pain-management clinic to be adulterated pursuant to
 1080  s. 499.006.
 1081         5.The period of the suspension shall be prescribed by the
 1082  department, but may not exceed 1 year.
 1083         (5) The department shall adopt rules necessary to
 1084  administer the registration and inspection of pain-management
 1085  clinics establishing the specific requirements, procedures,
 1086  forms, and fees.
 1087         (6) The department shall adopt a rule defining what
 1088  constitutes practice by a designated physician at the office
 1089  location for which the physician has assumed responsibility as
 1090  set forth in subsection (4). When adopting the rule, the
 1091  department shall consider the number of clinic employees, the
 1092  location of the pain-management clinic, its hours of operation,
 1093  and the amount of controlled substances being prescribed,
 1094  dispensed, or administered at the pain-management clinic.
 1095         (7)(4) The Board of Osteopathic Medicine shall adopt rules
 1096  setting forth standards of practice for physicians who practice
 1097  in privately owned pain-management clinics that primarily engage
 1098  in the treatment of pain by prescribing or dispensing controlled
 1099  substance medications. The Such rules shall address, but need
 1100  not be limited to, the following subjects:
 1101         (a) Facility operations;
 1102         (b) Physical operations;
 1103         (c) Infection control requirements;
 1104         (d) Health and safety requirements;
 1105         (e) Quality assurance requirements;
 1106         (f) Patient records;
 1107         (g) Training requirements for all facility health care
 1108  practitioners who are not regulated by another board;
 1109         (h) Inspections; and
 1110         (i) Data collection and reporting requirements.
 1111  
 1112  A physician is primarily engaged in the treatment of pain by
 1113  prescribing or dispensing controlled substance medications when
 1114  the majority of the patients seen are prescribed or dispensed
 1115  controlled substance medications for the treatment of chronic
 1116  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
 1117  to cancer which persists beyond the usual course of the disease
 1118  or the injury that is the cause of the pain or more than 90 days
 1119  after surgery.
 1120         (8)(5) A privately owned clinic, facility, or office that
 1121  advertises in any medium for any type of pain-management
 1122  services or employs one or more physicians who are primarily
 1123  engaged in the treatment of pain by prescribing or dispensing
 1124  controlled substances is exempt from the registration provisions
 1125  in subsection (3) if the majority of the physicians who provide
 1126  services in the clinic, facility, or office primarily provide
 1127  surgical services.
 1128         Section 11. Paragraph (e) is added to subsection (1) of
 1129  section 459.013, Florida Statutes, and paragraph (d) is added to
 1130  subsection (2) of that section, to read:
 1131         459.013 Penalty for violations.—
 1132         (1) Each of the following acts constitutes a felony of the
 1133  third degree, punishable as provided in s. 775.082, s. 775.083,
 1134  or s. 775.084:
 1135         (e)Knowingly operating, owning, or managing a
 1136  nonregistered pain-management clinic that is required to be
 1137  registered with the Department of Health pursuant to s.
 1138  459.005(3).
 1139         (2) Each of the following acts constitutes a misdemeanor of
 1140  the first degree, punishable as provided in s. 775.082 or s.
 1141  775.083:
 1142         (d) Knowingly prescribing, dispensing, or causing to be
 1143  prescribed or dispensed controlled substances in a nonregistered
 1144  pain-management clinic that is required to be registered with
 1145  the Department of Health pursuant to s. 459.005(3).
 1146         Section 12. Section 459.0137, Florida Statutes, is created
 1147  to read:
 1148         459.0137Pain-management clinics.—
 1149         (1)(a)An osteopathic physician may not practice
 1150  osteopathic medicine in a pain-management clinic that is not
 1151  registered with the department as required by s. 459.005(3) Each
 1152  location of a pain-management clinic must be registered
 1153  separately regardless of whether the clinic is operated under
 1154  the same business name or management as another clinic. If a
 1155  pain-management clinic fails an annual inspection pursuant to s.
 1156  459.005(3), the department may revoke the clinic’s certificate
 1157  of registration and prohibit all physicians associated with that
 1158  pain-management clinic from practicing at that office location.
 1159  A physician who violates this paragraph is subject to review by
 1160  his or her appropriate medical regulatory board.
 1161         (b)A pain-management clinic may not be owned, in whole or
 1162  in part, by or have any contractual relationship, whether
 1163  through employment or by independent contract, with:
 1164         1.An osteopathic physician who during the course of his or
 1165  her practice has been denied the privilege of prescribing,
 1166  dispensing, administering, supplying, or selling any controlled
 1167  substance and who has, during the course of his or her practice,
 1168  or had the board take disciplinary action in this state or any
 1169  other state or by the United States against his or her medical
 1170  license as a result of violating laws or rules relating to
 1171  prescribing or dispensing controlled substances or for his or
 1172  her dependency on drugs or alcohol.
 1173         2.A person whose application for a license to prescribe,
 1174  dispense, or administer a controlled substance has been denied
 1175  by any jurisdiction.
 1176         3.The holder of a license issued by any jurisdiction which
 1177  allowed the owner, employee, or person to prescribe, dispense,
 1178  or administer a controlled substance and which has been
 1179  restricted or revoked by the issuing jurisdiction.
 1180         4.A person who is the subject of a disciplinary proceeding
 1181  by any licensing entity for conduct resulting from
 1182  inappropriately prescribing, dispensing, or administering a
 1183  controlled substance.
 1184         5.A person who has been convicted of or pled guilty or
 1185  nolo contendere to, regardless of adjudication, an offense that
 1186  constitutes a felony or a misdemeanor for receiving illicit and
 1187  diverted drugs, including a controlled substance listed in
 1188  Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule
 1189  V of s. 893.03, in this state, any other state, or the United
 1190  States.
 1191         (c)If the department finds that a privately owned pain
 1192  management clinic is owned, directly or indirectly, by a person
 1193  meeting any criteria listed in paragraph (b), the department
 1194  shall refuse to register the pain-management clinic or shall
 1195  revoke the certificate of registration previously issued by the
 1196  department. As determined by rule, the department may grant an
 1197  exemption if more than 10 years have elapsed since adjudication.
 1198  As used in this subsection, the term “convicted” includes an
 1199  adjudication of guilt following a plea of guilty or nolo
 1200  contendere or the forfeiture of a bond when charged with a
 1201  crime.
 1202         (d)The owner, operator, or designated osteopathic
 1203  physician of a pain-management clinic shall:
 1204         1.Be onsite at the pain-management clinic for at least 33
 1205  percent of the operating hours of the pain-management clinic
 1206  with exemptions provided by department rule. If this requirement
 1207  is not met by a designated physician, the owner or operator
 1208  shall be physically present at the pain-management clinic at
 1209  least once a week to inspect the facility in accordance with
 1210  department rule. Exemptions may be provided by department rule
 1211  if the designated osteopathic physician is present weekly and
 1212  conducts inspections; and
 1213         2.Review on a weekly basis at least 33 percent of the
 1214  total number of patient files of the pain-management clinic,
 1215  including the patient files in the possession of a pain
 1216  management clinic employee or contractor to whom authority for
 1217  patient care has been delegated by the pain-management clinic,
 1218  with exemptions provided by department rule.
 1219         (e)A violation of this subsection is grounds for
 1220  disciplinary action against the pain-management clinic, its
 1221  owner, its operator or designated osteopathic physician under s.
 1222  459.005. An owner or operator who fails to comply with this
 1223  subsection commits a misdemeanor of the first degree, punishable
 1224  as provided in s. 775.082 or s. 775.083.
 1225         (2)A person may not dispense any medication, including a
 1226  controlled substance, on the premises of a pain-management
 1227  clinic unless he or she is a physician licensed under this
 1228  chapter or chapter 458; however, a pharmacist licensed under
 1229  chapter 465 may dispense any medication, including a controlled
 1230  substance, on the premises of a pain-management clinic.
 1231         (3)After a physical examination of the patient the same
 1232  day that a controlled substance is dispensed, a physician must
 1233  document in the patient’s record the reason for prescribing or
 1234  dispensing more than a 72-hour dose of a controlled substance
 1235  for the treatment of chronic nonmalignant pain. A physician
 1236  shall follow the department’s rules for treating pain when
 1237  prescribing the use of controlled substances and dispensing
 1238  controlled substances. The failure to follow the department’s
 1239  rules is grounds for disciplinary action by the Board of
 1240  Osteopathic Medicine and the possible revocation of the clinic’s
 1241  certificate of registration by the department.
 1242         (4)As used in this section, the term:
 1243         (a)“Controlled substance” means a controlled substance
 1244  listed in Schedule II, Schedule III, or Schedule IV of s.
 1245  893.03.
 1246         (b)“Parties affiliated with a pain-management clinic”
 1247  means:
 1248         1.A director, officer, trustee, partner, or committee
 1249  member of a pain-management clinic or applicant, or a subsidiary
 1250  or service corporation of the pain-management clinic or
 1251  applicant; or
 1252         2.A person who, directly or indirectly, manages, controls,
 1253  or oversees the operation of a pain-management clinic or
 1254  applicant, regardless of whether the person is a partner,
 1255  shareholder, manager, member, officer, director, independent
 1256  contractor, or employee of the pain-management clinic or
 1257  applicant.
 1258         (5)On or after January 3, 2011, an application for an
 1259  initial or renewal registration of a pain-management clinic must
 1260  include:
 1261         (a)The name, full business address, and telephone number
 1262  of the applicant.
 1263         (b)All trade or business names used by the applicant.
 1264         (c)The address, telephone numbers, and names of contact
 1265  persons for each facility used by the applicant for the
 1266  prescribing or dispensing of controlled substance medications in
 1267  the treatment of pain.
 1268         (d)The type of ownership or operation, such as a
 1269  partnership, corporation, or sole proprietorship.
 1270         (e)The names of each owner and each operator of the pain
 1271  management clinic, including:
 1272         1.If an individual, the name of the individual.
 1273         2.If a partnership, the name of each partner and the name
 1274  of the partnership.
 1275         3.If a corporation:
 1276         a.The name, address, and title of each corporate officer
 1277  and director.
 1278         b.The name and address of the corporation and the resident
 1279  agent of the corporation, the resident agent’s address, and the
 1280  corporation’s state of incorporation.
 1281         c.The name and address of each shareholder of the
 1282  corporation that owns 5 percent or more of the outstanding stock
 1283  of the corporation.
 1284         4.If a sole proprietorship, the full name of the sole
 1285  proprietor and the name of the business entity.
 1286         5.If a limited liability company:
 1287         a.The name and address of each member.
 1288         b.The name and address of each manager.
 1289         c.The name and address of the limited liability company,
 1290  the resident agent of the limited liability company, and the
 1291  name of the state in which the limited liability company was
 1292  organized.
 1293         (f)The tax year of the applicant.
 1294         (g)A copy of the deed for the property on which the
 1295  applicant’s pain-management clinic is located, if the clinic is
 1296  owned by the applicant, or a copy of the applicant’s lease for
 1297  the property on which the applicant’s pain-management clinic is
 1298  located, which must have an original term of not less than 1
 1299  calendar year, if the pain-management clinic is not owned by the
 1300  applicant.
 1301         (h)A list of all licenses and permits issued to the
 1302  applicant by any other state which authorize the applicant to
 1303  purchase or possess prescription drugs.
 1304         (i)The name of the manager of the pain-management clinic
 1305  that is applying for the initial or renewal registration, the
 1306  next four highest ranking employees responsible for operations
 1307  of the pain-management clinic, the name of all parties
 1308  affiliated with the pain-management clinic, and the personal
 1309  information statement and fingerprints required under subsection
 1310  (6) for each person.
 1311         (6)(a)Each person required by subsection (5) to provide a
 1312  personal information statement and fingerprints shall provide
 1313  the following information to the department on forms prescribed
 1314  by the department:
 1315         1.The person’s places of residence for the past 7 years.
 1316         2.The person’s date and place of birth.
 1317         3.The person’s occupations, positions of employment, and
 1318  offices held during the past 7 years.
 1319         4.The principal business and address of any business,
 1320  corporation, or other organization in which the person:
 1321         a.Held an office during the past 7 years; or
 1322         b.Had an occupation or position of employment during the
 1323  past 7 years.
 1324         5.Whether the person has been, during the past 7 years,
 1325  the subject of any proceeding for the revocation of any license
 1326  and, if so, the nature of the proceeding and the disposition of
 1327  the proceeding.
 1328         6.Whether, during the past 7 years, the person has been
 1329  enjoined, temporarily or permanently, by a court of competent
 1330  jurisdiction from violating any federal or state law regulating
 1331  the possession, control, or distribution of controlled
 1332  substances, together with details concerning any such event.
 1333         7.A description of any involvement by the person during
 1334  the past 7 years, including any investments, other than the
 1335  ownership of stock in a publicly traded company or mutual fund,
 1336  with any business that manufactured, administered, prescribed,
 1337  distributed, or stored pharmaceutical products and any lawsuits
 1338  in which the businesses were named as a party.
 1339         8.A description of any felony criminal offense of which
 1340  the person, as an adult, was found guilty, regardless of whether
 1341  adjudication of guilt was withheld or whether the person pled
 1342  guilty or nolo contendere. A criminal offense committed in
 1343  another jurisdiction which would have been a felony in this
 1344  state must be reported. If the person indicates that a criminal
 1345  conviction is under appeal and submits a copy of the notice of
 1346  appeal of that criminal offense, the applicant shall, within 15
 1347  days after the disposition of the appeal, submit to the
 1348  department a copy of the final written order of disposition.
 1349         9.A photograph of the person taken in the previous 30
 1350  days.
 1351         10.A set of fingerprints from the person on a form and
 1352  under procedures specified by the department and payment of a
 1353  fee equal to the cost incurred by the department for the
 1354  criminal history record check of the person.
 1355         11.The name, address, occupation, and date and place of
 1356  birth for each member of the person’s immediate family who is 18
 1357  years of age or older. As used in this subparagraph, the term
 1358  “member of the person’s immediate family” includes the person’s
 1359  spouse, children, parents, siblings, the spouses of the person’s
 1360  children, and the spouses of the person’s siblings.
 1361         12.Any other relevant information that the department
 1362  requires.
 1363         (b)The information required under paragraph (a) shall be
 1364  provided under oath.
 1365         (c)1.The department shall submit the fingerprints provided
 1366  with an application for initial registration to the Department
 1367  of Law Enforcement for a statewide criminal record check and for
 1368  forwarding to the Federal Bureau of Investigation for a national
 1369  criminal record check.
 1370         2.For the renewal of a registration on or after January 3,
 1371  2011, the department shall submit the fingerprints provided as a
 1372  part of a renewal application and background check of registered
 1373  persons to the Department of Law Enforcement for a statewide
 1374  criminal record check, and for forwarding to the Federal Bureau
 1375  of Investigation for a national criminal record check. For any
 1376  subsequent renewal of a registration, the department shall
 1377  submit the required information for a statewide and national
 1378  criminal record check.
 1379         3.Any person who submits to the department a set of
 1380  fingerprints for a criminal record check is not required to
 1381  provide a subsequent set of fingerprints for a criminal record
 1382  check if the person has undergone a criminal record check with
 1383  submission of fingerprints for background screening as a
 1384  condition of the issuance of an initial registration or the
 1385  renewal of a registration on or after January 4, 2011.
 1386         4.The department shall submit fingerprints for those
 1387  undergoing a background screening and they must be submitted
 1388  electronically.The department shall screen background results
 1389  to determine if an applicant meets registration requirements.
 1390         5.The cost for the processing fingerprints for an initial
 1391  or renewal registration must be borne by the person subject to
 1392  the background check. The Department of Law Enforcement shall
 1393  receive payment for processing the fingerprints submitted to it
 1394  each month by invoice to the Department of Health or by credit
 1395  card from the applicant or a vendor acting on behalf of the
 1396  applicant.
 1397         6.All fingerprints submitted to the Department of Law
 1398  Enforcement shall be retained by the Department of Law
 1399  Enforcement in a manner provided by rule and entered into the
 1400  statewide automated fingerprint identification system authorized
 1401  by s. 943.05(2)(b).The fingerprints shall thereafter be
 1402  available for all purposes and uses authorized for arrest
 1403  fingerprint cards entered in the statewide automated fingerprint
 1404  identification system pursuant to s. 943.051.
 1405         7.Fingerprints for arrests submitted or received under s.
 1406  943.051 shall be searched against the fingerprints retained in
 1407  the statewide automated fingerprint identification system. Any
 1408  arrest record that is identified with the retained fingerprints
 1409  of a person subject to the background screening under this
 1410  section shall be reported to the department.
 1411         8.Each person shall pay to the department a fee for the
 1412  cost of retaining the fingerprints and performing the ongoing
 1413  searches of arrest records. The Department of Law Enforcement
 1414  shall receive payment for processing and retaining the
 1415  fingerprints submitted to it each month by invoice to the
 1416  Department of Health or by credit card from the applicant or a
 1417  vendor acting on behalf of the applicant.
 1418         9.The Department of Law Enforcement shall adopt rules
 1419  establishing the amount of the fee and procedures for retaining
 1420  the fingerprints, performing the searches, and disseminating the
 1421  search results. The department shall notify the Department of
 1422  Law Enforcement of any change in a person’s status as a person
 1423  listed in s. 458.3265 if, as a result of the change, the
 1424  person’s fingerprints are no longer required to be retained
 1425  under paragraph (a).
 1426         (7)The State Surgeon General shall order a clinic closed
 1427  for operations if closure is warranted following failure of the
 1428  owner or operator of the clinic to pass a background check of
 1429  his or her criminal history. As determined by rule, the
 1430  department may grant an exemption if more than 10 years have
 1431  elapsed since adjudication.
 1432         (8)By January 3, 2011, the department and the Department
 1433  of Law Enforcement shall adopt rules pursuant to ss. 120.536(1)
 1434  and 120.54 to administer the provisions of this section, which
 1435  shall include, as necessary, the reporting, management,
 1436  development, and implementation of the fingerprint requirements
 1437  in this section.
 1438         Section 13. This act shall take effect July 1, 2010.

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