ENROLLED
       2009 Legislature         CS for CS for CS for CS for SB 462, 1st
                                                              Engrossed
       
       
       
       
       
                                                              2009462er
    1  
    2         An act relating to prescription drugs; creating s.
    3         893.055, F.S.; providing definitions; requiring the
    4         Department of Health to establish a comprehensive
    5         electronic database system to monitor the prescribing
    6         and dispensing of certain controlled substances;
    7         requiring specified prescribing and dispensing
    8         information to be reported to the electronic database
    9         system; requiring the department to establish policies
   10         and procedures for the system; requiring the
   11         department, in consultation with the Office of Drug
   12         Control and specified organizations, to adopt by rules
   13         appropriate for the prescription drug monitoring
   14         program; providing reporting requirements; providing a
   15         reporting period; providing exemptions from
   16         participation in the system; authorizing the
   17         department to establish when to suspend and when to
   18         resume reporting requirements during declared
   19         emergencies; requiring all nonexempt, dispensing
   20         pharmacists and practitioners to submit information in
   21         a specified format; providing that the cost to the
   22         dispenser in submitting the required information may
   23         not be material or extraordinary; specifying costs
   24         that are not material or extraordinary; providing
   25         access to information reported to the system under
   26         certain circumstances; providing that information in
   27         the database for the electronic prescription drug
   28         monitoring system is not discoverable or admissible in
   29         any civil or administrative action; providing
   30         exceptions; providing for the use of data for
   31         specified purposes; providing requirements for
   32         verification of information requested; requiring data
   33         transmission to comply with state and federal privacy
   34         and security laws; authorizing an agency or person to
   35         maintain the data for a specified period if the data
   36         is pertinent to active health care or law enforcement
   37         investigation or prosecution; requiring the annual
   38         reporting of certain performance measures to the
   39         Governor and Legislature; providing performance
   40         measure criteria; providing criminal penalties for
   41         violations; requiring that all costs incurred by the
   42         department for the program be funded through federal
   43         grants or available private funding sources; providing
   44         requirements for seeking funding and procuring goods
   45         or services; authorizing the Office of Drug Control,
   46         in coordination with the department, to establish a
   47         direct-support organization; providing a definition;
   48         providing for a board of directors appointed by the
   49         director of the office; requiring the director to
   50         provide guidance to the board regarding acceptance of
   51         moneys from appropriate sources; requiring the direct
   52         support organization to operate under written contract
   53         with the office; providing contract requirements;
   54         providing requirements for the direct-support
   55         organization’s collecting, expending, and providing of
   56         funds; requiring department approval of activities of
   57         the direct-support organization; authorizing the
   58         office to adopt rules for the use of certain
   59         facilities and services; providing for audits;
   60         prohibiting the direct-support organization from
   61         exercising certain powers; establishing that a
   62         prescriber or dispenser is not liable for good faith
   63         use of the department-provided controlled substance
   64         prescription information of a patient; requiring the
   65         department, in collaboration with the office, to study
   66         the feasibility of enhancing the prescription drug
   67         monitoring program for specified purposes to the
   68         extent that funding is provided for such purpose;
   69         requiring certain persons to present specified
   70         identification in order to obtain controlled
   71         substances; providing for recordkeeping for certain
   72         transactions; requiring the Agency for Health Care
   73         Administration to continue the promotion of electronic
   74         prescribing and an electronic prescribing
   75         clearinghouse; requiring the department to adopt
   76         rules; establishing a Program Implementation and
   77         Oversight Task Force; providing for membership;
   78         providing for reimbursement of certain member
   79         expenses; providing for meetings; providing the
   80         purpose of the task force; requiring reports to the
   81         Governor and Legislature; providing for the creation,
   82         membership, and duties of subcommittees; authorizing
   83         the direct-support organization to collect, expend,
   84         and provide funds and other assistance to the
   85         department; providing for a final report and the
   86         termination of the task force; amending ss. 458.309
   87         and 459.005, F.S.; requiring certain physicians who
   88         engage in pain management to register their clinics
   89         with the department by a specified date; providing an
   90         exception; prohibiting certain physicians from
   91         practicing in a pain-management clinic that has not
   92         registered with the department; requiring the
   93         department to inspect each facility; providing for
   94         exceptions; requiring the physician seeking to
   95         register the clinic to pay the costs of registration
   96         and inspection or accreditation; requiring the Board
   97         of Medicine and the Board of Osteopathic Medicine to
   98         adopt rules setting forth standards of practice for
   99         certain physicians who engage in pain management;
  100         providing criteria for the rules; providing an
  101         effective date.
  102  
  103         WHEREAS, as has been advocated by numerous pain management
  104  experts, addiction medicine experts, pharmacists, and law
  105  enforcement personnel, a prescription drug monitoring program
  106  that provides for reporting and advisory information and other
  107  specified information is established pursuant to this act to
  108  serve as a means to promote the public health and welfare and to
  109  detect and prevent controlled substance abuse and diversion, and
  110         WHEREAS, while the importance and necessity of the proper
  111  prescribing, dispensing, and monitoring of controlled
  112  substances, particularly pain medication, have been established,
  113  controlled prescription drugs are too often diverted in this
  114  state, often through fraudulent means, including outright theft,
  115  phony pharmacy fronts, loose Internet medical evaluations, and
  116  inappropriate importation; in addition, there is a criminal
  117  element that facilitates the prescription drug abuse epidemic
  118  through illegal profitmaking from the diversion of certain
  119  controlled substances that are prescribed or dispensed by
  120  physicians, health care practitioners, and pharmacists, and
  121         WHEREAS, in 2007, 8,620 drug-related deaths occurred in
  122  this state, 3,159 of which were caused by prescription drugs, an
  123  average of nearly 9 Floridians dying each day from prescription
  124  drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
  125  were found to be present in more drug-related deaths than
  126  cocaine; and opiate pain medications were found to be
  127  contributing to the increasing numbers of drug-related deaths,
  128  and
  129         WHEREAS, pharmaceutical drug diversion hurts this state
  130  significantly in terms of lost lives, increased crime, human
  131  misery from addiction, and ballooning health care costs
  132  connected to treatment, medical expenses, and Medicaid fraud
  133  that all Floridians ultimately bear, and
  134         WHEREAS, the intent of this act is not to interfere with
  135  the legitimate medical use of controlled substances; however,
  136  the people of this state are in need of and will benefit from a
  137  secure and privacy-protected statewide electronic system of
  138  specified prescription drug medication information created
  139  primarily to encourage safer controlled substance prescription
  140  decisions that reduce the number of prescription drug overdoses
  141  and the number of drug overdose deaths; to educate and inform
  142  health care practitioners and provide an added tool in patient
  143  care, including appropriate treatment for patients who have
  144  become addicted; to guide public health initiatives to educate
  145  the population on the dangers of misusing prescription drugs; to
  146  prevent the abuse or diversion of prescribed controlled
  147  substances; and to ensure that those who need prescribed
  148  controlled substances receive them in a manner that protects
  149  patient confidentiality, and
  150         WHEREAS, while certain medicines are very helpful if
  151  properly prescribed to a patient in need and then used as
  152  prescribed, they may be dangerous or even deadly if improperly
  153  dispensed, misused, or diverted, and
  154         WHEREAS, it is the intent of the Legislature to encourage
  155  patient safety, responsible pain management, and proper access
  156  to useful prescription drugs that are prescribed by a
  157  knowledgeable, properly licensed health care practitioner who
  158  dispenses prescription drugs and that are dispensed by a
  159  pharmacist who is made aware of the patient’s prescription drug
  160  medication history, thus preventing, in some cases, an abuse or
  161  addiction problem from developing or worsening, making such a
  162  problem possible or easier to identify, and facilitating the
  163  order of appropriate medical treatment or referral, and
  164         WHEREAS, such an electronic system will also aid
  165  administrative and law enforcement agencies in an active
  166  controlled substance-related investigation and will allow
  167  decisions and recommendations for pursuing appropriate
  168  administrative or criminal actions while maintaining such
  169  information for any such investigation with a reasonable, good
  170  faith anticipation of securing an arrest or prosecution in the
  171  foreseeable future, and
  172         WHEREAS, a Program Implementation and Oversight Task Force
  173  will provide information to the Governor and Legislature
  174  regarding the implementation of the program and ensure that
  175  privacy and confidentiality of the patient’s prescription
  176  history is respected, NOW, THEREFORE,
  177  
  178  Be It Enacted by the Legislature of the State of Florida:
  179  
  180         Section 1. Section 893.055, Florida Statutes, is created to
  181  read:
  182         893.055Prescription drug monitoring program.—
  183         (1)As used in this section, the term:
  184         (a)“Patient advisory report” or “advisory report” means
  185  information provided by the department in writing, or as
  186  determined by the department, to a prescriber, dispenser,
  187  pharmacy, or patient concerning the dispensing of controlled
  188  substances. All advisory reports are for informational purposes
  189  only and impose no obligations of any nature or any legal duty
  190  on a prescriber, dispenser, pharmacy, or patient. The patient
  191  advisory report shall be provided in accordance with s.
  192  893.13(7)(a)8. The advisory reports issued by the department are
  193  not subject to discovery or introduction into evidence in any
  194  civil or administrative action against a prescriber, dispenser,
  195  pharmacy, or patient arising out of matters that are the subject
  196  of the report, and a person who participates in preparing,
  197  reviewing, issuing, or any other activity related to an advisory
  198  report may not be permitted or required to testify in any such
  199  civil action as to any findings, recommendations, evaluations,
  200  opinions, or other actions taken in connection with preparing,
  201  reviewing, or issuing such a report.
  202         (b)“Controlled substance” means a controlled substance
  203  listed in Schedule II, Schedule III, or Schedule IV in s.
  204  893.03.
  205         (c)“Dispenser” means a pharmacy, dispensing pharmacist, or
  206  dispensing health care practitioner.
  207         (d)“Health care practitioner” or “practitioner” means any
  208  practitioner who is subject to licensure or regulation by the
  209  department under chapter 458, chapter 459, chapter 461, chapter
  210  462, chapter 464, chapter 465, or chapter 466.
  211         (e)“Health care regulatory board” means any board for a
  212  practitioner or health care practitioner who is licensed or
  213  regulated by the department.
  214         (f)“Pharmacy” means any pharmacy that is subject to
  215  licensure or regulation by the department under chapter 465 and
  216  that dispenses or delivers a controlled substance to an
  217  individual or address in this state.
  218         (g)“Prescriber” means a prescribing physician, prescribing
  219  practitioner, or other prescribing health care practitioner.
  220         (h)“Active investigation” means an investigation that is
  221  being conducted with a reasonable, good faith belief that it
  222  could lead to the filing of administrative, civil, or criminal
  223  proceedings, or that is ongoing and continuing and for which
  224  there is a reasonable, good faith anticipation of securing an
  225  arrest or prosecution in the foreseeable future.
  226         (i)“Law enforcement agency” means the Department of Law
  227  Enforcement, a Florida sheriff’s department, a Florida police
  228  department, or a law enforcement agency of the Federal
  229  Government which enforces the laws of this state or the United
  230  States relating to controlled substances, and which its agents
  231  and officers are empowered by law to conduct criminal
  232  investigations and make arrests.
  233         (2)(a)By December 1, 2010, the department shall design and
  234  establish a comprehensive electronic database system that has
  235  controlled substance prescriptions provided to it and that
  236  provides prescription information to a patient’s health care
  237  practitioner and pharmacist who inform the department that they
  238  wish the patient advisory report provided to them. Otherwise,
  239  the patient advisory report will not be sent to the
  240  practitioner, pharmacy, or pharmacist. The system shall be
  241  designed to provide information regarding dispensed
  242  prescriptions of controlled substances and shall not infringe
  243  upon the legitimate prescribing or dispensing of a controlled
  244  substance by a prescriber or dispenser acting in good faith and
  245  in the course of professional practice. The system shall be
  246  consistent with standards of the American Society for Automation
  247  in Pharmacy (ASAP). The electronic system shall also comply with
  248  the Health Insurance Portability and Accountability Act (HIPAA)
  249  as it pertains to protected health information (PHI), electronic
  250  protected health information (EPHI), and all other relevant
  251  state and federal privacy and security laws and regulations. The
  252  department shall establish policies and procedures as
  253  appropriate regarding the reporting, accessing the database,
  254  evaluation, management, development, implementation, operation,
  255  storage, and security of information within the system. The
  256  reporting of prescribed controlled substances shall include a
  257  dispensing transaction with a dispenser pursuant to chapter 465
  258  or through a dispensing transaction to an individual or address
  259  in this state with a pharmacy that is not located in this state
  260  but that is otherwise subject to the jurisdiction of this state
  261  as to that dispensing transaction. The reporting of patient
  262  advisory reports refers only to reports to patients, pharmacies,
  263  and practitioners. Separate reports that contain patient
  264  prescription history information and that are not patient
  265  advisory reports are provided to persons and entities as
  266  authorized in paragraphs (7)(b) and (c) and s. 893.0551.
  267         (b)The department, when the direct support organization
  268  receives at least $20,000 in nonstate moneys or the state
  269  receives at least $20,000 in federal grants for the prescription
  270  drug monitoring program, and in consultation with the Office of
  271  Drug Control, shall adopt rules as necessary concerning the
  272  reporting, accessing the database, evaluation, management,
  273  development, implementation, operation, security, and storage of
  274  information within the system, including rules for when patient
  275  advisory reports are provided to pharmacies and prescribers. The
  276  patient advisory report shall be provided in accordance with s.
  277  893.13(7)(a)8. The department shall work with the professional
  278  health care licensure boards, such as the Board of Medicine, the
  279  Board of Osteopathic Medicine, and the Board of Pharmacy; other
  280  appropriate organizations, such as the Florida Pharmacy
  281  Association, the Office of Drug Control, the Florida Medical
  282  Association, the Florida Retail Federation and the Florida
  283  Osteopathic Medical Association, including those relating to
  284  pain management; and the Attorney General, the Department of Law
  285  Enforcement, and the Agency for Health Care Administration to
  286  develop rules appropriate for the prescription drug monitoring
  287  program.
  288         (c)All dispensers and prescribers subject to these
  289  reporting requirements shall be notified by the department of
  290  the implementation date for such reporting requirements.
  291         (3)The pharmacy dispensing the controlled substance and
  292  each prescriber who directly dispenses a controlled substance
  293  shall submit to the electronic system, by a procedure and in a
  294  format established by the department and consistent with an
  295  ASAP-approved format, the following information for inclusion in
  296  the database:
  297         (a)The name of the prescribing practitioner, the
  298  practitioner’s federal Drug Enforcement Administration
  299  registration number, the practitioner’s National Provider
  300  Identification (NPI) or other appropriate identifier, and the
  301  date of the prescription.
  302         (b)The date the prescription was filled and the method of
  303  payment, such as cash by an individual, insurance coverage
  304  through a third party, or Medicaid payment. This paragraph does
  305  not authorize the department to include individual credit card
  306  numbers or other account numbers in the database.
  307         (c)The full name, address, and date of birth of the person
  308  for whom the prescription was written.
  309         (d)The name, national drug code, quantity, and strength of
  310  the controlled substance dispensed.
  311         (e)The full name, federal Drug Enforcement Administration
  312  registration number, and address of the pharmacy or other
  313  location from which the controlled substance was dispensed. If
  314  the controlled substance was dispensed by a practitioner other
  315  than a pharmacist, the practitioner’s full name, federal Drug
  316  Enforcement Administration registration number, and address.
  317         (f)The name of the pharmacy or practitioner, other than a
  318  pharmacist, dispensing the controlled substance and the
  319  practitioner’s National Provider Identification (NPI).
  320         (g)Other appropriate identifying information as determined
  321  by department rule.
  322         (4)Each time a controlled substance is dispensed to an
  323  individual, the controlled substance shall be reported to the
  324  department through the system as soon thereafter as possible,
  325  but not more than 15 days after the date the controlled
  326  substance is dispensed unless an extension is approved by the
  327  department for cause as determined by rule. A dispenser must
  328  meet the reporting requirements of this section by providing the
  329  required information concerning each controlled substance that
  330  it dispensed in a department-approved, secure methodology and
  331  format. Such approved formats may include, but are not limited
  332  to, submission via the Internet, on a disc, or by use of regular
  333  mail.
  334         (5)When the following acts of dispensing or administering
  335  occur, the following are exempt from reporting under this
  336  section for that specific act of dispensing or administration:
  337         (a)A health care practitioner when administering a
  338  controlled substance directly to a patient if the amount of the
  339  controlled substance is adequate to treat the patient during
  340  that particular treatment session.
  341         (b)A pharmacist or health care practitioner when
  342  administering a controlled substance to a patient or resident
  343  receiving care as a patient at a hospital, nursing home,
  344  ambulatory surgical center, hospice, or intermediate care
  345  facility for the developmentally disabled which is licensed in
  346  this state.
  347         (c)A practitioner when administering or dispensing a
  348  controlled substance in the health care system of the Department
  349  of Corrections.
  350         (d)A practitioner when administering a controlled
  351  substance in the emergency room of a licensed hospital.
  352         (e)A health care practitioner when administering or
  353  dispensing a controlled substance to a person under the age of
  354  16.
  355         (f)A pharmacist or a dispensing practitioner when
  356  dispensing a one-time, 72-hour emergency resupply of a
  357  controlled substance to a patient.
  358         (6)The department may establish when to suspend and when
  359  to resume reporting information during a state-declared or
  360  nationally declared disaster.
  361         (7)(a)A practitioner or pharmacist who dispenses a
  362  controlled substance must submit the information required by
  363  this section in an electronic or other method in an ASAP format
  364  approved by rule of the department unless otherwise provided in
  365  this section. The cost to the dispenser in submitting the
  366  information required by this section may not be material or
  367  extraordinary. Costs not considered to be material or
  368  extraordinary include, but are not limited to, regular postage,
  369  electronic media, regular electronic mail, and facsimile
  370  charges.
  371         (b)A pharmacy, prescriber, or dispenser shall have access
  372  to information in the prescription drug monitoring program’s
  373  database which relates to a patient of that pharmacy,
  374  prescriber, or dispenser in a manner established by the
  375  department as needed for the purpose of reviewing the patient’s
  376  controlled substance prescription history. Other access to the
  377  program’s database shall be limited to the program’s manager and
  378  to the designated program and support staff, who may act only at
  379  the direction of the program manager or, in the absence of the
  380  program manager, as authorized. Access by the program manager or
  381  such designated staff is for prescription drug program
  382  management only or for management of the program’s database and
  383  its system in support of the requirements of this section and in
  384  furtherance of the prescription drug monitoring program.
  385  Confidential and exempt information in the database shall be
  386  released only as provided in paragraph (c) and s. 893.0551.
  387         (c)The following entities shall not be allowed direct
  388  access to information in the prescription drug monitoring
  389  program database but may request from the program manager and,
  390  when authorized by the program manager, the program manager’s
  391  program and support staff, information that is confidential and
  392  exempt under s. 893.0551. Prior to release, the request shall be
  393  verified as authentic and authorized with the requesting
  394  organization by the program manager, the program manager’s
  395  program and support staff, or as determined in rules by the
  396  department as being authentic and as having been authorized by
  397  the requesting entity:
  398         1.The department or its relevant health care regulatory
  399  boards responsible for the licensure, regulation, or discipline
  400  of practitioners, pharmacists, or other persons who are
  401  authorized to prescribe, administer, or dispense controlled
  402  substances and who are involved in a specific controlled
  403  substance investigation involving a designated person for one or
  404  more prescribed controlled substances.
  405         2.The Attorney General for Medicaid fraud cases involving
  406  prescribed controlled substances.
  407         3.A law enforcement agency during active investigations
  408  regarding potential criminal activity, fraud, or theft regarding
  409  prescribed controlled substances.
  410         4.A patient or the legal guardian or designated health
  411  care surrogate of an incapacitated patient as described in s.
  412  893.0551 who, for the purpose of verifying the accuracy of the
  413  database information, submits a written and notarized request
  414  that includes the patient’s full name, address, and date of
  415  birth, and includes the same information if the legal guardian
  416  or health care surrogate submits the request. The request shall
  417  be validated by the department to verify the identity of the
  418  patient and the legal guardian or health care surrogate, if the
  419  patient’s legal guardian or health care surrogate is the
  420  requestor. Such verification is also required for any request to
  421  change a patient’s prescription history or other information
  422  related to his or her information in the electronic database.
  423  
  424  Information in the database for the electronic prescription drug
  425  monitoring system is not discoverable or admissible in any civil
  426  or administrative action, except in an investigation and
  427  disciplinary proceeding by the department or the appropriate
  428  regulatory board.
  429         (d)The following entities shall not be allowed direct
  430  access to information in the prescription drug monitoring
  431  program database but may request from the program manager and,
  432  when authorized by the program manager, the program manager’s
  433  program and support staff, information that contains no
  434  identifying information of any patient, physician, health care
  435  practitioner, prescriber, or dispenser and that is not
  436  confidential and exempt:
  437         1.Department staff for the purpose of calculating
  438  performance measures pursuant to subsection (8).
  439         2.The Program Implementation and Oversight Task Force for
  440  its reporting to the Governor, the President of the Senate, and
  441  the Speaker of the House of Representatives regarding the
  442  prescription drug monitoring program. This subparagraph expires
  443  July 1, 2012.
  444         (e)All transmissions of data required by this section must
  445  comply with relevant state and federal privacy and security laws
  446  and regulations. However, any authorized agency or person under
  447  s. 893.0551 receiving such information as allowed by s. 893.0551
  448  may maintain the information received for up to 24 months before
  449  purging it from his or her records or maintain it for longer
  450  than 24 months if the information is pertinent to ongoing health
  451  care or an active law enforcement investigation or prosecution.
  452         (8)To assist in fulfilling program responsibilities,
  453  performance measures shall be reported annually to the Governor,
  454  the President of the Senate, and the Speaker of the House of
  455  Representatives by the department each December 1, beginning in
  456  2011. Data that does not contain patient, physician, health care
  457  practitioner, prescriber, or dispenser identifying information
  458  may be requested during the year by department employees so that
  459  the department may undertake public health care and safety
  460  initiatives that take advantage of observed trends. Performance
  461  measures may include, but are not limited to, efforts to achieve
  462  the following outcomes:
  463         (a)Reduction of the rate of inappropriate use of
  464  prescription drugs through department education and safety
  465  efforts.
  466         (b)Reduction of the quantity of pharmaceutical controlled
  467  substances obtained by individuals attempting to engage in fraud
  468  and deceit.
  469         (c)Increased coordination among partners participating in
  470  the prescription drug monitoring program.
  471         (d)Involvement of stakeholders in achieving improved
  472  patient health care and safety and reduction of prescription
  473  drug abuse and prescription drug diversion.
  474         (9)Any person who willfully and knowingly fails to report
  475  the dispensing of a controlled substance as required by this
  476  section commits a misdemeanor of the first degree, punishable as
  477  provided in s. 775.082 or s. 775.083.
  478         (10)All costs incurred by the department in administering
  479  the prescription drug monitoring program shall be funded through
  480  federal grants or private funding applied for or received by the
  481  state. The department may not commit funds for the monitoring
  482  program without ensuring funding is available. The prescription
  483  drug monitoring program and the implementation thereof are
  484  contingent upon receipt of the nonstate funding. The department
  485  and state government shall cooperate with the direct-support
  486  organization established pursuant to subsection (11) in seeking
  487  federal grant funds, other nonstate grant funds, gifts,
  488  donations, or other private moneys for the department so long as
  489  the costs of doing so are not considered material. Nonmaterial
  490  costs for this purpose include, but are not limited to, the
  491  costs of mailing and personnel assigned to research or apply for
  492  a grant. Notwithstanding the exemptions to competitive
  493  solicitation requirements under s. 287.057(5)(f), the department
  494  shall comply with the competitive-solicitation requirements
  495  under s. 287.057 for the procurement of any goods or services
  496  required by this section.
  497         (11)The Office of Drug Control, in coordination with the
  498  department, may establish a direct-support organization that has
  499  a board consisting of at least five members to provide
  500  assistance, funding, and promotional support for the activities
  501  authorized for the prescription drug monitoring program.
  502         (a)As used in this subsection, the term “direct-support
  503  organization” means an organization that is:
  504         1.A Florida corporation not for profit incorporated under
  505  chapter 617, exempted from filing fees, and approved by the
  506  Department of State.
  507         2.Organized and operated to conduct programs and
  508  activities; raise funds; request and receive grants, gifts, and
  509  bequests of money; acquire, receive, hold, and invest, in its
  510  own name, securities, funds, objects of value, or other
  511  property, either real or personal; and make expenditures or
  512  provide funding to or for the direct or indirect benefit of the
  513  department in the furtherance of the prescription drug
  514  monitoring program.
  515         (b)The direct-support organization is not considered a
  516  lobbying firm within the meaning of s. 11.045.
  517         (c)The director of the Office of Drug Control shall
  518  appoint a board of directors for the direct-support
  519  organization. The director may designate employees of the Office
  520  of Drug Control, state employees other than state employees from
  521  the department, and any other nonstate employees as appropriate,
  522  to serve on the board. Members of the board shall serve at the
  523  pleasure of the director of the Office of Drug Control. The
  524  director shall provide guidance to members of the board to
  525  ensure that moneys received by the direct-support organization
  526  are not received from inappropriate sources. Inappropriate
  527  sources include, but are not limited to, donors, grantors,
  528  persons, or organizations that may monetarily or substantively
  529  benefit from the purchase of goods or services by the department
  530  in furtherance of the prescription drug monitoring program.
  531         (d)The direct-support organization shall operate under
  532  written contract with the Office of Drug Control. The contract
  533  must, at a minimum, provide for:
  534         1.Approval of the articles of incorporation and bylaws of
  535  the direct-support organization by the Office of Drug Control.
  536         2.Submission of an annual budget for the approval of the
  537  Office of Drug Control.
  538         3.Certification by the Office of Drug Control in
  539  consultation with the department that the direct-support
  540  organization is complying with the terms of the contract in a
  541  manner consistent with and in furtherance of the goals and
  542  purposes of the prescription drug monitoring program and in the
  543  best interests of the state. Such certification must be made
  544  annually and reported in the official minutes of a meeting of
  545  the direct-support organization.
  546         4.The reversion, without penalty, to the Office of Drug
  547  Control, or to the state if the Office of Drug Control ceases to
  548  exist, of all moneys and property held in trust by the direct
  549  support organization for the benefit of the prescription drug
  550  monitoring program if the direct-support organization ceases to
  551  exist or if the contract is terminated.
  552         5.The fiscal year of the direct-support organization,
  553  which must begin July 1 of each year and end June 30 of the
  554  following year.
  555         6.The disclosure of the material provisions of the
  556  contract to donors of gifts, contributions, or bequests,
  557  including such disclosure on all promotional and fundraising
  558  publications, and an explanation to such donors of the
  559  distinction between the Office of Drug Control and the direct
  560  support organization.
  561         7.The direct-support organization’s collecting, expending,
  562  and providing of funds to the department for the development,
  563  implementation, and operation of the prescription drug
  564  monitoring program as described in this section and section 2 of
  565  this act as long as the task force is authorized. The direct
  566  support organization may collect and expend funds to be used for
  567  the functions of the direct-support organization’s board of
  568  directors, as necessary and approved by the director of the
  569  Office of Drug Control. In addition, the direct-support
  570  organization may collect and provide funding to the department
  571  in furtherance of the prescription drug monitoring program by:
  572         a.Establishing and administering the prescription drug
  573  monitoring program’s electronic database, including hardware and
  574  software.
  575         b.Conducting studies on the efficiency and effectiveness
  576  of the program to include feasibility studies as described in
  577  subsection (13).
  578         c.Providing funds for future enhancements of the program
  579  within the intent of this section.
  580         d.Providing user training of the prescription drug
  581  monitoring program, including distribution of materials to
  582  promote public awareness and education and conducting workshops
  583  or other meetings, for health care practitioners, pharmacists,
  584  and others as appropriate.
  585         e.Providing funds for travel expenses.
  586         f.Providing funds for administrative costs, including
  587  personnel, audits, facilities, and equipment.
  588         g.Fulfilling all other requirements necessary to implement
  589  and operate the program as outlined in this section.
  590         (e)The activities of the direct-support organization must
  591  be consistent with the goals and mission of the Office of Drug
  592  Control, as determined by the office in consultation with the
  593  department, and in the best interests of the state. The direct
  594  support organization must obtain a written approval from the
  595  director of the Office of Drug Control for any activities in
  596  support of the prescription drug monitoring program before
  597  undertaking those activities.
  598         (f)The Office of Drug Control, in consultation with the
  599  department, may permit, without charge, appropriate use of
  600  administrative services, property, and facilities of the Office
  601  of Drug Control and the department by the direct-support
  602  organization, subject to this section. The use must be directly
  603  in keeping with the approved purposes of the direct-support
  604  organization and may not be made at times or places that would
  605  unreasonably interfere with opportunities for the public to use
  606  such facilities for established purposes. Any moneys received
  607  from rentals of facilities and properties managed by the Office
  608  of Drug Control and the department may be held by the Office of
  609  Drug Control or in a separate depository account in the name of
  610  the direct-support organization and subject to the provisions of
  611  the letter of agreement with the Office of Drug Control. The
  612  letter of agreement must provide that any funds held in the
  613  separate depository account in the name of the direct-support
  614  organization must revert to the Office of Drug Control if the
  615  direct-support organization is no longer approved by the Office
  616  of Drug Control to operate in the best interests of the state.
  617         (g)The Office of Drug Control, in consultation with the
  618  department, may adopt rules under s. 120.54 to govern the use of
  619  administrative services, property, or facilities of the
  620  department or office by the direct-support organization.
  621         (h)The Office of Drug Control may not permit the use of
  622  any administrative services, property, or facilities of the
  623  state by a direct-support organization if that organization does
  624  not provide equal membership and employment opportunities to all
  625  persons regardless of race, color, religion, gender, age, or
  626  national origin.
  627         (i)The direct-support organization shall provide for an
  628  independent annual financial audit in accordance with s.
  629  215.981. Copies of the audit shall be provided to the Office of
  630  Drug Control and the Office of Policy and Budget in the
  631  Executive Office of the Governor.
  632         (j)The direct-support organization may not exercise any
  633  power under s. 617.0302(12) or (16).
  634         (12)A prescriber or dispenser may have access to the
  635  information under this section which relates to a patient of
  636  that prescriber or dispenser as needed for the purpose of
  637  reviewing the patient’s controlled drug prescription history. A
  638  prescriber or dispenser acting in good faith is immune from any
  639  civil, criminal, or administrative liability that might
  640  otherwise be incurred or imposed for receiving or using
  641  information from the prescription drug monitoring program. This
  642  subsection does not create a private cause of action, and a
  643  person may not recover damages against a prescriber or dispenser
  644  authorized to access information under this subsection for
  645  accessing or failing to access such information.
  646         (13)To the extent that funding is provided for such
  647  purpose through federal or private grants or gifts and other
  648  types of available moneys, the department, in collaboration with
  649  the Office of Drug Control, shall study the feasibility of
  650  enhancing the prescription drug monitoring program for the
  651  purposes of public health initiatives and statistical reporting
  652  that respects the privacy of the patient, the prescriber, and
  653  the dispenser. Such a study shall be conducted in order to
  654  further improve the quality of health care services and safety
  655  by improving the prescribing and dispensing practices for
  656  prescription drugs, taking advantage of advances in technology,
  657  reducing duplicative prescriptions and the overprescribing of
  658  prescription drugs, and reducing drug abuse. The requirements of
  659  the National All Schedules Prescription Electronic Reporting
  660  (NASPER) Act are authorized in order to apply for federal NASPER
  661  funding. In addition, the direct-support organization shall
  662  provide funding for the department, in collaboration with the
  663  Office of Drug Control, to conduct training for health care
  664  practitioners and other appropriate persons in using the
  665  monitoring program to support the program enhancements.
  666         (14)A pharmacist, pharmacy, or dispensing health care
  667  practitioner or his or her agent, before releasing a controlled
  668  substance to any person not known to such dispenser, shall
  669  require the person purchasing, receiving, or otherwise acquiring
  670  the controlled substance to present valid photographic
  671  identification or other verification of his or her identity to
  672  the dispenser. If the person does not have proper
  673  identification, the dispenser may verify the validity of the
  674  prescription and the identity of the patient with the prescriber
  675  or his or her authorized agent. Verification of health plan
  676  eligibility through a real-time inquiry or adjudication system
  677  will be considered to be proper identification. This subsection
  678  does not apply in an institutional setting or to a long-term
  679  care facility, including, but not limited to, an assisted living
  680  facility or a hospital to which patients are admitted. As used
  681  in this subsection, the term “proper identification” means an
  682  identification that is issued by a state or the Federal
  683  Government containing the person’s photograph, printed name, and
  684  signature or a document considered acceptable under 8 C.F.R.
  685  274a.2(b)(1)(v)(A) and (B).
  686         (15)The Agency for Health Care Administration shall
  687  continue the promotion of electronic prescribing by health care
  688  practitioners, health care facilities, and pharmacies under s.
  689  408.0611.
  690         (16)By October 1, 2010, the department shall adopt rules
  691  pursuant to ss. 120.536(1) and 120.54 to administer the
  692  provisions of this section, which shall include as necessary the
  693  reporting, accessing, evaluation, management, development,
  694  implementation, operation, and storage of information within the
  695  monitoring program’s system.
  696         Section 2. (1)The Program Implementation and Oversight
  697  Task Force is created within the Executive Office of the
  698  Governor. The director of the Office of Drug Control shall be a
  699  nonvoting, ex officio member of the task force and shall act as
  700  chair. The Office of Drug Control and the Department of Health
  701  shall provide staff support for the task force.
  702         (a)The following state officials shall serve on the task
  703  force:
  704         1.The Attorney General or his or her designee.
  705         2.The Secretary of Children and Family Services or his or
  706  her designee.
  707         3.The Secretary of Health Care Administration or his or
  708  her designee.
  709         4.The State Surgeon General or his or her designee.
  710         (b)In addition, the Governor shall appoint 12 members of
  711  the public to serve on the task force. Of these 12 appointed
  712  members, one member must have professional or occupational
  713  expertise in computer security; one member must be a Florida
  714  licensed, board-certified oncologist; two members must be
  715  Florida-licensed, fellowship-trained, pain-medicine physicians;
  716  one member must be a Florida-licensed primary care physician who
  717  has experience in prescribing scheduled prescription drugs; one
  718  member must have professional or occupational expertise in e
  719  Prescribing or prescription drug monitoring programs; two
  720  members must be a Florida-licensed pharmacists; one member must
  721  have professional or occupational expertise in the area of law
  722  enforcement and have experience in prescription drug
  723  investigations; one member must have professional or
  724  occupational expertise as an epidemiologist and have a
  725  background in tracking and analyzing drug trends; and two
  726  members must have professional or occupational expertise as
  727  providers of substance abuse treatment, with priority given to a
  728  member who is a former substance abuser.
  729         (c)Members appointed by the Governor shall be appointed to
  730  a term of 3 years each. Any vacancy on the task force shall be
  731  filled in the same manner as the original appointment, and any
  732  member appointed to fill a vacancy shall serve only for the
  733  unexpired term of the member’s predecessor.
  734         (d)Members of the task force and members of subcommittees
  735  appointed under subsection (4) shall serve without compensation,
  736  but are entitled to reimbursement for per diem and travel
  737  expenses as provided in s. 112.061, Florida Statutes.
  738         (e)The task force shall meet at least quarterly or upon
  739  the call of the chair.
  740         (2)The purpose of the task force is to monitor the
  741  implementation and safeguarding of the electronic system
  742  established for the prescription drug monitoring program under
  743  s. 893.055, Florida Statutes, and to ensure privacy, protection
  744  of individual medication history, and the electronic system’s
  745  appropriate use by physicians, dispensers, pharmacies, law
  746  enforcement agencies, and those authorized to request
  747  information from the electronic system.
  748         (3)The Office of Drug Control shall submit a report to the
  749  Governor, the President of the Senate, and the Speaker of the
  750  House of Representatives by December 1 of each year which
  751  contains a summary of the work of the task force during that
  752  year and the recommendations developed in accordance with the
  753  task force’s purpose as provided in subsection (2). Interim
  754  reports may be submitted at the discretion of the chair.
  755         (4)The chair of the task force may appoint subcommittees
  756  that include members of state agencies that are not represented
  757  on the task force for the purpose of soliciting input and
  758  recommendations from those state agencies as needed by the task
  759  force to accomplish its purpose as provided in subsection (2).
  760  In addition, the chair may appoint subcommittees as necessary
  761  from among the members of the task force in order to efficiently
  762  address specific issues. If a state agency is to be represented
  763  on any subcommittee, the representative shall be the head of the
  764  agency or his or her designee. The chair may designate lead and
  765  contributing agencies within a subcommittee.
  766         (5)The direct-support organization created in s. 893.055,
  767  Florida Statutes, may collect, expend, and provide funds and
  768  other assistance to the department for the development,
  769  implementation, and operation of the task force.
  770         (6)The task force shall provide a final report in
  771  accordance with the task force’s purpose as provided in
  772  subsection (2) on July 1, 2012, to the Governor, the President
  773  of the Senate, and the Speaker of the House of Representatives.
  774  Such report shall be prepared using only data that does not
  775  identify a patient, a prescriber, or a dispenser. The task force
  776  shall expire and this section is repealed on that date unless
  777  reenacted by the Legislature.
  778         Section 3. Subsections (4), (5), and (6) are added to
  779  section 458.309, Florida Statutes, to read:
  780         458.309 Rulemaking authority.—
  781         (4)All privately owned pain-management clinics,
  782  facilities, or offices, hereinafter referred to as “clinics,”
  783  which advertise in any medium for any type of pain-management
  784  services, or employ a physician who is primarily engaged in the
  785  treatment of pain by prescribing or dispensing controlled
  786  substance medications, must register with the department by
  787  January 4, 2010, unless that clinic is licensed as a facility
  788  pursuant to chapter 395. A physician may not practice medicine
  789  in a pain-management clinic that is required to but has not
  790  registered with the department. Each clinic location shall be
  791  registered separately regardless of whether the clinic is
  792  operated under the same business name or management as another
  793  clinic. If the clinic is licensed as a health care clinic under
  794  chapter 400, the medical director is responsible for registering
  795  the facility with the department. If the clinic is not
  796  registered pursuant to chapter 395 or chapter 400, the clinic
  797  shall, upon registration with the department, designate a
  798  physician who is responsible for complying with all requirements
  799  related to registration of the clinic. The designated physician
  800  shall be licensed under this chapter or chapter 459 and shall
  801  practice at the office location for which the physician has
  802  assumed responsibility. The department shall inspect the clinic
  803  annually to ensure that it complies with rules of the Board of
  804  Medicine adopted pursuant to this subsection and subsection (5)
  805  unless the office is accredited by a nationally recognized
  806  accrediting agency approved by the Board of Medicine. The actual
  807  costs for registration and inspection or accreditation shall be
  808  paid by the physician seeking to register the clinic.
  809         (5)The Board of Medicine shall adopt rules setting forth
  810  standards of practice for physicians practicing in privately
  811  owned pain-management clinics that primarily engage in the
  812  treatment of pain by prescribing or dispensing controlled
  813  substance medications. Such rules shall address, but need not be
  814  limited to, the following subjects:
  815         (a)Facility operations;
  816         (b)Physical operations;
  817         (c)Infection control requirements;
  818         (d)Health and safety requirements;
  819         (e)Quality assurance requirements;
  820         (f)Patient records;
  821         (g)Training requirements for all facility health care
  822  practitioners who are not regulated by another board;
  823         (h)Inspections; and
  824         (i)Data collection and reporting requirements.
  825  
  826  A physician is primarily engaged in the treatment of pain by
  827  prescribing or dispensing controlled substance medications when
  828  the majority of the patients seen are prescribed or dispensed
  829  controlled substance medications for the treatment of chronic
  830  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  831  to cancer which persists beyond the usual course of the disease
  832  or the injury that is the cause of the pain or more than 90 days
  833  after surgery.
  834         (6)A privately owned clinic, facility, or office that
  835  advertises in any medium for any type of pain-management
  836  services or employs one or more physicians who are primarily
  837  engaged in the treatment of pain by prescribing or dispensing
  838  controlled substances is exempt from the registration provisions
  839  in subsection (4) if the majority of the physicians who provide
  840  services in the clinic, facility, or office primarily provide
  841  surgical services.
  842         Section 4. Subsections (3), (4), and (5) are added to
  843  section 459.005, Florida Statutes, to read:
  844         459.005 Rulemaking authority.—
  845         (3)All privately owned pain-management clinics,
  846  facilities, or offices, hereinafter referred to as “clinics,”
  847  which advertise in any medium for any type of pain-management
  848  services, or employ a physician who is licensed under this
  849  chapter and who is primarily engaged in the treatment of pain by
  850  prescribing or dispensing controlled substance medications, must
  851  register with the department by January 4, 2010, unless that
  852  clinic is licensed as a facility under chapter 395. A physician
  853  may not practice osteopathic medicine in a pain-management
  854  clinic that is required to but has not registered with the
  855  department. Each clinic location shall be registered separately
  856  regardless of whether the clinic is operated under the same
  857  business name or management as another clinic. If the clinic is
  858  licensed as a health care clinic under chapter 400, the medical
  859  director is responsible for registering the facility with the
  860  department. If the clinic is not registered under chapter 395 or
  861  chapter 400, the clinic shall, upon registration with the
  862  department, designate a physician who is responsible for
  863  complying with all requirements related to registration of the
  864  clinic. The designated physician shall be licensed under chapter
  865  458 or this chapter and shall practice at the office location
  866  for which the physician has assumed responsibility. The
  867  department shall inspect the clinic annually to ensure that it
  868  complies with rules of the Board of Osteopathic Medicine adopted
  869  pursuant to this subsection and subsection (4) unless the office
  870  is accredited by a nationally recognized accrediting agency
  871  approved by the Board of Osteopathic Medicine. The actual costs
  872  for registration and inspection or accreditation shall be paid
  873  by the physician seeking to register the clinic.
  874         (4)The Board of Osteopathic Medicine shall adopt rules
  875  setting forth standards of practice for physicians who practice
  876  in privately owned pain-management clinics that primarily engage
  877  in the treatment of pain by prescribing or dispensing controlled
  878  substance medications. Such rules shall address, but need not be
  879  limited to, the following subjects:
  880         (a)Facility operations;
  881         (b)Physical operations;
  882         (c)Infection control requirements;
  883         (d)Health and safety requirements;
  884         (e)Quality assurance requirements;
  885         (f)Patient records;
  886         (g)Training requirements for all facility health care
  887  practitioners who are not regulated by another board;
  888         (h)Inspections; and
  889         (i)Data collection and reporting requirements.
  890  
  891  A physician is primarily engaged in the treatment of pain by
  892  prescribing or dispensing controlled substance medications when
  893  the majority of the patients seen are prescribed or dispensed
  894  controlled substance medications for the treatment of chronic
  895  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  896  to cancer which persists beyond the usual course of the disease
  897  or the injury that is the cause of the pain or more than 90 days
  898  after surgery.
  899         (5)A privately owned clinic, facility, or office that
  900  advertises in any medium for any type of pain-management
  901  services or employs one or more physicians who are primarily
  902  engaged in the treatment of pain by prescribing or dispensing
  903  controlled substances is exempt from the registration provisions
  904  in subsection (3) if the majority of the physicians who provide
  905  services in the clinic, facility, or office primarily provide
  906  surgical services.
  907         Section 5. This act shall take effect July 1, 2009.