May 19, 2019
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       Florida Senate - 2010                             CS for SB 1722
       
       
       
       By the Committee on Health Regulation; and Senators Fasano and
       Gaetz
       
       
       
       588-02727A-10                                         20101722c1
    1                        A bill to be entitled                      
    2         An act relating to the prescription drug monitoring
    3         program; amending s. 893.055, F.S.; requiring that the
    4         comprehensive electronic database system containing
    5         information concerning prescriptions of controlled
    6         substances comply with the minimum requirements for
    7         authentication and certification of the National All
    8         Schedules Prescription Electronic Reporting Act;
    9         requiring the Department of Health to provide reports
   10         from the prescription drug monitoring program to the
   11         Department of Law Enforcement; requiring the
   12         Department of Health, after consultation with the
   13         Department of Law Enforcement and other associations,
   14         to adopt rules; requiring the Department of Health to
   15         establish a method to allow corrections to the program
   16         database; revising the information to be submitted to
   17         the program database by a pharmacy or prescriber;
   18         revising the acts of dispensing or administering
   19         controlled substances which are exempt from reporting;
   20         requiring a pharmacy, prescriber, practitioner, or
   21         dispenser to register with the Department of Health in
   22         order to obtain certain information from the
   23         prescription drug monitoring program; requiring the
   24         program manager and certain other individuals who have
   25         access to the prescription drug monitoring program
   26         database to submit fingerprints to the Department of
   27         Health; requiring the Department of Health to follow
   28         the proper procedures established by the Department of
   29         Law Enforcement to request state and national criminal
   30         history record checks; prohibiting the Agency for
   31         Health Care Administration from having direct access
   32         to information in the prescription drug monitoring
   33         program database for purposes of Medicaid fraud cases
   34         or investigations; requiring a patient, legal
   35         guardian, or designated health care surrogate to
   36         provide the patient’s phone number and a copy of a
   37         government-issued photo identification in order to
   38         verify information in the prescription drug monitoring
   39         program database; authorizing the State Surgeon
   40         General to enter into agreements with other states to
   41         exchange prescription drug monitoring information
   42         after specified conditions are met; providing factors
   43         for considering such agreements; limiting the purposes
   44         for which information may be shared under such
   45         agreements; amending s. 893.0551, F.S.; authorizing
   46         the disclosure of information in the prescription drug
   47         monitoring program under certain conditions; providing
   48         an effective date.
   49  
   50  Be It Enacted by the Legislature of the State of Florida:
   51  
   52         Section 1. Subsections (2), (3), (5), and (7) of section
   53  893.055, Florida Statutes, are amended, and subsection (8) is
   54  added to that section, to read:
   55         893.055 Prescription drug monitoring program.—
   56         (2)(a) By December 1, 2010, the department shall design and
   57  establish a comprehensive electronic database system that has
   58  controlled substance prescriptions provided to it and that
   59  provides prescription information to a patient’s health care
   60  practitioner and pharmacist who inform the department that they
   61  wish the patient advisory report provided to them. Otherwise,
   62  the patient advisory report will not be sent to the
   63  practitioner, pharmacy, or pharmacist. The system shall be
   64  designed to provide information regarding dispensed
   65  prescriptions of controlled substances and shall not infringe
   66  upon the legitimate prescribing or dispensing of a controlled
   67  substance by a prescriber or dispenser acting in good faith and
   68  in the course of professional practice. The system shall be
   69  consistent with standards of the American Society for Automation
   70  in Pharmacy (ASAP). The electronic system shall also comply with
   71  the Health Insurance Portability and Accountability Act (HIPAA)
   72  as it pertains to protected health information (PHI), electronic
   73  protected health information (EPHI), the National All Schedules
   74  Prescription Electronic Reporting (NASPER) Act’s minimum
   75  requirements for authentication of a practitioner that requests
   76  information in the prescription drug monitoring program database
   77  and certification of the purpose for which information is
   78  requested, and all other relevant state and federal privacy and
   79  security laws and regulations. The department shall establish
   80  policies and procedures as appropriate regarding the reporting,
   81  accessing the database, evaluation, management, development,
   82  implementation, operation, storage, and security of information
   83  within the system. The reporting of prescribed controlled
   84  substances shall include a dispensing transaction with a
   85  dispenser pursuant to chapter 465 or through a dispensing
   86  transaction to an individual or address in this state with a
   87  pharmacy that is not located in this state but that is otherwise
   88  subject to the jurisdiction of this state as to that dispensing
   89  transaction. The reporting of patient advisory reports refers
   90  only to reports to patients, pharmacies, and practitioners.
   91  Separate reports that contain patient prescription history
   92  information and that are not patient advisory reports are
   93  provided to persons and entities as authorized in paragraphs
   94  (7)(b) and (c) and s. 893.0551.
   95         (b)1. The department’s prescription drug monitoring program
   96  shall:
   97         a. Provide reports directly to the Department of Law
   98  Enforcement without review by the department or a regulatory
   99  board so that the Department of Law Enforcement may investigate
  100  whether any violation of law has occurred regarding controlled
  101  substances in Schedule II, Schedule III, or Schedule IV; and
  102         b. Report, if applicable, the information to the
  103  appropriate state attorney or other law enforcement agency in
  104  accordance with state law.
  105  
  106  The parameters for such reports shall be adopted by rule of the
  107  department and developed after consultation with the Department
  108  of Law Enforcement, the Florida Medical Association, and the
  109  Florida Osteopathic Medical Association.
  110         2. The department, when the direct support organization
  111  receives at least $20,000 in nonstate moneys or the state
  112  receives at least $20,000 in federal grants for the prescription
  113  drug monitoring program, and in consultation with the Office of
  114  Drug Control, shall adopt rules as necessary concerning the
  115  reporting, accessing the database, evaluation, management,
  116  development, implementation, operation, security, and storage of
  117  information within the system, including rules for when patient
  118  advisory reports are provided to pharmacies and prescribers. The
  119  patient advisory report shall be provided in accordance with s.
  120  893.13(7)(a)8. The department shall work with the professional
  121  health care licensure boards, such as the Board of Medicine, the
  122  Board of Osteopathic Medicine, and the Board of Pharmacy; other
  123  appropriate organizations, such as the Florida Pharmacy
  124  Association, the Office of Drug Control, the Florida Medical
  125  Association, the Florida Retail Federation, and the Florida
  126  Osteopathic Medical Association, including those relating to
  127  pain management; and the Attorney General, the Department of Law
  128  Enforcement, and the Agency for Health Care Administration to
  129  develop rules appropriate for the prescription drug monitoring
  130  program.
  131         (c) All dispensers and prescribers subject to these
  132  reporting requirements shall be notified by the department of
  133  the implementation date for such reporting requirements.
  134         (d) The department shall establish a method to allow
  135  corrections to the database when notified by a health care
  136  practitioner or pharmacist.
  137         (3) The pharmacy dispensing the controlled substance and
  138  each prescriber who directly dispenses a controlled substance
  139  shall submit to the electronic system, by a procedure and in a
  140  format established by the department and consistent with an
  141  ASAP-approved format, the following information for inclusion in
  142  the database:
  143         (a) The name of the prescribing practitioner, the
  144  practitioner’s federal Drug Enforcement Administration
  145  registration number, the practitioner’s National Provider
  146  Identification (NPI) or other appropriate identifier, and the
  147  date of the prescription.
  148         (b) The date the prescription was filled and the method of
  149  payment, such as cash by an individual, insurance coverage
  150  through a third party, or Medicaid payment. This paragraph does
  151  not authorize the department to include individual credit card
  152  numbers or other account numbers in the database.
  153         (c) The full name, address, and date of birth of the person
  154  for whom the prescription was written.
  155         (d) The name, national drug code, quantity, and strength of
  156  the controlled substance dispensed.
  157         (e) The full name, federal Drug Enforcement Administration
  158  registration number, and address of the pharmacy or other
  159  location from which the controlled substance was dispensed. If
  160  the controlled substance was dispensed by a practitioner other
  161  than a pharmacist, the practitioner’s full name, federal Drug
  162  Enforcement Administration registration number, and address.
  163         (f) The name of the pharmacy or practitioner, other than a
  164  pharmacist, dispensing the controlled substance and the
  165  practitioner’s National Provider Identification (NPI).
  166         (g) Other appropriate identifying information as determined
  167  by department rule.
  168         (h) The number of refills ordered and whether the drug was
  169  dispensed as a refill of a prescription or was a first-time
  170  request.
  171         (5) When the following acts of dispensing or administering
  172  occur, the following are exempt from reporting under this
  173  section for that specific act of dispensing or administration:
  174         (a) A health care practitioner when administering a
  175  controlled substance directly to a patient if the amount of the
  176  controlled substance is adequate to treat the patient during
  177  that particular treatment session.
  178         (b) A pharmacist or health care practitioner when
  179  administering a controlled substance to a patient or resident
  180  receiving care as a patient at a hospital, nursing home,
  181  ambulatory surgical center, hospice, or intermediate care
  182  facility for the developmentally disabled which is licensed in
  183  this state.
  184         (c)A practitioner when administering or dispensing a
  185  controlled substance in the health care system of the Department
  186  of Corrections.
  187         (c)(d) A practitioner when administering a controlled
  188  substance in the emergency room of a licensed hospital.
  189         (d)(e) A health care practitioner when administering or
  190  dispensing a controlled substance directly to a patient person
  191  under the age of 16 if the amount of the controlled substance is
  192  adequate to treat the patient during that particular treatment
  193  session.
  194         (e)(f) A pharmacist or a dispensing practitioner when
  195  dispensing a one-time, 48-hour 72-hour emergency resupply of a
  196  controlled substance to a patient.
  197         (7)(a) A practitioner or pharmacist who dispenses a
  198  controlled substance must submit the information required by
  199  this section in an electronic or other method in an ASAP format
  200  approved by rule of the department unless otherwise provided in
  201  this section. The cost to the dispenser in submitting the
  202  information required by this section may not be material or
  203  extraordinary. Costs not considered to be material or
  204  extraordinary include, but are not limited to, regular postage,
  205  electronic media, regular electronic mail, and facsimile
  206  charges.
  207         (b)1.In order for a pharmacy, prescriber, practitioner, or
  208  dispenser to shall have access to information in the
  209  prescription drug monitoring program’s database which relates to
  210  a patient of that pharmacy, prescriber, practitioner, or
  211  dispenser, the pharmacy, prescriber, practitioner, or dispenser
  212  shall register with the department by submitting a registration
  213  document provided by the department in a manner established by
  214  the department as needed for the purpose of reviewing the
  215  patient’s controlled substance prescription history. The
  216  registration document must be notarized before it is submitted
  217  to the department. Before a pharmacy, prescriber, practitioner,
  218  or dispenser is granted access to information in the
  219  prescription drug monitoring program’s database, the submitted
  220  document must be approved by the department. Upon approval, the
  221  department shall grant the registrant access to the appropriate
  222  information in the prescription drug monitoring program’s
  223  database.
  224         2. Other access to the program’s database shall be limited
  225  to the program program’s manager and to the designated program
  226  and support staff, who may act only at the direction of the
  227  program manager or, in the absence of the program manager, as
  228  authorized. Access by the program manager or such designated
  229  staff is for prescription drug program management only or for
  230  management of the program’s database and its system in support
  231  of the requirements of this section and in furtherance of the
  232  prescription drug monitoring program. Confidential and exempt
  233  information in the database shall be released only as provided
  234  in paragraph (c) and s. 893.0551. The program manager,
  235  designated program and support staff who act at the direction of
  236  or in the absence of the program manager, and any individual who
  237  has similar access regarding the management of the prescription
  238  drug monitoring program database must submit fingerprints to the
  239  department for background screening. The department shall follow
  240  the procedure established by the Department of Law Enforcement
  241  to request a statewide criminal history record check and to
  242  request that the Department of Law Enforcement forward the
  243  fingerprints to the Federal Bureau of Investigation for a
  244  national criminal history record check.
  245         (c) Except as provided in subparagraph (2)(b)1., the
  246  following entities shall not be allowed direct access to
  247  information in the prescription drug monitoring program database
  248  but may request from the program manager and, when authorized by
  249  the program manager, the program manager’s program and support
  250  staff, information that is confidential and exempt under s.
  251  893.0551. Prior to release, the request shall be verified as
  252  authentic and authorized with the requesting organization by the
  253  program manager, the program manager’s program and support
  254  staff, or as determined in rules by the department as being
  255  authentic and as having been authorized by the requesting
  256  entity:
  257         1. The department or its relevant health care regulatory
  258  boards responsible for the licensure, regulation, or discipline
  259  of practitioners, pharmacists, or other persons who are
  260  authorized to prescribe, administer, or dispense controlled
  261  substances and who are involved in a specific controlled
  262  substance investigation involving a designated person for one or
  263  more prescribed controlled substances.
  264         2. The Attorney General or the Agency for Health Care
  265  Administration for Medicaid fraud cases or Medicaid
  266  investigations involving prescribed controlled substances.
  267         3. A law enforcement agency during active investigations
  268  regarding potential criminal activity, fraud, or theft regarding
  269  prescribed controlled substances.
  270         4. A patient or the legal guardian or designated health
  271  care surrogate of an incapacitated patient as described in s.
  272  893.0551 who, for the purpose of verifying the accuracy of the
  273  database information, submits a written and notarized request
  274  that includes the patient’s full name, address, and date of
  275  birth, and includes the same information if the legal guardian
  276  or health care surrogate submits the request. The patient’s
  277  phone number and a copy of a government-issued photo
  278  identification must be provided in person to the program manager
  279  along with the notarized request. The request shall be validated
  280  by the department to verify the identity of the patient and the
  281  legal guardian or health care surrogate, if the patient’s legal
  282  guardian or health care surrogate is the requestor. Such
  283  verification is also required for any request to change a
  284  patient’s prescription history or other information related to
  285  his or her information in the electronic database.
  286  
  287  Information in the database for the electronic prescription drug
  288  monitoring system is not discoverable or admissible in any civil
  289  or administrative action, except in an investigation and
  290  disciplinary proceeding by the department or the appropriate
  291  regulatory board.
  292         (d) The following entities shall not be allowed direct
  293  access to information in the prescription drug monitoring
  294  program database but may request from the program manager and,
  295  when authorized by the program manager, the program manager’s
  296  program and support staff, information that contains no
  297  identifying information of any patient, physician, health care
  298  practitioner, prescriber, or dispenser and that is not
  299  confidential and exempt:
  300         1. Department staff for the purpose of calculating
  301  performance measures pursuant to subsection (8).
  302         2. The Program Implementation and Oversight Task Force for
  303  its reporting to the Governor, the President of the Senate, and
  304  the Speaker of the House of Representatives regarding the
  305  prescription drug monitoring program. This subparagraph expires
  306  July 1, 2012.
  307         (e) All transmissions of data required by this section must
  308  comply with relevant state and federal privacy and security laws
  309  and regulations. However, any authorized agency or person under
  310  s. 893.0551 receiving such information as allowed by s. 893.0551
  311  may maintain the information received for up to 24 months before
  312  purging it from his or her records or maintain it for longer
  313  than 24 months if the information is pertinent to ongoing health
  314  care or an active law enforcement investigation or prosecution.
  315         (8)After the prescription drug monitoring system has been
  316  operational for 18 months, the State Surgeon General shall enter
  317  into reciprocal agreements for the sharing of prescription drug
  318  monitoring information with any other state or states that have
  319  compatible prescription drug monitoring programs. If the State
  320  Surgeon General evaluates the prescription drug monitoring
  321  program of another state as authorized in this subsection,
  322  priority shall be given to a state that is contiguous with the
  323  borders of this state.
  324         (a)In determining compatibility, the State Surgeon General
  325  shall consider:
  326         1.The essential purposes of the program and the success of
  327  the program in fulfilling those purposes.
  328         2.The safeguards for privacy of patient records and the
  329  success of the program in protecting patient privacy.
  330         3.The persons authorized to view the data collected by the
  331  program.
  332         4.The schedules of the controlled substances monitored.
  333         5.The data required to be submitted on each prescription.
  334         6.Any implementation criteria deemed essential for a
  335  thorough comparison.
  336         (b)The State Surgeon General shall review any agreement on
  337  an annual basis to determine its continued compatibility with
  338  the prescription drug monitoring program in this state.
  339         (c)Any agreement between the State Surgeon General and
  340  another state shall prohibit the sharing of information about a
  341  resident of this state or a practitioner, pharmacist, or other
  342  prescriber for any purposes not otherwise authorized by this
  343  section or s. 893.0551.
  344         Section 2. Present subsections (4), (5), and (6) of section
  345  893.0551, Florida Statutes, are renumbered as subsections (5),
  346  (6), and (7), respectively, and a new subsection (4) is added to
  347  that section, to read:
  348         893.0551 Public records exemption for the prescription drug
  349  monitoring program.—
  350         (4) The department may disclose confidential and exempt
  351  information contained in records held by the department under s.
  352  893.055 if the State Surgeon General has entered into a
  353  reciprocal agreement for the sharing of prescription drug
  354  monitoring information with any other state that has compatible
  355  prescription drug monitoring programs, as provided under s.
  356  893.055(8).
  357         Section 3. This act shall take effect July 1, 2010.

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