Bill Text: FL S7038 | 2016 | Regular Session | Prefiled

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Controlled Substances

Spectrum: Committee Bill

Status: (Failed) 2016-03-11 - Died in Appropriations Subcommittee on Health and Human Services, companion bill(s) passed, see CS/CS/SB 964 (Ch. 2016-177) [S7038 Detail]

Download: Florida-2016-S7038-Prefiled.html

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       Florida Senate - 2016                   (PROPOSED BILL) SPB 7038
       
       
        
       FOR CONSIDERATION By the Committee on Health Policy
       
       588-01843A-16                                         20167038pb
    1                        A bill to be entitled                      
    2         An act relating to controlled substances; amending s.
    3         456.42, F.S.; authorizing certain controlled
    4         substances to be electronically prescribed; amending
    5         s. 499.0121, F.S.; deleting a specified requirement in
    6         the performance of due diligence of purchasers by
    7         prescription drug wholesalers; amending s. 893.055,
    8         F.S.; authorizing the designee of a pharmacy,
    9         prescriber, or dispenser to access a patient’s record
   10         in the prescription drug monitoring program’s database
   11         for a specified purpose; authorizing an impaired
   12         practitioner consultant to access an impaired
   13         practitioner program participant’s or referral’s
   14         record in the prescription drug monitoring program’s
   15         database; reenacting and amending s. 893.0551, F.S.;
   16         authorizing the designee of a health care
   17         practitioner, pharmacist, pharmacy, prescriber, or
   18         dispenser and an impaired practitioner consultant to
   19         receive certain information from the prescription drug
   20         monitoring program; providing an effective date.
   21          
   22  Be It Enacted by the Legislature of the State of Florida:
   23  
   24         Section 1. Subsection (2) of section 456.42, Florida
   25  Statutes, is amended to read:
   26         456.42 Written prescriptions for medicinal drugs.—
   27         (2) A written prescription for a controlled substance
   28  listed in chapter 893 must have the quantity of the drug
   29  prescribed in both textual and numerical formats, must be dated
   30  in numerical, month/day/year format, or with the abbreviated
   31  month written out, or the month written out in whole, and must
   32  be either written on a standardized counterfeit-proof
   33  prescription pad produced by a vendor approved by the department
   34  or electronically prescribed as that term is used in s.
   35  408.0611. All controlled substances listed in Schedule II,
   36  Schedule III, Schedule IV, and Schedule V may be electronically
   37  prescribed pursuant to applicable federal law. As a condition of
   38  being an approved vendor, a prescription pad vendor must submit
   39  a monthly report to the department that, at a minimum, documents
   40  the number of prescription pads sold and identifies the
   41  purchasers. The department may, by rule, require the reporting
   42  of additional information.
   43         Section 2. Paragraph (b) of subsection (15) of section
   44  499.0121, Florida Statutes, is amended to read:
   45         499.0121 Storage and handling of prescription drugs;
   46  recordkeeping.—The department shall adopt rules to implement
   47  this section as necessary to protect the public health, safety,
   48  and welfare. Such rules shall include, but not be limited to,
   49  requirements for the storage and handling of prescription drugs
   50  and for the establishment and maintenance of prescription drug
   51  distribution records.
   52         (15) DUE DILIGENCE OF PURCHASERS.—
   53         (b) A wholesale distributor must take reasonable measures
   54  to identify its customers, understand the normal and expected
   55  transactions conducted by those customers, and identify those
   56  transactions that are suspicious in nature. A wholesale
   57  distributor must establish internal policies and procedures for
   58  identifying suspicious orders and preventing suspicious
   59  transactions. A wholesale distributor must assess orders for
   60  greater than 5,000 unit doses of any one controlled substance in
   61  any one month to determine whether the purchase is reasonable.
   62  In making such assessments, a wholesale distributor may consider
   63  the purchasing entity’s clinical business needs, location, and
   64  population served, in addition to other factors established in
   65  the distributor’s policies and procedures. A wholesale
   66  distributor must report to the department any regulated
   67  transaction involving an extraordinary quantity of a listed
   68  chemical, an uncommon method of payment or delivery, or any
   69  other circumstance that the regulated person believes may
   70  indicate that the listed chemical will be used in violation of
   71  the law. The wholesale distributor shall maintain records that
   72  document the report submitted to the department in compliance
   73  with this paragraph.
   74         Section 3. Paragraphs (b) and (c) of subsection (7) and
   75  subsection (12) of section 893.055, Florida Statutes, are
   76  amended to read:
   77         893.055 Prescription drug monitoring program.—
   78         (7)
   79         (b) A pharmacy, prescriber, or dispenser, or the designee
   80  of a pharmacy, prescriber, or dispenser, shall have access to
   81  information in the prescription drug monitoring program’s
   82  database which relates to a patient of that pharmacy,
   83  prescriber, or dispenser in a manner established by the
   84  department as needed for the purpose of reviewing the patient’s
   85  controlled substance prescription history. Other access to the
   86  program’s database shall be limited to the program’s manager and
   87  to the designated program and support staff, who may act only at
   88  the direction of the program manager or, in the absence of the
   89  program manager, as authorized. Access by the program manager or
   90  such designated staff is for prescription drug program
   91  management only or for management of the program’s database and
   92  its system in support of the requirements of this section and in
   93  furtherance of the prescription drug monitoring program.
   94  Confidential and exempt information in the database shall be
   95  released only as provided in paragraph (c) and s. 893.0551. The
   96  program manager, designated program and support staff who act at
   97  the direction of or in the absence of the program manager, and
   98  any individual who has similar access regarding the management
   99  of the database from the prescription drug monitoring program
  100  shall submit fingerprints to the department for background
  101  screening. The department shall follow the procedure established
  102  by the Department of Law Enforcement to request a statewide
  103  criminal history record check and to request that the Department
  104  of Law Enforcement forward the fingerprints to the Federal
  105  Bureau of Investigation for a national criminal history record
  106  check.
  107         (c) The following entities are shall not be allowed direct
  108  access to information in the prescription drug monitoring
  109  program database but may request from the program manager and,
  110  when authorized by the program manager, the program manager’s
  111  program and support staff, information that is confidential and
  112  exempt under s. 893.0551. Before Prior to release, a the request
  113  by the following entities shall be verified as authentic and
  114  authorized with the requesting organization by the program
  115  manager, the program manager’s program and support staff, or as
  116  determined in rules by the department as being authentic and as
  117  having been authorized by the requesting entity:
  118         1. The department or its relevant health care regulatory
  119  boards responsible for the licensure, regulation, or discipline
  120  of practitioners, pharmacists, or other persons who are
  121  authorized to prescribe, administer, or dispense controlled
  122  substances and who are involved in a specific controlled
  123  substance investigation involving a designated person for one or
  124  more prescribed controlled substances.
  125         2. The Attorney General for Medicaid fraud cases involving
  126  prescribed controlled substances.
  127         3. A law enforcement agency during active investigations of
  128  regarding potential criminal activity, fraud, or theft regarding
  129  prescribed controlled substances.
  130         4. A patient or the legal guardian or designated health
  131  care surrogate of an incapacitated patient as described in s.
  132  893.0551 who, for the purpose of verifying the accuracy of the
  133  database information, submits a written and notarized request
  134  that includes the patient’s full name, address, and date of
  135  birth, and includes the same information if the legal guardian
  136  or health care surrogate submits the request. The request shall
  137  be validated by the department to verify the identity of the
  138  patient and the legal guardian or health care surrogate, if the
  139  patient’s legal guardian or health care surrogate is the
  140  requestor. Such verification is also required for any request to
  141  change a patient’s prescription history or other information
  142  related to his or her information in the electronic database.
  143         5. An impaired practitioner consultant who is retained by
  144  the department under s. 456.076 for the purpose of reviewing the
  145  database information of an impaired practitioner program
  146  participant or a referral who has agreed to be evaluated or
  147  monitored through the program and who has separately agreed in
  148  writing to the consultant’s access to and review of such
  149  information.
  150  
  151  Information in the database for the electronic prescription drug
  152  monitoring system is not discoverable or admissible in any civil
  153  or administrative action, except in an investigation and
  154  disciplinary proceeding by the department or the appropriate
  155  regulatory board.
  156         (12) A prescriber or dispenser, or his or her designee, may
  157  have access to the information under this section which relates
  158  to a patient of that prescriber or dispenser as needed for the
  159  purpose of reviewing the patient’s controlled drug prescription
  160  history. A prescriber or dispenser acting in good faith is
  161  immune from any civil, criminal, or administrative liability
  162  that might otherwise be incurred or imposed for receiving or
  163  using information from the prescription drug monitoring program.
  164  This subsection does not create a private cause of action, and a
  165  person may not recover damages against a prescriber or dispenser
  166  authorized to access information under this subsection for
  167  accessing or failing to access such information.
  168         Section 4. Section 893.0551, Florida Statutes, is reenacted
  169  and amended to read:
  170         893.0551 Public records exemption for the prescription drug
  171  monitoring program.—
  172         (1) For purposes of this section, the terms used in this
  173  section have the same meanings as provided in s. 893.055.
  174         (2) The following information of a patient or patient’s
  175  agent, a health care practitioner, a dispenser, an employee of
  176  the practitioner who is acting on behalf of and at the direction
  177  of the practitioner, a pharmacist, or a pharmacy that is
  178  contained in records held by the department under s. 893.055 is
  179  confidential and exempt from s. 119.07(1) and s. 24(a), Art. I
  180  of the State Constitution:
  181         (a) Name.
  182         (b) Address.
  183         (c) Telephone number.
  184         (d) Insurance plan number.
  185         (e) Government-issued identification number.
  186         (f) Provider number.
  187         (g) Drug Enforcement Administration number.
  188         (h) Any other unique identifying information or number.
  189         (3) The department shall disclose such confidential and
  190  exempt information to the following persons or entities upon
  191  request and after using a verification process to ensure the
  192  legitimacy of the request as provided in s. 893.055:
  193         (a) The Attorney General, or his or her designee, when
  194  working on Medicaid fraud cases involving prescription drugs or
  195  when the Attorney General has initiated a review of specific
  196  identifiers of Medicaid fraud regarding prescription drugs. The
  197  Attorney General’s Medicaid fraud investigators may not have
  198  direct access to the department’s database. The Attorney
  199  General, or his or her designee, may disclose to a criminal
  200  justice agency, as defined in s. 119.011, only the confidential
  201  and exempt information received from the department that is
  202  relevant to an identified active investigation that prompted the
  203  request for the information.
  204         (b) The department’s relevant health care regulatory boards
  205  responsible for the licensure, regulation, or discipline of a
  206  practitioner, pharmacist, or other person who is authorized to
  207  prescribe, administer, or dispense controlled substances and who
  208  is involved in a specific controlled substances investigation
  209  for prescription drugs involving a designated person. The health
  210  care regulatory boards may request information from the
  211  department but may not have direct access to its database. The
  212  health care regulatory boards may provide to a law enforcement
  213  agency pursuant to ss. 456.066 and 456.073 only information that
  214  is relevant to the specific controlled substances investigation
  215  that prompted the request for the information.
  216         (c) A law enforcement agency that has initiated an active
  217  investigation involving a specific violation of law regarding
  218  prescription drug abuse or diversion of prescribed controlled
  219  substances and that has entered into a user agreement with the
  220  department. A law enforcement agency may request information
  221  from the department but may not have direct access to its
  222  database. The law enforcement agency may disclose to a criminal
  223  justice agency, as defined in s. 119.011, only confidential and
  224  exempt information received from the department that is relevant
  225  to an identified active investigation that prompted the request
  226  for such information.
  227         (d) A health care practitioner, or his or her designee, who
  228  certifies that the information is necessary to provide medical
  229  treatment to a current patient in accordance with ss. 893.05 and
  230  893.055.
  231         (e) A pharmacist, or his or her designee, who certifies
  232  that the requested information will be used to dispense
  233  controlled substances to a current patient in accordance with
  234  ss. 893.04 and 893.055.
  235         (f) A patient or the legal guardian or designated health
  236  care surrogate for an incapacitated patient, if applicable,
  237  making a request as provided in s. 893.055(7)(c)4.
  238         (g) The patient’s pharmacy, prescriber, or dispenser, or
  239  the designee of the pharmacy, prescriber, or dispenser, who
  240  certifies that the information is necessary to provide medical
  241  treatment to his or her current patient in accordance with s.
  242  893.055.
  243         (h) An impaired practitioner consultant who has been
  244  authorized in writing by a participant in or referral to the
  245  impaired practitioner program to access and review information
  246  as provided in s. 893.055(7)(c)5.
  247         (4) If the department determines consistent with its rules
  248  that a pattern of controlled substance abuse exists, the
  249  department may disclose such confidential and exempt information
  250  to the applicable law enforcement agency in accordance with s.
  251  893.055. The law enforcement agency may disclose to a criminal
  252  justice agency, as defined in s. 119.011, only confidential and
  253  exempt information received from the department that is relevant
  254  to an identified active investigation that is specific to a
  255  violation of s. 893.13(7)(a)8., s. 893.13(8)(a), or s.
  256  893.13(8)(b).
  257         (5) Before disclosing confidential and exempt information
  258  to a criminal justice agency or a law enforcement agency
  259  pursuant to this section, the disclosing person or entity must
  260  take steps to ensure the continued confidentiality of all
  261  confidential and exempt information. At a minimum, these steps
  262  must include redacting any nonrelevant information.
  263         (6) An agency or person who obtains any confidential and
  264  exempt information pursuant to this section must maintain the
  265  confidential and exempt status of that information and may not
  266  disclose such information unless authorized by law. Information
  267  shared with a state attorney pursuant to paragraph (3)(a) or
  268  paragraph (3)(c) may be released only in response to a discovery
  269  demand if such information is directly related to the criminal
  270  case for which the information was requested. Unrelated
  271  information may be released only upon an order of a court of
  272  competent jurisdiction.
  273         (7) A person who willfully and knowingly violates this
  274  section commits a felony of the third degree, punishable as
  275  provided in s. 775.082, s. 775.083, or s. 775.084.
  276         Section 5. This act shall take effect upon becoming a law.