Florida Senate - 2019                                    SB 1192
       
       
        
       By Senator Bean
       
       
       
       
       
       4-01299-19                                            20191192__
    1                        A bill to be entitled                      
    2         An act relating to electronic prescribing; amending s.
    3         456.42, F.S.; requiring all prescriptions to be
    4         electronically generated and transmitted upon a
    5         certain practitioner’s license renewal or by a
    6         specified date; prohibiting electronic prescribing
    7         from interfering with a patient’s freedom to choose a
    8         pharmacy; providing restrictions for electronic
    9         prescribing software; providing definitions;
   10         authorizing electronic prescribing software to display
   11         information regarding a payor’s formulary under
   12         certain circumstances; amending ss. 409.91196,
   13         409.912, 456.0392, 458.3265, 458.331, 458.347,
   14         459.0137, 459.015, and 459.022, F.S.; conforming
   15         provisions to changes made by the act; repealing ss.
   16         456.43, 831.311, and 893.065, F.S., relating to
   17         electronic prescribing for medicinal drugs, the
   18         unlawful sale, manufacture, alteration, delivery,
   19         uttering, or possession of counterfeit-resistant
   20         prescription blanks for controlled substances, and
   21         counterfeit-resistant prescription blanks for
   22         controlled substances listed in Schedule II, Schedule
   23         III, Schedule IV, or Schedule V, respectively;
   24         providing an effective date.
   25          
   26  Be It Enacted by the Legislature of the State of Florida:
   27  
   28         Section 1. Section 456.42, Florida Statutes, is amended to
   29  read:
   30         456.42 Written Prescriptions for medicinal drugs.—
   31         (1) Upon renewal of the health care practitioner’s license
   32  or by July 1, 2021, whichever is earlier, a written prescription
   33  for a medicinal drug issued by a health care practitioner
   34  licensed by law to prescribe a medicinal such drug may only
   35  electronically transmit prescriptions for such drugs must be
   36  legibly printed or typed so as to be capable of being understood
   37  by the pharmacist filling the prescription; must contain the
   38  name of the prescribing practitioner, the name and strength of
   39  the drug prescribed, the quantity of the drug prescribed, and
   40  the directions for use of the drug; must be dated; and must be
   41  signed by the prescribing practitioner on the day when issued.
   42  However, A prescription that is electronically generated and
   43  transmitted must contain the name of the prescribing
   44  practitioner, the name and strength of the drug prescribed, the
   45  quantity of the drug prescribed in numerical format, and the
   46  directions for use of the drug and must contain the date and an
   47  electronic signature, as defined in s. 668.003(4), be dated and
   48  signed by the prescribing practitioner only on the day issued,
   49  which signature may be in an electronic format as defined in s.
   50  668.003(4).
   51         (2)Electronic prescribing may not interfere with a
   52  patient’s freedom to choose a pharmacy.
   53         (3)Electronic prescribing software may not use any means
   54  or permit any other person to use any means, including, but not
   55  limited to, advertising, instant messaging, and pop-up ads, to
   56  influence or attempt to influence through economic incentives or
   57  otherwise the prescribing decision of a prescribing practitioner
   58  or his or her agent at the point of care. Such means may not be
   59  triggered by or in specific response to the input, selection, or
   60  act of a prescribing practitioner or his or her agent in
   61  prescribing a certain medicinal drug or directing a patient to a
   62  certain pharmacy. For purposes of this subsection, the term:
   63         (a)“Point of care” means the time at which a prescribing
   64  practitioner or his or her agent prescribes any medicinal drug.
   65         (b)“Prescribing decision” means a prescribing
   66  practitioner’s or his or her agent’s decision to prescribe any
   67  medicinal drug.
   68         (4)Electronic prescribing software may display information
   69  regarding a payor’s formulary if nothing is designed to preclude
   70  or make more difficult the selection of any particular pharmacy
   71  by a patient or the selection of a certain medicinal drug by a
   72  prescribing practitioner or his or her agent.
   73         (2)A written prescription for a controlled substance
   74  listed in chapter 893 must have the quantity of the drug
   75  prescribed in both textual and numerical formats, must be dated
   76  in numerical, month/day/year format, or with the abbreviated
   77  month written out, or the month written out in whole, and must
   78  be either written on a standardized counterfeit-proof
   79  prescription pad produced by a vendor approved by the department
   80  or electronically prescribed as that term is used in s.
   81  408.0611. As a condition of being an approved vendor, a
   82  prescription pad vendor must submit a monthly report to the
   83  department that, at a minimum, documents the number of
   84  prescription pads sold and identifies the purchasers. The
   85  department may, by rule, require the reporting of additional
   86  information.
   87         Section 2. Subsection (1) of section 409.91196, Florida
   88  Statutes, is amended to read:
   89         409.91196 Supplemental rebate agreements; public records
   90  and public meetings exemption.—
   91         (1) The rebate amount, percent of rebate, manufacturer’s
   92  pricing, and supplemental rebate, and other trade secrets as
   93  defined in s. 688.002 that the agency has identified for use in
   94  negotiations, held by the Agency for Health Care Administration
   95  under s. 409.912(5)(a)6. s. 409.912(5)(a)7. are confidential and
   96  exempt from s. 119.07(1) and s. 24(a), Art. I of the State
   97  Constitution.
   98         Section 3. Paragraph (a) of subsection (5) of section
   99  409.912, Florida Statutes, is amended to read:
  100         409.912 Cost-effective purchasing of health care.—The
  101  agency shall purchase goods and services for Medicaid recipients
  102  in the most cost-effective manner consistent with the delivery
  103  of quality medical care. To ensure that medical services are
  104  effectively utilized, the agency may, in any case, require a
  105  confirmation or second physician’s opinion of the correct
  106  diagnosis for purposes of authorizing future services under the
  107  Medicaid program. This section does not restrict access to
  108  emergency services or poststabilization care services as defined
  109  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
  110  shall be rendered in a manner approved by the agency. The agency
  111  shall maximize the use of prepaid per capita and prepaid
  112  aggregate fixed-sum basis services when appropriate and other
  113  alternative service delivery and reimbursement methodologies,
  114  including competitive bidding pursuant to s. 287.057, designed
  115  to facilitate the cost-effective purchase of a case-managed
  116  continuum of care. The agency shall also require providers to
  117  minimize the exposure of recipients to the need for acute
  118  inpatient, custodial, and other institutional care and the
  119  inappropriate or unnecessary use of high-cost services. The
  120  agency shall contract with a vendor to monitor and evaluate the
  121  clinical practice patterns of providers in order to identify
  122  trends that are outside the normal practice patterns of a
  123  provider’s professional peers or the national guidelines of a
  124  provider’s professional association. The vendor must be able to
  125  provide information and counseling to a provider whose practice
  126  patterns are outside the norms, in consultation with the agency,
  127  to improve patient care and reduce inappropriate utilization.
  128  The agency may mandate prior authorization, drug therapy
  129  management, or disease management participation for certain
  130  populations of Medicaid beneficiaries, certain drug classes, or
  131  particular drugs to prevent fraud, abuse, overuse, and possible
  132  dangerous drug interactions. The Pharmaceutical and Therapeutics
  133  Committee shall make recommendations to the agency on drugs for
  134  which prior authorization is required. The agency shall inform
  135  the Pharmaceutical and Therapeutics Committee of its decisions
  136  regarding drugs subject to prior authorization. The agency is
  137  authorized to limit the entities it contracts with or enrolls as
  138  Medicaid providers by developing a provider network through
  139  provider credentialing. The agency may competitively bid single
  140  source-provider contracts if procurement of goods or services
  141  results in demonstrated cost savings to the state without
  142  limiting access to care. The agency may limit its network based
  143  on the assessment of beneficiary access to care, provider
  144  availability, provider quality standards, time and distance
  145  standards for access to care, the cultural competence of the
  146  provider network, demographic characteristics of Medicaid
  147  beneficiaries, practice and provider-to-beneficiary standards,
  148  appointment wait times, beneficiary use of services, provider
  149  turnover, provider profiling, provider licensure history,
  150  previous program integrity investigations and findings, peer
  151  review, provider Medicaid policy and billing compliance records,
  152  clinical and medical record audits, and other factors. Providers
  153  are not entitled to enrollment in the Medicaid provider network.
  154  The agency shall determine instances in which allowing Medicaid
  155  beneficiaries to purchase durable medical equipment and other
  156  goods is less expensive to the Medicaid program than long-term
  157  rental of the equipment or goods. The agency may establish rules
  158  to facilitate purchases in lieu of long-term rentals in order to
  159  protect against fraud and abuse in the Medicaid program as
  160  defined in s. 409.913. The agency may seek federal waivers
  161  necessary to administer these policies.
  162         (5)(a) The agency shall implement a Medicaid prescribed
  163  drug spending-control program that includes the following
  164  components:
  165         1. A Medicaid preferred drug list, which shall be a listing
  166  of cost-effective therapeutic options recommended by the
  167  Medicaid Pharmacy and Therapeutics Committee established
  168  pursuant to s. 409.91195 and adopted by the agency for each
  169  therapeutic class on the preferred drug list. At the discretion
  170  of the committee, and when feasible, the preferred drug list
  171  should include at least two products in a therapeutic class. The
  172  agency may post the preferred drug list and updates to the list
  173  on an Internet website without following the rulemaking
  174  procedures of chapter 120. Antiretroviral agents are excluded
  175  from the preferred drug list. The agency shall also limit the
  176  amount of a prescribed drug dispensed to no more than a 34-day
  177  supply unless the drug products’ smallest marketed package is
  178  greater than a 34-day supply, or the drug is determined by the
  179  agency to be a maintenance drug in which case a 100-day maximum
  180  supply may be authorized. The agency may seek any federal
  181  waivers necessary to implement these cost-control programs and
  182  to continue participation in the federal Medicaid rebate
  183  program, or alternatively to negotiate state-only manufacturer
  184  rebates. The agency may adopt rules to administer this
  185  subparagraph. The agency shall continue to provide unlimited
  186  contraceptive drugs and items. The agency must establish
  187  procedures to ensure that:
  188         a. There is a response to a request for prior consultation
  189  by telephone or other telecommunication device within 24 hours
  190  after receipt of a request for prior consultation; and
  191         b. A 72-hour supply of the drug prescribed is provided in
  192  an emergency or when the agency does not provide a response
  193  within 24 hours as required by sub-subparagraph a.
  194         2. Reimbursement to pharmacies for Medicaid prescribed
  195  drugs shall be set at the lowest of: the average wholesale price
  196  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
  197  plus 1.5 percent, the federal upper limit (FUL), the state
  198  maximum allowable cost (SMAC), or the usual and customary (UAC)
  199  charge billed by the provider.
  200         3. The agency shall develop and implement a process for
  201  managing the drug therapies of Medicaid recipients who are using
  202  significant numbers of prescribed drugs each month. The
  203  management process may include, but is not limited to,
  204  comprehensive, physician-directed medical-record reviews, claims
  205  analyses, and case evaluations to determine the medical
  206  necessity and appropriateness of a patient’s treatment plan and
  207  drug therapies. The agency may contract with a private
  208  organization to provide drug-program-management services. The
  209  Medicaid drug benefit management program shall include
  210  initiatives to manage drug therapies for HIV/AIDS patients,
  211  patients using 20 or more unique prescriptions in a 180-day
  212  period, and the top 1,000 patients in annual spending. The
  213  agency shall enroll any Medicaid recipient in the drug benefit
  214  management program if he or she meets the specifications of this
  215  subparagraph provision and is not enrolled in a Medicaid health
  216  maintenance organization.
  217         4. The agency may limit the size of its pharmacy network
  218  based on need, competitive bidding, price negotiations,
  219  credentialing, or similar criteria. The agency shall give
  220  special consideration to rural areas in determining the size and
  221  location of pharmacies included in the Medicaid pharmacy
  222  network. A pharmacy credentialing process may include criteria
  223  such as a pharmacy’s full-service status, location, size,
  224  patient educational programs, patient consultation, disease
  225  management services, and other characteristics. The agency may
  226  impose a moratorium on Medicaid pharmacy enrollment if it is
  227  determined that it has a sufficient number of Medicaid
  228  participating providers. The agency must allow dispensing
  229  practitioners to participate as a part of the Medicaid pharmacy
  230  network regardless of the practitioner’s proximity to any other
  231  entity that is dispensing prescription drugs under the Medicaid
  232  program. A dispensing practitioner must meet all credentialing
  233  requirements applicable to his or her practice, as determined by
  234  the agency.
  235         5.The agency shall develop and implement a program that
  236  requires Medicaid practitioners who prescribe drugs to use a
  237  counterfeit-proof prescription pad for Medicaid prescriptions.
  238  The agency shall require the use of standardized counterfeit
  239  proof prescription pads by Medicaid-participating prescribers or
  240  prescribers who write prescriptions for Medicaid recipients. The
  241  agency may implement the program in targeted geographic areas or
  242  statewide.
  243         5.6. The agency may enter into arrangements that require
  244  manufacturers of generic drugs prescribed to Medicaid recipients
  245  to provide rebates of at least 15.1 percent of the average
  246  manufacturer price for the manufacturer’s generic products.
  247  These arrangements shall require that if a generic-drug
  248  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  249  at a level below 15.1 percent, the manufacturer must provide a
  250  supplemental rebate to the state in an amount necessary to
  251  achieve a 15.1-percent rebate level.
  252         6.7. The agency may establish a preferred drug list as
  253  described in this subsection, and, pursuant to the establishment
  254  of such preferred drug list, negotiate supplemental rebates from
  255  manufacturers that are in addition to those required by Title
  256  XIX of the Social Security Act and at no less than 14 percent of
  257  the average manufacturer price as defined in 42 U.S.C. s. 1936
  258  on the last day of a quarter unless the federal or supplemental
  259  rebate, or both, equals or exceeds 29 percent. There is no upper
  260  limit on the supplemental rebates the agency may negotiate. The
  261  agency may determine that specific products, brand-name or
  262  generic, are competitive at lower rebate percentages. Agreement
  263  to pay the minimum supplemental rebate percentage guarantees a
  264  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  265  Committee will consider a product for inclusion on the preferred
  266  drug list. However, a pharmaceutical manufacturer is not
  267  guaranteed placement on the preferred drug list by simply paying
  268  the minimum supplemental rebate. Agency decisions will be made
  269  on the clinical efficacy of a drug and recommendations of the
  270  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  271  the price of competing products minus federal and state rebates.
  272  The agency may contract with an outside agency or contractor to
  273  conduct negotiations for supplemental rebates. For the purposes
  274  of this section, the term “supplemental rebates” means cash
  275  rebates. Value-added programs as a substitution for supplemental
  276  rebates are prohibited. The agency may seek any federal waivers
  277  to implement this initiative.
  278         7.8. The agency shall expand home delivery of pharmacy
  279  products. The agency may amend the state plan and issue a
  280  procurement, as necessary, in order to implement this program.
  281  The procurements must include agreements with a pharmacy or
  282  pharmacies located in the state to provide mail order delivery
  283  services at no cost to the recipients who elect to receive home
  284  delivery of pharmacy products. The procurement must focus on
  285  serving recipients with chronic diseases for which pharmacy
  286  expenditures represent a significant portion of Medicaid
  287  pharmacy expenditures or which impact a significant portion of
  288  the Medicaid population. The agency may seek and implement any
  289  federal waivers necessary to implement this subparagraph.
  290         8.9. The agency shall limit to one dose per month any drug
  291  prescribed to treat erectile dysfunction.
  292         9.a.10.a. The agency may implement a Medicaid behavioral
  293  drug management system. The agency may contract with a vendor
  294  that has experience in operating behavioral drug management
  295  systems to implement this program. The agency may seek federal
  296  waivers to implement this program.
  297         b. The agency, in conjunction with the Department of
  298  Children and Families, may implement the Medicaid behavioral
  299  drug management system that is designed to improve the quality
  300  of care and behavioral health prescribing practices based on
  301  best practice guidelines, improve patient adherence to
  302  medication plans, reduce clinical risk, and lower prescribed
  303  drug costs and the rate of inappropriate spending on Medicaid
  304  behavioral drugs. The program may include the following
  305  elements:
  306         (I) Provide for the development and adoption of best
  307  practice guidelines for behavioral health-related drugs such as
  308  antipsychotics, antidepressants, and medications for treating
  309  bipolar disorders and other behavioral conditions; translate
  310  them into practice; review behavioral health prescribers and
  311  compare their prescribing patterns to a number of indicators
  312  that are based on national standards; and determine deviations
  313  from best practice guidelines.
  314         (II) Implement processes for providing feedback to and
  315  educating prescribers using best practice educational materials
  316  and peer-to-peer consultation.
  317         (III) Assess Medicaid beneficiaries who are outliers in
  318  their use of behavioral health drugs with regard to the numbers
  319  and types of drugs taken, drug dosages, combination drug
  320  therapies, and other indicators of improper use of behavioral
  321  health drugs.
  322         (IV) Alert prescribers to patients who fail to refill
  323  prescriptions in a timely fashion, are prescribed multiple same
  324  class behavioral health drugs, and may have other potential
  325  medication problems.
  326         (V) Track spending trends for behavioral health drugs and
  327  deviation from best practice guidelines.
  328         (VI) Use educational and technological approaches to
  329  promote best practices, educate consumers, and train prescribers
  330  in the use of practice guidelines.
  331         (VII) Disseminate electronic and published materials.
  332         (VIII) Hold statewide and regional conferences.
  333         (IX) Implement a disease management program with a model
  334  quality-based medication component for severely mentally ill
  335  individuals and emotionally disturbed children who are high
  336  users of care.
  337         10.11. The agency shall implement a Medicaid prescription
  338  drug management system.
  339         a. The agency may contract with a vendor that has
  340  experience in operating prescription drug management systems in
  341  order to implement this system. Any management system that is
  342  implemented in accordance with this subparagraph must rely on
  343  cooperation between physicians and pharmacists to determine
  344  appropriate practice patterns and clinical guidelines to improve
  345  the prescribing, dispensing, and use of drugs in the Medicaid
  346  program. The agency may seek federal waivers to implement this
  347  program.
  348         b. The drug management system must be designed to improve
  349  the quality of care and prescribing practices based on best
  350  practice guidelines, improve patient adherence to medication
  351  plans, reduce clinical risk, and lower prescribed drug costs and
  352  the rate of inappropriate spending on Medicaid prescription
  353  drugs. The program must:
  354         (I) Provide for the adoption of best practice guidelines
  355  for the prescribing and use of drugs in the Medicaid program,
  356  including translating best practice guidelines into practice;
  357  reviewing prescriber patterns and comparing them to indicators
  358  that are based on national standards and practice patterns of
  359  clinical peers in their community, statewide, and nationally;
  360  and determine deviations from best practice guidelines.
  361         (II) Implement processes for providing feedback to and
  362  educating prescribers using best practice educational materials
  363  and peer-to-peer consultation.
  364         (III) Assess Medicaid recipients who are outliers in their
  365  use of a single or multiple prescription drugs with regard to
  366  the numbers and types of drugs taken, drug dosages, combination
  367  drug therapies, and other indicators of improper use of
  368  prescription drugs.
  369         (IV) Alert prescribers to recipients who fail to refill
  370  prescriptions in a timely fashion, are prescribed multiple drugs
  371  that may be redundant or contraindicated, or may have other
  372  potential medication problems.
  373         11.12. The agency may contract for drug rebate
  374  administration, including, but not limited to, calculating
  375  rebate amounts, invoicing manufacturers, negotiating disputes
  376  with manufacturers, and maintaining a database of rebate
  377  collections.
  378         12.13. The agency may specify the preferred daily dosing
  379  form or strength for the purpose of promoting best practices
  380  with regard to the prescribing of certain drugs as specified in
  381  the General Appropriations Act and ensuring cost-effective
  382  prescribing practices.
  383         13.14. The agency may require prior authorization for
  384  Medicaid-covered prescribed drugs. The agency may prior
  385  authorize the use of a product:
  386         a. For an indication not approved in labeling;
  387         b. To comply with certain clinical guidelines; or
  388         c. If the product has the potential for overuse, misuse, or
  389  abuse.
  390  
  391  The agency may require the prescribing professional to provide
  392  information about the rationale and supporting medical evidence
  393  for the use of a drug. The agency shall post prior
  394  authorization, step-edit criteria and protocol, and updates to
  395  the list of drugs that are subject to prior authorization on the
  396  agency’s Internet website within 21 days after the prior
  397  authorization and step-edit criteria and protocol and updates
  398  are approved by the agency. For purposes of this subparagraph,
  399  the term “step-edit” means an automatic electronic review of
  400  certain medications subject to prior authorization.
  401         14.15. The agency, in conjunction with the Pharmaceutical
  402  and Therapeutics Committee, may require age-related prior
  403  authorizations for certain prescribed drugs. The agency may
  404  preauthorize the use of a drug for a recipient who may not meet
  405  the age requirement or may exceed the length of therapy for use
  406  of this product as recommended by the manufacturer and approved
  407  by the Food and Drug Administration. Prior authorization may
  408  require the prescribing professional to provide information
  409  about the rationale and supporting medical evidence for the use
  410  of a drug.
  411         15.16. The agency shall implement a step-therapy prior
  412  authorization approval process for medications excluded from the
  413  preferred drug list. Medications listed on the preferred drug
  414  list must be used within the previous 12 months before the
  415  alternative medications that are not listed. The step-therapy
  416  prior authorization may require the prescriber to use the
  417  medications of a similar drug class or for a similar medical
  418  indication unless contraindicated in the Food and Drug
  419  Administration labeling. The trial period between the specified
  420  steps may vary according to the medical indication. The step
  421  therapy approval process shall be developed in accordance with
  422  the committee as stated in s. 409.91195(7) and (8). A drug
  423  product may be approved without meeting the step-therapy prior
  424  authorization criteria if the prescribing physician provides the
  425  agency with additional written medical or clinical documentation
  426  that the product is medically necessary because:
  427         a. There is not a drug on the preferred drug list to treat
  428  the disease or medical condition which is an acceptable clinical
  429  alternative;
  430         b. The alternatives have been ineffective in the treatment
  431  of the beneficiary’s disease; or
  432         c. Based on historic evidence and known characteristics of
  433  the patient and the drug, the drug is likely to be ineffective,
  434  or the number of doses have been ineffective.
  435  
  436  The agency shall work with the physician to determine the best
  437  alternative for the patient. The agency may adopt rules waiving
  438  the requirements for written clinical documentation for specific
  439  drugs in limited clinical situations.
  440         16.17. The agency shall implement a return and reuse
  441  program for drugs dispensed by pharmacies to institutional
  442  recipients, which includes payment of a $5 restocking fee for
  443  the implementation and operation of the program. The return and
  444  reuse program shall be implemented electronically and in a
  445  manner that promotes efficiency. The program must permit a
  446  pharmacy to exclude drugs from the program if it is not
  447  practical or cost-effective for the drug to be included and must
  448  provide for the return to inventory of drugs that cannot be
  449  credited or returned in a cost-effective manner. The agency
  450  shall determine if the program has reduced the amount of
  451  Medicaid prescription drugs which are destroyed on an annual
  452  basis and if there are additional ways to ensure more
  453  prescription drugs are not destroyed which could safely be
  454  reused.
  455         Section 4. Section 456.0392, Florida Statutes, is amended
  456  to read:
  457         456.0392 Prescription labeling.—
  458         (1) A prescription written by a practitioner who is
  459  authorized under the laws of this state to prescribe write
  460  prescriptions for drugs that are not listed as controlled
  461  substances in chapter 893 but who is not eligible for a federal
  462  Drug Enforcement Administration number shall include that
  463  practitioner’s name and professional license number. The
  464  pharmacist or dispensing practitioner must include the
  465  practitioner’s name on the container of the drug that is
  466  dispensed. A pharmacist shall be permitted, upon verification by
  467  the prescriber, to document any information required by this
  468  section.
  469         (2) A prescription for a drug that is not listed as a
  470  controlled substance in chapter 893 which is written by an
  471  advanced practice registered nurse licensed under s. 464.012 is
  472  presumed, subject to rebuttal, to be valid and within the
  473  parameters of the prescriptive authority delegated by a
  474  practitioner licensed under chapter 458, chapter 459, or chapter
  475  466.
  476         (3) A prescription for a drug that is not listed as a
  477  controlled substance in chapter 893 which is written by a
  478  physician assistant licensed under chapter 458 or chapter 459 is
  479  presumed, subject to rebuttal, to be valid and within the
  480  parameters of the prescriptive authority delegated by the
  481  physician assistant’s supervising physician.
  482         Section 5. Paragraph (d) of subsection (3) of section
  483  458.3265, Florida Statutes, is amended to read:
  484         458.3265 Pain-management clinics.—
  485         (3) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  486  apply to any physician who provides professional services in a
  487  pain-management clinic that is required to be registered in
  488  subsection (1).
  489         (d) A physician authorized to prescribe controlled
  490  substances who practices at a pain-management clinic is
  491  responsible for maintaining the control and security of his or
  492  her electronic prescribing software prescription blanks and any
  493  other method used for prescribing controlled substance pain
  494  medication. The physician shall comply with the requirements for
  495  counterfeit-resistant prescription blanks in s. 893.065 and the
  496  rules adopted pursuant to that section. The physician shall
  497  notify, in writing, the department within 24 hours after
  498  following any theft or loss of a prescription blank or breach of
  499  his or her electronic prescribing software any other method for
  500  prescribing pain medication.
  501         Section 6. Paragraph (qq) of subsection (1) of section
  502  458.331, Florida Statutes, is amended to read:
  503         458.331 Grounds for disciplinary action; action by the
  504  board and department.—
  505         (1) The following acts constitute grounds for denial of a
  506  license or disciplinary action, as specified in s. 456.072(2):
  507         (qq) Failing to timely notify the department of the theft
  508  of prescription blanks from a pain-management clinic or a breach
  509  of a physician’s electronic prescribing software other methods
  510  for prescribing within 24 hours as required by s. 458.3265(3).
  511         Section 7. Paragraph (e) of subsection (4) of section
  512  458.347, Florida Statutes, is amended to read:
  513         458.347 Physician assistants.—
  514         (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
  515         (e) A supervising physician may delegate to a fully
  516  licensed physician assistant the authority to prescribe or
  517  dispense any medication used in the supervising physician’s
  518  practice unless such medication is listed on the formulary
  519  created pursuant to paragraph (f). A fully licensed physician
  520  assistant may only prescribe or dispense such medication under
  521  the following circumstances:
  522         1. A physician assistant must clearly identify to the
  523  patient that he or she is a physician assistant and inform the
  524  patient that the patient has the right to see the physician
  525  before a prescription is prescribed or dispensed by the
  526  physician assistant.
  527         2. The supervising physician must notify the department of
  528  his or her intent to delegate, on a department-approved form,
  529  before delegating such authority and of any change in
  530  prescriptive privileges of the physician assistant. Authority to
  531  dispense may be delegated only by a supervising physician who is
  532  registered as a dispensing practitioner in compliance with s.
  533  465.0276.
  534         3. The physician assistant must complete a minimum of 10
  535  continuing medical education hours in the specialty practice in
  536  which the physician assistant has prescriptive privileges with
  537  each licensure renewal. Three of the 10 hours must consist of a
  538  continuing education course on the safe and effective
  539  prescribing of controlled substance medications which is offered
  540  by a statewide professional association of physicians in this
  541  state accredited to provide educational activities designated
  542  for the American Medical Association Physician’s Recognition
  543  Award Category 1 credit or designated by the American Academy of
  544  Physician Assistants as a Category 1 credit.
  545         4. The department may issue a prescriber number to the
  546  physician assistant granting authority for the prescribing of
  547  medicinal drugs authorized within this paragraph upon completion
  548  of the requirements of this paragraph. The physician assistant
  549  is not required to independently register pursuant to s.
  550  465.0276.
  551         5. The prescription may be in paper or electronic form but
  552  must comply with ss. 456.0392(1) and 456.42(1) and chapter 499
  553  and must contain, in addition to the supervising physician’s
  554  name, address, and telephone number, the physician assistant’s
  555  prescriber number. Unless it is a drug or drug sample dispensed
  556  by the physician assistant, the prescription must be filled in a
  557  pharmacy permitted under chapter 465 and must be dispensed in
  558  that pharmacy by a pharmacist licensed under chapter 465. The
  559  inclusion of the prescriber number creates a presumption that
  560  the physician assistant is authorized to prescribe the medicinal
  561  drug and the prescription is valid.
  562         6. The physician assistant must note the prescription or
  563  dispensing of medication in the appropriate medical record.
  564         Section 8. Paragraph (d) of subsection (3) of section
  565  459.0137, Florida Statutes, is amended to read:
  566         459.0137 Pain-management clinics.—
  567         (3) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  568  apply to any osteopathic physician who provides professional
  569  services in a pain-management clinic that is required to be
  570  registered in subsection (1).
  571         (d) An osteopathic physician authorized to prescribe
  572  controlled substances who practices at a pain-management clinic
  573  is responsible for maintaining the control and security of his
  574  or her electronic prescribing software prescription blanks and
  575  any other method used for prescribing controlled substance pain
  576  medication. The osteopathic physician shall comply with the
  577  requirements for counterfeit-resistant prescription blanks in s.
  578  893.065 and the rules adopted pursuant to that section. The
  579  osteopathic physician shall notify, in writing, the department
  580  within 24 hours after following any theft or loss of a
  581  prescription blank or breach of his or her electronic
  582  prescribing software of any other method for prescribing pain
  583  medication.
  584         Section 9. Paragraph (ss) of subsection (1) of section
  585  459.015, Florida Statutes, is amended to read:
  586         459.015 Grounds for disciplinary action; action by the
  587  board and department.—
  588         (1) The following acts constitute grounds for denial of a
  589  license or disciplinary action, as specified in s. 456.072(2):
  590         (ss) Failing to timely notify the department of the theft
  591  of prescription blanks from a pain-management clinic or a breach
  592  of an osteopathic physician’s electronic prescribing software of
  593  other methods for prescribing within 24 hours as required by s.
  594  459.0137(3).
  595         Section 10. Paragraph (e) of subsection (4) of section
  596  459.022, Florida Statutes, is amended to read:
  597         459.022 Physician assistants.—
  598         (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
  599         (e) A supervising physician may delegate to a fully
  600  licensed physician assistant the authority to prescribe or
  601  dispense any medication used in the supervising physician’s
  602  practice unless such medication is listed on the formulary
  603  created pursuant to s. 458.347. A fully licensed physician
  604  assistant may only prescribe or dispense such medication under
  605  the following circumstances:
  606         1. A physician assistant must clearly identify to the
  607  patient that she or he is a physician assistant and must inform
  608  the patient that the patient has the right to see the physician
  609  before a prescription is prescribed or dispensed by the
  610  physician assistant.
  611         2. The supervising physician must notify the department of
  612  her or his intent to delegate, on a department-approved form,
  613  before delegating such authority and of any change in
  614  prescriptive privileges of the physician assistant. Authority to
  615  dispense may be delegated only by a supervising physician who is
  616  registered as a dispensing practitioner in compliance with s.
  617  465.0276.
  618         3. The physician assistant must complete a minimum of 10
  619  continuing medical education hours in the specialty practice in
  620  which the physician assistant has prescriptive privileges with
  621  each licensure renewal.
  622         4. The department may issue a prescriber number to the
  623  physician assistant granting authority for the prescribing of
  624  medicinal drugs authorized within this paragraph upon completion
  625  of the requirements of this paragraph. The physician assistant
  626  is not required to independently register pursuant to s.
  627  465.0276.
  628         5. The prescription may be in paper or electronic form but
  629  must comply with ss. 456.0392(1) and 456.42(1) and chapter 499
  630  and must contain, in addition to the supervising physician’s
  631  name, address, and telephone number, the physician assistant’s
  632  prescriber number. Unless it is a drug or drug sample dispensed
  633  by the physician assistant, the prescription must be filled in a
  634  pharmacy permitted under chapter 465, and must be dispensed in
  635  that pharmacy by a pharmacist licensed under chapter 465. The
  636  inclusion of the prescriber number creates a presumption that
  637  the physician assistant is authorized to prescribe the medicinal
  638  drug and the prescription is valid.
  639         6. The physician assistant must note the prescription or
  640  dispensing of medication in the appropriate medical record.
  641         Section 11. Sections 456.43, 831.311, and 893.065, Florida
  642  Statutes, are repealed.
  643         Section 12. This act shall take effect January 1, 2020.