Bill Text: FL S1682 | 2020 | Regular Session | Introduced


Bill Title: Prescription Drug Price Transparency

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Failed) 2020-03-14 - Died in Banking and Insurance [S1682 Detail]

Download: Florida-2020-S1682-Introduced.html
       Florida Senate - 2020                                    SB 1682
       
       
        
       By Senator Rodriguez
       
       
       
       
       
       37-00392A-20                                          20201682__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug price
    3         transparency; providing a short title; amending s.
    4         465.003, F.S.; defining the terms “pharmacy benefit
    5         manager” and “pharmacy benefit management services”;
    6         creating s. 465.203, F.S.; defining terms; authorizing
    7         specified pharmacies and pharmacists to contract with
    8         pharmacy benefit managers; prohibiting pharmacy
    9         benefit managers from engaging in certain practices;
   10         requiring pharmacy benefit managers to allow payors
   11         access to specified records, data, and information;
   12         requiring pharmacy benefit managers to disclose and
   13         report specified information to the payor; requiring
   14         certain income and financial benefits to be passed
   15         through to payors; requiring pharmacy benefit managers
   16         to allow the Department of Financial Services access
   17         to specified records, data, and information; requiring
   18         the department to investigate certain violations;
   19         providing penalties; providing that specified
   20         violations are subject to the Florida Deceptive and
   21         Unfair Trade Practices Act; providing applicability;
   22         creating s. 499.0284, F.S.; defining terms; requiring
   23         prescription drug manufacturers to annually report
   24         certain information to the Department of Business and
   25         Professional Regulation by a specified date; requiring
   26         the department to publish the reported information on
   27         its website; specifying circumstances under which
   28         prescription drug manufacturers are required to report
   29         certain information to the department; prescribing the
   30         contents of such reports; requiring the department to
   31         publish the reports on its website within a specified
   32         timeframe; authorizing the department to adopt rules;
   33         amending s. 624.490, F.S.; conforming provisions to
   34         changes made by the act; creating s. 624.491, F.S.;
   35         defining terms; requiring pharmacy benefit managers to
   36         submit annual reports to the Office of Insurance
   37         Regulation by a specified date; prescribing the
   38         contents of such reports; prohibiting the annual
   39         reports from disclosing certain information; requiring
   40         the office to publish the data from the annual reports
   41         on its website by a specified date; prohibiting the
   42         office from publishing the data in a manner that may
   43         disclose certain information; authorizing the
   44         Financial Services Commission to adopt rules; creating
   45         s. 627.42385, F.S.; defining terms; requiring group
   46         health plans, health insurers, and certain pharmacy
   47         benefit managers to base plan beneficiaries’ and
   48         insureds’ coinsurance obligations for certain
   49         prescription drugs on specified drug prices; providing
   50         applicability; prohibiting such group health plans,
   51         health insurers, and pharmacy benefit managers from
   52         revealing specified information; requiring such
   53         entities to protect such information and impose the
   54         confidentiality protections on other entities;
   55         providing penalties; requiring the department to
   56         investigate certain violations; providing
   57         construction; amending ss. 627.64741, 627.6572, and
   58         641.314, F.S.; conforming provisions to changes made
   59         by the act; providing requirements for contracts;
   60         requiring pharmacy benefit managers to allow insurers,
   61         health maintenance organizations, and payors access to
   62         specified records, data, and information; requiring
   63         pharmacy benefit managers to disclose and report
   64         specified information to the insurer, health
   65         maintenance organization, or payor; requiring the
   66         department to investigate certain violations;
   67         providing penalties; providing applicability; creating
   68         ss. 627.64745, 627.65725, and 641.262, F.S.; defining
   69         the terms “specialty drug” and “utilization
   70         management”; requiring insurers issuing individual and
   71         group health insurance policies, and health
   72         maintenance organizations, respectively, to annually
   73         submit reports to the office by a specified date;
   74         prescribing the contents of such reports; prohibiting
   75         such reports from disclosing certain information;
   76         requiring the office to publish data from the reports
   77         on its website by a specified date; prohibiting the
   78         office from publishing the data in a manner that may
   79         disclose certain information; authorizing the
   80         commission to adopt rules; amending ss. 409.9201,
   81         458.331, 459.015, 465.014, 465.015, 465.0156, 465.016,
   82         465.0197, 465.022, 465.023, 465.1901, 499.003, and
   83         893.02, F.S.; conforming cross-references; providing
   84         an effective date.
   85          
   86  Be It Enacted by the Legislature of the State of Florida:
   87  
   88         Section 1. This act may be cited as the “Prescription Drug
   89  Price Transparency Act.”
   90         Section 2. Section 465.003, Florida Statutes, is amended to
   91  read:
   92         465.003 Definitions.—As used in this chapter, the term:
   93         (1) “Administration” means the obtaining and giving of a
   94  single dose of medicinal drugs by a legally authorized person to
   95  a patient for her or his consumption.
   96         (3)(2) “Board” means the Board of Pharmacy.
   97         (9)(3) “Consultant pharmacist” means a pharmacist licensed
   98  by the department and certified as a consultant pharmacist
   99  pursuant to s. 465.0125.
  100         (10)(4) “Data communication device” means an electronic
  101  device that receives electronic information from one source and
  102  transmits or routes it to another, including, but not limited
  103  to, any such bridge, router, switch, or gateway.
  104         (11)(5) “Department” means the Department of Health.
  105         (12)(6) “Dispense” means the transfer of possession of one
  106  or more doses of a medicinal drug by a pharmacist to the
  107  ultimate consumer or her or his agent. As an element of
  108  dispensing, the pharmacist shall, prior to the actual physical
  109  transfer, interpret and assess the prescription order for
  110  potential adverse reactions, interactions, and dosage regimen
  111  she or he deems appropriate in the exercise of her or his
  112  professional judgment, and the pharmacist shall certify that the
  113  medicinal drug called for by the prescription is ready for
  114  transfer. The pharmacist shall also provide counseling on proper
  115  drug usage, either orally or in writing, if in the exercise of
  116  her or his professional judgment counseling is necessary. The
  117  actual sales transaction and delivery of such drug shall not be
  118  considered dispensing. The administration shall not be
  119  considered dispensing.
  120         (13)(7) “Institutional formulary system” means a method
  121  whereby the medical staff evaluates, appraises, and selects
  122  those medicinal drugs or proprietary preparations which in the
  123  medical staff’s clinical judgment are most useful in patient
  124  care, and which are available for dispensing by a practicing
  125  pharmacist in a Class II or Class III institutional pharmacy.
  126         (14)(8) “Medicinal drugs” or “drugs” means those substances
  127  or preparations commonly known as “prescription” or “legend”
  128  drugs which are required by federal or state law to be dispensed
  129  only on a prescription, but shall not include patents or
  130  proprietary preparations as hereafter defined.
  131         (17)(9) “Patent or proprietary preparation” means a
  132  medicine in its unbroken, original package which is sold to the
  133  public by, or under the authority of, the manufacturer or
  134  primary distributor thereof and which is not misbranded under
  135  the provisions of the Florida Drug and Cosmetic Act.
  136         (18)(10) “Pharmacist” means any person licensed pursuant to
  137  this chapter to practice the profession of pharmacy.
  138         (19)(11)(a) “Pharmacy” includes a community pharmacy, an
  139  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
  140  and an Internet pharmacy.
  141         1. The term “community pharmacy” includes every location
  142  where medicinal drugs are compounded, dispensed, stored, or sold
  143  or where prescriptions are filled or dispensed on an outpatient
  144  basis.
  145         2. The term “institutional pharmacy” includes every
  146  location in a hospital, clinic, nursing home, dispensary,
  147  sanitarium, extended care facility, or other facility,
  148  hereinafter referred to as “health care institutions,” where
  149  medicinal drugs are compounded, dispensed, stored, or sold.
  150         3. The term “nuclear pharmacy” includes every location
  151  where radioactive drugs and chemicals within the classification
  152  of medicinal drugs are compounded, dispensed, stored, or sold.
  153  The term “nuclear pharmacy” does not include hospitals licensed
  154  under chapter 395 or the nuclear medicine facilities of such
  155  hospitals.
  156         4. The term “special pharmacy” includes every location
  157  where medicinal drugs are compounded, dispensed, stored, or sold
  158  if such locations are not otherwise defined in this subsection.
  159         5. The term “Internet pharmacy” includes locations not
  160  otherwise licensed or issued a permit under this chapter, within
  161  or outside this state, which use the Internet to communicate
  162  with or obtain information from consumers in this state and use
  163  such communication or information to fill or refill
  164  prescriptions or to dispense, distribute, or otherwise engage in
  165  the practice of pharmacy in this state. Any act described in
  166  this definition constitutes the practice of pharmacy as defined
  167  in subsection (23) (13).
  168         (b) The pharmacy department of any permittee shall be
  169  considered closed whenever a Florida licensed pharmacist is not
  170  present and on duty. The term “not present and on duty” shall
  171  not be construed to prevent a pharmacist from exiting the
  172  prescription department for the purposes of consulting or
  173  responding to inquiries or providing assistance to patients or
  174  customers, attending to personal hygiene needs, or performing
  175  any other function for which the pharmacist is responsible,
  176  provided that such activities are conducted in a manner
  177  consistent with the pharmacist’s responsibility to provide
  178  pharmacy services.
  179         (20)“Pharmacy benefit manager” means an entity that
  180  performs pharmacy benefit management services for a health plan,
  181  a health plan sponsor, a health plan provider, a health insurer,
  182  or any other payor. The term does not include a provider as
  183  defined in s. 641.19, a physician as defined in s. 458.305, or
  184  an osteopathic physician as defined in s. 459.003.
  185         (21)“Pharmacy benefit management services” means services
  186  that:
  187         (a)Are provided, directly or through another entity, to a
  188  health plan, a health plan sponsor, a health plan provider, a
  189  health insurer, or any other payor, regardless of whether the
  190  services provider and the health plan, health plan sponsor,
  191  health plan provider, health insurer, or other payor are related
  192  or associated by ownership, common ownership, organization, or
  193  otherwise.
  194         (b)Include the procurement of prescription drugs to be
  195  dispensed to patients and the administration or management of
  196  prescription drug benefits, including, but not limited to, any
  197  of the following:
  198         1.A mail service pharmacy or a specialty pharmacy.
  199         2.Claims processing, retail network management, or payment
  200  of claims to pharmacies for dispensing drugs.
  201         3.Clinical or other formulary or preferred-drug-list
  202  development or management.
  203         4.Negotiation, administration, or receipt of rebates,
  204  discounts, payment differentials, or other incentives, to
  205  include particular drugs in a particular category or to promote
  206  the purchase of particular drugs.
  207         5.Patients’ compliance, therapeutic intervention, or
  208  generic substitution programs.
  209         6.Disease management.
  210         7.Drug use review, step-therapy protocol, or prior
  211  authorization.
  212         8.Adjudication of appeals or grievances related to
  213  prescription drug coverage.
  214         9.Contracts with network pharmacies.
  215         10.Control of the cost of covered prescription drugs.
  216         (22)(12) “Pharmacy intern” means a person who is currently
  217  registered in, and attending, a duly accredited college or
  218  school of pharmacy, or who is a graduate of such a school or
  219  college of pharmacy, and who is duly and properly registered
  220  with the department as provided for under its rules.
  221         (23)(13) “Practice of the profession of pharmacy” includes
  222  compounding, dispensing, and consulting concerning contents,
  223  therapeutic values, and uses of any medicinal drug; consulting
  224  concerning therapeutic values and interactions of patent or
  225  proprietary preparations, whether pursuant to prescriptions or
  226  in the absence and entirely independent of such prescriptions or
  227  orders; and conducting other pharmaceutical services. For
  228  purposes of this subsection, “other pharmaceutical services”
  229  means the monitoring of the patient’s drug therapy and assisting
  230  the patient in the management of his or her drug therapy, and
  231  includes review of the patient’s drug therapy and communication
  232  with the patient’s prescribing health care provider as licensed
  233  under chapter 458, chapter 459, chapter 461, or chapter 466, or
  234  similar statutory provision in another jurisdiction, or such
  235  provider’s agent or such other persons as specifically
  236  authorized by the patient, regarding the drug therapy. However,
  237  nothing in this subsection may be interpreted to permit an
  238  alteration of a prescriber’s directions, the diagnosis or
  239  treatment of any disease, the initiation of any drug therapy,
  240  the practice of medicine, or the practice of osteopathic
  241  medicine, unless otherwise permitted by law. “Practice of the
  242  profession of pharmacy” also includes any other act, service,
  243  operation, research, or transaction incidental to, or forming a
  244  part of, any of the foregoing acts, requiring, involving, or
  245  employing the science or art of any branch of the pharmaceutical
  246  profession, study, or training, and shall expressly permit a
  247  pharmacist to transmit information from persons authorized to
  248  prescribe medicinal drugs to their patients. The practice of the
  249  profession of pharmacy also includes the administration of
  250  vaccines to adults pursuant to s. 465.189 and the preparation of
  251  prepackaged drug products in facilities holding Class III
  252  institutional pharmacy permits.
  253         (24)(14) “Prescription” includes any order for drugs or
  254  medicinal supplies written or transmitted by any means of
  255  communication by a duly licensed practitioner authorized by the
  256  laws of the state to prescribe such drugs or medicinal supplies
  257  and intended to be dispensed by a pharmacist. The term also
  258  includes an orally transmitted order by the lawfully designated
  259  agent of such practitioner. The term also includes an order
  260  written or transmitted by a practitioner licensed to practice in
  261  a jurisdiction other than this state, but only if the pharmacist
  262  called upon to dispense such order determines, in the exercise
  263  of her or his professional judgment, that the order is valid and
  264  necessary for the treatment of a chronic or recurrent illness.
  265  The term “prescription” also includes a pharmacist’s order for a
  266  product selected from the formulary created pursuant to s.
  267  465.186. Prescriptions may be retained in written form or the
  268  pharmacist may cause them to be recorded in a data processing
  269  system, provided that such order can be produced in printed form
  270  upon lawful request.
  271         (15) “Nuclear pharmacist” means a pharmacist licensed by
  272  the department and certified as a nuclear pharmacist pursuant to
  273  s. 465.0126.
  274         (5)(16) “Centralized prescription filling” means the
  275  filling of a prescription by one pharmacy upon request by
  276  another pharmacy to fill or refill the prescription. The term
  277  includes the performance by one pharmacy for another pharmacy of
  278  other pharmacy duties such as drug utilization review,
  279  therapeutic drug utilization review, claims adjudication, and
  280  the obtaining of refill authorizations.
  281         (2)(17) “Automated pharmacy system” means a mechanical
  282  system that delivers prescription drugs received from a Florida
  283  licensed pharmacy and maintains related transaction information.
  284         (8)(18) “Compounding” means combining, mixing, or altering
  285  the ingredients of one or more drugs or products to create
  286  another drug or product.
  287         (16)(19) “Outsourcing facility” means a single physical
  288  location registered as an outsourcing facility under the federal
  289  Drug Quality and Security Act, Pub. L. No. 113-54, at which
  290  sterile compounding of a drug or product is conducted.
  291         (7)(20) “Compounded sterile product” means a drug that is
  292  intended for parenteral administration, an ophthalmic or oral
  293  inhalation drug in aqueous format, or a drug or product that is
  294  required to be sterile under federal or state law or rule, which
  295  is produced through compounding, but is not approved by the
  296  United States Food and Drug Administration.
  297         (4)(21) “Central distribution facility” means a facility
  298  under common control with a hospital holding a Class III
  299  institutional pharmacy permit that may dispense, distribute,
  300  compound, or fill prescriptions for medicinal drugs; prepare
  301  prepackaged drug products; and conduct other pharmaceutical
  302  services.
  303         (6)(22) “Common control” means the power to direct or cause
  304  the direction of the management and policies of a person or an
  305  organization, whether by ownership of stock, voting rights,
  306  contract, or otherwise.
  307         Section 3. Section 465.203, Florida Statutes, is created to
  308  read:
  309         465.203Pharmacy benefit managers.—
  310         (1)As used in this section, the term:
  311         (a)“Affiliate” means a pharmacy:
  312         1.In which a pharmacy benefit manager, directly or
  313  indirectly, has an investment, financial interest, or ownership
  314  interest; or
  315         2.The ownership of which is shared, directly or
  316  indirectly, with a pharmacy benefit manager.
  317         (b)“Covered individual” means a member, participant,
  318  enrollee, contract holder, policyholder, or beneficiary of a
  319  payor.
  320         (c)“Make a referral” means any of the following:
  321         1.To order, direct, or influence, orally or in writing, a
  322  covered individual to use an affiliate, including by sending
  323  messages to the covered individual through electronic mail, a
  324  cellular telephone, or a facsimile machine, or by making
  325  telephone calls.
  326         2.To offer or implement plan designs that require a
  327  covered individual to use an affiliate.
  328         3.To target a covered individual or a prospective patient
  329  with advertisement, marketing, or promotion of an affiliate,
  330  including by placing a specific pharmacy name on an insurance
  331  card or health plan card supplied to the covered individual.
  332         (d)“Maximum allowable cost” means the per-unit amount that
  333  a pharmacy benefit manager reimburses a pharmacy or pharmacist
  334  for a generic drug, brand name drug, specialty drug, biological
  335  product, or other prescription drug, excluding dispensing fees,
  336  before the application of copayments, coinsurance, and other
  337  cost-sharing charges, if any.
  338         (e)“Maximum allowable cost list” means a listing of
  339  generic drugs, brand name drugs, specialty drugs, biological
  340  products, or other prescription drugs or other methodology used
  341  directly or indirectly by a pharmacy benefit manager to set the
  342  maximum allowable costs for the drugs.
  343         (f)“Payor” means a health plan, a health plan sponsor, a
  344  health plan provider, a health insurer, or any other payor that
  345  uses pharmacy benefit management services in this state.
  346         (g)“Spread pricing” means the practice by a pharmacy
  347  benefit manager of charging or claiming from a payor an amount
  348  that is more than the amount the pharmacy benefit manager paid
  349  to the pharmacy or pharmacist who filled the prescription or who
  350  provided the pharmacy services.
  351         (2)A pharmacy or pharmacist licensed or registered under
  352  this chapter who has a pharmacy permit and is in good standing
  353  with the Board of Pharmacy may contract directly or indirectly
  354  with a pharmacy benefit manager within 30 days after filing an
  355  application with the pharmacy benefit manager, without a
  356  probation period, an exclusion period, or minimum inventory
  357  requirements.
  358         (3)A pharmacy benefit manager may not do any of the
  359  following:
  360         (a)Conduct or participate in spread pricing in this state.
  361         (b)Charge a pharmacy or pharmacist a fee related to the
  362  adjudication of a claim, including, without limitation, a fee
  363  for:
  364         1.The submission of a claim;
  365         2.The enrollment or participation in a retail pharmacy
  366  network; or
  367         3.The development or management of claims processing
  368  services or claims payment services related to participation in
  369  a retail pharmacy network.
  370         (c)Prohibit a pharmacy or pharmacist from providing to a
  371  covered individual or a covered individual’s caregiver
  372  information regarding the pricing of a prescription drug and
  373  whether the cost-sharing obligation to the covered individual
  374  exceeds the retail price of the prescription in the absence of
  375  prescription drug coverage or from selling to a covered
  376  individual or a covered individual’s caregiver a more affordable
  377  alternative drug.
  378         (d)Penalize or remove from a pharmacy network or plan a
  379  pharmacy or pharmacist for providing to a covered individual or
  380  a covered individual’s caregiver information regarding the
  381  pricing of a prescription drug and whether the cost-sharing
  382  obligation to the covered individual exceeds the retail price of
  383  the prescription in the absence of prescription drug coverage or
  384  for selling to a covered individual or a covered individual’s
  385  caregiver a more affordable alternative drug.
  386         (e)Deny a pharmacy or pharmacist the opportunity to
  387  participate in a pharmacy network at the preferred participation
  388  status even though the pharmacy or pharmacist is willing to
  389  accept, as a condition of the preferred participation status,
  390  the terms and conditions that the pharmacy benefit manager has
  391  established for other pharmacies that are in a pharmacy network
  392  at the preferred participation status and that are not owned in
  393  whole or in part by the pharmacy benefit manager.
  394         (f)Impose registration or permit requirements for a
  395  pharmacy or accreditation standards or recertification
  396  requirements for a pharmacist which are inconsistent with, more
  397  stringent than, or in addition to federal and state requirements
  398  for licensure as a pharmacy or pharmacist in this state.
  399         (g)Pay or reimburse a pharmacy or pharmacist an amount for
  400  a drug, product, or pharmacy service in the state which is:
  401         1.Less than the amount the pharmacy benefit manager
  402  reimburses a pharmacy benefit manager affiliate for providing
  403  the same drug, product, or pharmacy service in this state;
  404         2.Less than the actual cost incurred by the pharmacy or
  405  pharmacist for providing the drug, product, or pharmacy service
  406  in this state; or
  407         3.Different from the combined maximum allowable cost and
  408  dispensing fees for a drug. The dispensing fees must be at least
  409  equal to the fees for service set by the Agency for Health Care
  410  Administration.
  411         (h)Retroactively deny, hold back, or reduce reimbursement
  412  for a covered service claim after paying a claim, unless the
  413  original claim was submitted fraudulently.
  414         (i)Prohibit a pharmacy or pharmacist from providing
  415  information regarding drug pricing, contract terms, or drug
  416  reimbursement rates to a member of the Legislature.
  417         (j)Remove a pharmacy or pharmacist from a pharmacy network
  418  or plan or otherwise engage in any action to retaliate against a
  419  pharmacy or pharmacist for providing information regarding drug
  420  pricing, contract terms, or drug reimbursement rates to a member
  421  of the Legislature.
  422         (k)Engage in the practice of the profession of pharmacy.
  423         (l)Engage in the practice of medicine as defined s.
  424  458.305 or the practice of osteopathic medicine as defined in s.
  425  459.003.
  426         (m)Make a referral.
  427         (n)Publish or otherwise reveal information regarding the
  428  actual amount of rebates, discounts, payment differentials,
  429  concessions, reductions, or any other incentives that the
  430  pharmacy benefit plan receives on a product-, manufacturer-, or
  431  pharmacy-specific basis. The pharmacy benefit manager shall
  432  protect such information as a trade secret and shall impose the
  433  confidentiality protections on any vendor or third-party entity
  434  performing services on behalf of the pharmacy benefit manager
  435  that has access to rebate, discount, payment differential,
  436  concession, reduction, or any other incentive information.
  437         (4)A payor shall have access to all financial and
  438  utilization records, data, and information used by the pharmacy
  439  benefit manager in relation to the pharmacy benefit management
  440  services provided to the payor.
  441         (5)A pharmacy benefit manager shall:
  442         (a)Disclose in writing to the payor any activity, policy,
  443  practice, contract, or arrangement of the pharmacy benefit
  444  manager which directly or indirectly presents conflicts of
  445  interest with the pharmacy benefit manager’s relationship with,
  446  or fiduciary duty or obligation to, the covered individuals and
  447  the payor.
  448         (b)Report quarterly to the payor any income resulting from
  449  pricing discounts, rebates of any kind, inflationary payments,
  450  credits, clawbacks, fees, grants, chargebacks, reimbursements,
  451  or other financial benefits received by the pharmacy benefit
  452  manager from any person or entity. The pharmacy benefit manager
  453  shall ensure that such income and financial benefits are passed
  454  through in full, at least quarterly, to the payor to reduce the
  455  cost of prescription drugs and pharmacy services to covered
  456  individuals.
  457         (6)The Department of Financial Services shall have access
  458  to all financial and utilization records, data, and information
  459  used by pharmacy benefit managers in relation to pharmacy
  460  benefit management services provided to payors in this state.
  461  The department shall investigate any alleged violation of this
  462  section.
  463         (7)(a)A pharmacy benefit manager that violates this
  464  section is liable for a civil fine of $10,000 for each violation
  465  and may have its registration revoked by the Department of
  466  Financial Services.
  467         (b)A violation of this section which is committed or
  468  performed with such frequency as to indicate a general business
  469  practice is subject to the Florida Deceptive and Unfair Trade
  470  Practices Act under part II of chapter 501.
  471         (8)This section applies to contracts entered into or
  472  renewed on or after January 1, 2021.
  473         Section 4. Section 499.0284, Florida Statutes, is created
  474  to read:
  475         499.0284 Prescription drug manufacturers; disclosure of
  476  drug pricing information; reports.—
  477         (1)As used in this section, the term:
  478         (a)“Prescription drug” has the same meaning as defined in
  479  this part, but is limited to prescription drugs intended for
  480  human use.
  481         (b)“Prescription drug manufacturer” means a person or
  482  entity permitted under this part to manufacture or distribute
  483  prescription drugs in this state.
  484         (c)“Prompt pay” means a discount offered in exchange for
  485  early payment of an invoice.
  486         (d)“Wholesale acquisition cost” means the list price of
  487  the prescription drug which the manufacturer charged to
  488  wholesalers or direct purchasers in the United States, not
  489  including prompt pay or other discounts, rebates, or reductions
  490  in price, for the most recent month for which the information is
  491  available, as reported in wholesale price guides or other drug
  492  pricing data sources.
  493         (2)(a)By January 15 of each year, each prescription drug
  494  manufacturer manufacturing or distributing prescription drugs in
  495  this state shall submit to the department a report of its
  496  wholesale acquisition cost information for all United States
  497  Food and Drug Administration-approved drugs the manufacturer
  498  sold in or into this state during the previous calendar year.
  499         (b)The department shall publish on its website the
  500  wholesale acquisition cost information it receives pursuant to
  501  paragraph (a). The link to this information must be prominently
  502  displayed and easily accessible on the home page of the
  503  department’s website.
  504         (c)A prescription drug manufacturer shall report to the
  505  department when the price of a drug it manufactures increases by
  506  40 percent or more during the preceding 3 years or by 15 percent
  507  in the preceding calendar year, if the wholesale acquisition
  508  cost of the drug was at least $100 for a 30-day supply before
  509  the effective date of the increase. The manufacturer shall
  510  submit such report to the department within 30 days after the
  511  effective date of the increase. The report must include all of
  512  the following:
  513         1.The name of the drug.
  514         2.Whether the drug is a brand name or generic equivalent.
  515         3.The effective date of the change in wholesale
  516  acquisition cost.
  517         4.Aggregate, company-level research and development costs
  518  for the most recent year for which final audit data is
  519  available.
  520         5.The name of each of the manufacturer’s prescription
  521  drugs approved by the United States Food and Drug Administration
  522  in the previous 3 calendar years.
  523         6.The name of each of the manufacturer’s prescription
  524  drugs that lost patent exclusivity in the United States in the
  525  previous 3 calendar years.
  526         7.A statement regarding the factors, if any, that caused
  527  the increase in the wholesale acquisition cost and an
  528  explanation of each factor’s impact on the cost.
  529         (d)The quality and types of information and data which a
  530  prescription drug manufacturer submits to the department under
  531  paragraph (c) must be consistent with the quality and types of
  532  information and data which the manufacturer includes in the
  533  manufacturer’s annual consolidated report to the United States
  534  Securities and Exchange Commission or in any other public
  535  disclosure.
  536         (e)The department shall publish on its website a report
  537  provided under paragraph (c) within 60 days after receiving it.
  538         (f)The department may adopt rules to implement this
  539  section.
  540         Section 5. Subsection (1) of section 624.490, Florida
  541  Statutes, is amended to read:
  542         624.490 Registration of pharmacy benefit managers.—
  543         (1) As used in this section, the term “pharmacy benefit
  544  manager” means an a person or entity that performs pharmacy
  545  benefit management services for a health plan, a health plan
  546  sponsor, a health plan provider, a health insurer, or any other
  547  payor that uses pharmacy benefit management services doing
  548  business in this state which contracts to administer
  549  prescription drug benefits on behalf of a health insurer or a
  550  health maintenance organization to residents of this state. The
  551  term does not include a provider as defined in s. 641.19, a
  552  physician as defined in s. 458.305, or an osteopathic physician
  553  as defined in s. 459.003. As used in this subsection, the term
  554  “pharmacy benefit management services” means services that:
  555         (a)Are provided, directly or through another entity, to a
  556  health plan, a health plan sponsor, a health plan provider, a
  557  health insurer, or any other payor, regardless of whether the
  558  services provider and the health plan, health plan sponsor,
  559  health plan provider, health insurer, or other payor are related
  560  or associated by ownership, common ownership, organization, or
  561  otherwise.
  562         (b)Include the procurement of prescription drugs to be
  563  dispensed to patients and the administration or management of
  564  prescription drug benefits, including, but not limited to, any
  565  of the following:
  566         1.A mail service pharmacy or a specialty pharmacy.
  567         2.Claims processing, retail network management, or payment
  568  of claims to pharmacies for dispensing drugs.
  569         3.Clinical or other formulary or preferred-drug-list
  570  development or management.
  571         4.Negotiation, administration, or receipt of rebates,
  572  discounts, payment differentials, or other incentives, to
  573  include particular drugs in a particular category or to promote
  574  the purchase of particular drugs.
  575         5.Patients’ compliance, therapeutic intervention, or
  576  generic substitution programs.
  577         6.Disease management.
  578         7.Drug use review, step-therapy protocol, or prior
  579  authorization.
  580         8.Adjudication of appeals or grievances related to
  581  prescription drug coverage.
  582         9.Contracts with network pharmacies.
  583         10.Control of the cost of covered prescription drugs.
  584         Section 6. Section 624.491, Florida Statutes, is created to
  585  read:
  586         624.491 Pharmacy benefit managers; reports.—
  587         (1)As used in this section, the term:
  588         (a)“Enrollee” means an individual insured under an
  589  individual or group health insurance policy or a subscriber as
  590  defined in s. 641.19.
  591         (b)“Health insurance” has the same meaning as in s.
  592  624.603.
  593         (c)“Health insurer” means an authorized insurer as defined
  594  in s. 624.03 providing health insurance or a health maintenance
  595  organization as defined in s. 641.19.
  596         (d)“Pharmacy benefit manager” means a person or entity
  597  registered with the office under s. 624.490 to contract on
  598  behalf of a health insurer to administer prescription drug
  599  benefits to residents of this state.
  600         (e)“Prescription drug” has the same meaning as in s.
  601  499.003, but is limited to prescription drugs intended for human
  602  use.
  603         (f)“Prescription drug manufacturer” means a person or
  604  entity permitted under part I of chapter 499 to manufacture or
  605  distribute prescription drugs in this state.
  606         (2)By February 1 of each year, each pharmacy benefit
  607  manager shall submit a report to the office including all of the
  608  following information for the previous calendar year:
  609         (a)The aggregated rebates, fees, price protection
  610  payments, and any other payments collected from prescription
  611  drug manufacturers; and
  612         (b)The aggregated dollar amount of rebates, fees, price
  613  protection payments, and any other payments collected from
  614  prescription drug manufacturers which were:
  615         1.Passed on to the health insurers or the enrollees, at
  616  the point of sale of the prescription drug; or
  617         2.Retained by the pharmacy benefit manager as revenue.
  618         (3)A report submitted under this section must not disclose
  619  the identity of a specific health insurer or enrollee, the price
  620  charged for a specific prescription drug or class of
  621  prescription drugs, or the amount of any rebate or fee provided
  622  for a specific prescription drug or class of prescription drugs.
  623         (4)By May 1 of each year, the office shall publish on its
  624  website the combined aggregated data from all reports it
  625  received under this section for that year. The data from the
  626  reports may not be published in a manner that would disclose or
  627  tend to disclose any health insurer’s proprietary or
  628  confidential information.
  629         (5)The commission may adopt rules to implement this
  630  section.
  631         Section 7. Section 627.42385, Florida Statutes, is created
  632  to read:
  633         627.42385Coinsurance obligations for prescription drugs.—
  634         (1)As used in this section, the term:
  635         (a)“Coinsurance” means, with respect to prescription drug
  636  coverage under a group health plan or health insurance coverage,
  637  a payment obligation of a plan beneficiary or an insured that is
  638  based on a percentage of the specified cost of a prescription
  639  drug, which may be up to 100 percent of that cost.
  640         (b)“Deductible” means the payment obligation of a group
  641  health plan beneficiary or a health insurance coverage insured
  642  before the plan or coverage will pay any portion of the cost of
  643  prescription drug coverage.
  644         (c)“Health insurer” has the same meaning as provided in s.
  645  627.42392.
  646         (d)“List price” means the manufacturer’s price for a drug
  647  for wholesalers or direct purchasers in this country, not
  648  including any rebate, discount, payment differential,
  649  concession, or reduction in price, for the most recent month for
  650  which the information is available, as reported in wholesale
  651  price guides or other publications of drug or biological pricing
  652  data.
  653         (e)“Net price” means the price of a drug paid by a group
  654  health plan or a health insurer, or a pharmacy benefit manager
  655  performing pharmacy benefit management services for a group
  656  health plan or a health insurer, after all rebates, discounts,
  657  payment differentials, concessions, and reductions in price have
  658  been applied to the list price.
  659         (f)“Pharmacy benefit manager” has the same meaning as
  660  provided in s. 465.003.
  661         (g)“Pharmacy benefit management services” has the same
  662  meaning as provided in s. 465.003.
  663         (h)“Prescription drug” has the same meaning as provided in
  664  s. 409.9201.
  665         (2)Unless otherwise expressly provided in this section, a
  666  group health plan or a health insurer offering group or
  667  individual health insurance coverage, or a pharmacy benefit
  668  manager performing pharmacy benefit management services for a
  669  group health plan or a health insurer, shall base a plan
  670  beneficiary’s or an insured’s coinsurance obligation for a
  671  prescription drug covered by the plan or coverage on the net
  672  price, and not the list price, of the drug.
  673         (3)(a)Subsection (2) applies to a prescription drug
  674  benefit if a plan beneficiary or an insured is required to pay a
  675  deductible with respect to such benefit and if the plan
  676  beneficiary or insured:
  677         1.Has not yet satisfied the deductible under the plan or
  678  coverage; or
  679         2.Has another coinsurance obligation with respect to such
  680  benefit under the plan or coverage.
  681         (b)Subsection (2) does not apply if, with respect to the
  682  dispensed quantity of a prescription drug, the net price and
  683  list price of the drug are different by not more than 1 percent.
  684         (4)In complying with this section, a group health plan or
  685  a health insurer, or a pharmacy benefit manager performing
  686  pharmacy benefit management services for a group health plan or
  687  a health insurer, may not publish or otherwise reveal
  688  information regarding the actual amount of rebates, discounts,
  689  payment differentials, concessions, or reductions in price that
  690  the plan, health insurer, or pharmacy benefit plan receives on a
  691  product-, manufacturer-, or pharmacy-specific basis. The plan,
  692  health insurer, or pharmacy benefit manager shall protect such
  693  information as a trade secret and shall impose the
  694  confidentiality protections on any vendor or third party
  695  performing health care or pharmacy administrative services on
  696  behalf of the plan, health insurer, or pharmacy benefit manager
  697  that have access to rebate, discount, payment differential,
  698  concession, or reduction information.
  699         (5)A group health plan, health insurer, or pharmacy
  700  benefit manager that violates any provision of this section is
  701  liable for a civil fine of $10,000 for each violation and may be
  702  required to discontinue the issuance or renewal of the plan or
  703  health insurance coverage or the provision of pharmacy benefit
  704  management services, as applicable.
  705         (6)The department shall investigate any alleged violation
  706  of this section.
  707         (7)This section does not prevent a group health plan,
  708  health insurer, or pharmacy benefit manager from requiring a
  709  copayment for any prescription drug if such copayment is not
  710  tied to a percentage of the cost of the drug.
  711         Section 8. Present subsection (5) of section 627.64741,
  712  Florida Statutes, is redesignated as subsection (10), new
  713  subsections (5) through (9) are added to that section, and
  714  subsection (1) and present subsection (5) are amended, to read:
  715         627.64741 Pharmacy benefit manager contracts.—
  716         (1) As used in this section, the term:
  717         (a) “Maximum allowable cost” means the per-unit amount that
  718  a pharmacy benefit manager reimburses a pharmacy or pharmacist
  719  for a generic drug, brand name drug, specialty drug, biological
  720  product, or other prescription drug, excluding dispensing fees,
  721  before prior to the application of copayments, coinsurance, and
  722  other cost-sharing charges, if any.
  723         (b)“Maximum allowable cost list” means a listing of
  724  generic drugs, brand name drugs, specialty drugs, biological
  725  products, or other prescription drugs or other methodology used
  726  directly or indirectly by a pharmacy benefit manager to set the
  727  maximum allowable costs for the drugs.
  728         (c)“Payor” means a health plan, a health plan sponsor, a
  729  health plan provider, or any other payor that uses pharmacy
  730  benefit management services in this state.
  731         (d)(b) “Pharmacy benefit manager” means an a person or
  732  entity that performs pharmacy benefit management services for
  733  doing business in this state which contracts to administer or
  734  manage prescription drug benefits on behalf of a health insurer
  735  or payor to residents of this state. The term does not include a
  736  provider as defined in s. 641.19, a physician as defined in s.
  737  458.305, or an osteopathic physician as defined in s. 459.003.
  738         (e)“Pharmacy benefit management services” means services
  739  that:
  740         1.Are provided, directly or through another entity, to a
  741  health insurer or payor, regardless of whether the services
  742  provider and the health insurer or payor are related or
  743  associated by ownership, common ownership, organization, or
  744  otherwise.
  745         2.Include the procurement of prescription drugs to be
  746  dispensed to patients and the administration or management of
  747  prescription drug benefits, including, but not limited to, any
  748  of the following:
  749         a.A mail service pharmacy or a specialty pharmacy.
  750         b.Claims processing, retail network management, or payment
  751  of claims to pharmacies for dispensing drugs.
  752         c.Clinical or other formulary or preferred-drug-list
  753  development or management.
  754         d.Negotiation, administration, or receipt of rebates,
  755  discounts, payment differentials, or other incentives, to
  756  include particular drugs in a particular category or to promote
  757  the purchase of particular drugs.
  758         e.Patients’ compliance, therapeutic intervention, or
  759  generic substitution programs.
  760         f.Disease management.
  761         g.Drug use review, step-therapy protocol, or prior
  762  authorization.
  763         h.Adjudication of appeals or grievances related to
  764  prescription drug coverage.
  765         i.Contracts with network pharmacies.
  766         j.Control of the cost of covered prescription drugs.
  767         (5)A contract between a health insurer or payor and a
  768  pharmacy benefit manager must require the maximum allowable cost
  769  list to include:
  770         (a)Average acquisition cost, including national average
  771  drug acquisition cost.
  772         (b)Average manufacturer price.
  773         (c)Average wholesale price.
  774         (d)Brand effective rate or generic effective rate.
  775         (e)Discount indexing.
  776         (f)Federal upper limits.
  777         (g)Wholesale acquisition cost.
  778         (h)Any other item that a pharmacy benefit manager or a
  779  health insurer or payor may use to establish reimbursement rates
  780  to a pharmacist or pharmacy for filling prescriptions or
  781  providing other pharmacy services.
  782         (6)A health insurer that uses pharmacy benefit management
  783  services or a payor shall have access to all financial and
  784  utilization records, data, and information used by the pharmacy
  785  benefit manager in relation to the pharmacy benefit management
  786  services provided to the health insurer or payor.
  787         (7)A pharmacy benefit manager shall:
  788         (a)Disclose in writing to the health insurer that uses
  789  pharmacy benefit management services or to the payor any
  790  activity, policy, practice, contract, or arrangement of the
  791  pharmacy benefit manager which directly or indirectly presents
  792  conflicts of interest with the pharmacy benefit manager’s
  793  relationship with, or fiduciary duty or obligation to, the
  794  insureds and the health insurer or payor.
  795         (b)Report quarterly to the health insurer or payor any
  796  income resulting from pricing discounts, rebates of any kind,
  797  inflationary payments, credits, clawbacks, fees, grants,
  798  chargebacks, reimbursements, or other financial benefits
  799  received by the pharmacy benefit manager from any person or
  800  entity. The pharmacy benefit manager shall ensure that such
  801  income and financial benefits are passed through in full, at
  802  least quarterly, to the health insurer or payor to reduce the
  803  cost of prescription drugs and pharmacy services to the
  804  insureds.
  805         (8)The department shall investigate any alleged violation
  806  of this section.
  807         (9)(a)A pharmacy benefit manager that violates any
  808  provision of this section is liable for a civil fine of $10,000
  809  for each violation and may have its registration revoked by the
  810  department.
  811         (b)A violation by a pharmacy benefit manager of any
  812  provision of this section which is committed or performed with
  813  such frequency as to indicate a general business practice is
  814  subject to the Florida Deceptive and Unfair Trade Practices Act
  815  under part II of chapter 501.
  816         (10)(5) This section applies to contracts entered into or
  817  renewed on or after January 1, 2021 July 1, 2018.
  818         Section 9. Section 627.64745, Florida Statutes, is created
  819  to read:
  820         627.64745 Health insurers; prescription drug spending
  821  reports.—
  822         (1)As used in this section, the term:
  823         (a)“Specialty drug” means a prescription drug on a health
  824  insurer’s formulary which is also covered under Medicare Part D
  825  and exceeds the specialty tier cost threshold established by the
  826  federal Centers for Medicare and Medicaid Services.
  827         (b)“Utilization management” means a set of formal
  828  techniques designed to monitor the use of or evaluate the
  829  medical necessity, appropriateness, efficacy, or efficiency of
  830  health care services, procedures, or settings.
  831         (2)By February 1 of each year, each health insurer shall
  832  submit to the office a report including all of the following
  833  information across all health insurance policies for the
  834  preceding calendar year:
  835         (a)The names of the 25 most frequently prescribed
  836  prescription drugs.
  837         (b)The percentage of any increase in annual net spending
  838  for prescription drugs.
  839         (c)The percentage of any increase in premiums which was
  840  attributable to prescription drugs.
  841         (d)The percentage of specialty drugs with utilization
  842  management requirements prescribed.
  843         (e)Any premium reductions that were attributable to
  844  specialty drug utilization management.
  845         (3)A report submitted under this section must not disclose
  846  the identity of a specific health insurance policy or the price
  847  charged for a specific prescription drug or class of
  848  prescription drugs.
  849         (4)By May 1 of each year, the office shall publish on its
  850  website aggregated data from all reports it received under this
  851  section for that year. The data from the reports may not be
  852  published in a manner that would disclose or tend to disclose
  853  any health insurer’s proprietary or confidential information.
  854         (5)The commission may adopt rules to implement this
  855  section.
  856         Section 10. Present subsection (5) of section 627.6572,
  857  Florida Statutes, is redesignated as subsection (10) and
  858  amended, a new subsection (5) and subsections (6) through (9)
  859  are added to that section, and subsection (1) is amended, to
  860  read:
  861         627.6572 Pharmacy benefit manager contracts.—
  862         (1) As used in this section, the term:
  863         (a) “Maximum allowable cost” means the per-unit amount that
  864  a pharmacy benefit manager reimburses a pharmacy or pharmacist
  865  for a generic drug, brand name drug, specialty drug, biological
  866  product, or other prescription drug, excluding dispensing fees,
  867  before prior to the application of copayments, coinsurance, and
  868  other cost-sharing charges, if any.
  869         (b)“Maximum allowable cost list” means a listing of
  870  generic drugs, brand name drugs, specialty drugs, biological
  871  products, or other prescription drugs or other methodology used
  872  directly or indirectly by a pharmacy benefit manager to set the
  873  maximum allowable costs for the drugs.
  874         (c)“Payor” means a health plan, a health plan sponsor, a
  875  health plan provider, or any other payor that uses pharmacy
  876  benefit management services in this state.
  877         (d)(b) “Pharmacy benefit manager” means an a person or
  878  entity that performs pharmacy benefit management services for
  879  doing business in this state which contracts to administer or
  880  manage prescription drug benefits on behalf of a health insurer
  881  or payor to residents of this state. The term does not include a
  882  provider as defined in s. 641.19, a physician as defined in s.
  883  458.305, or an osteopathic physician as defined in s. 459.003.
  884         (e)“Pharmacy benefit management services” means services
  885  that:
  886         1.Are provided, directly or through another entity, to a
  887  health insurer or payor, regardless of whether the services
  888  provider and the health insurer or payor are related or
  889  associated by ownership, common ownership, organization, or
  890  otherwise.
  891         2.Include the procurement of prescription drugs to be
  892  dispensed to patients and the administration or management of
  893  prescription drug benefits, including, but not limited to, any
  894  of the following:
  895         a.A mail service pharmacy or a specialty pharmacy.
  896         b.Claims processing, retail network management, or payment
  897  of claims to pharmacies for dispensing drugs.
  898         c.Clinical or other formulary or preferred-drug-list
  899  development or management.
  900         d.Negotiation, administration, or receipt of rebates,
  901  discounts, payment differentials, or other incentives, to
  902  include particular drugs in a particular category or to promote
  903  the purchase of particular drugs.
  904         e.Patients’ compliance, therapeutic intervention, or
  905  generic substitution programs.
  906         f.Disease management.
  907         g.Drug use review, step-therapy protocol, or prior
  908  authorization.
  909         h.Adjudication of appeals or grievances related to
  910  prescription drug coverage.
  911         i.Contracts with network pharmacies.
  912         j.Control of the cost of covered prescription drugs.
  913         (5)A contract between a health insurer or payor and a
  914  pharmacy benefit manager must require the maximum allowable cost
  915  list to include:
  916         (a)Average acquisition cost, including national average
  917  drug acquisition cost.
  918         (b)Average manufacturer price.
  919         (c)Average wholesale price.
  920         (d)Brand effective rate or generic effective rate.
  921         (e)Discount indexing.
  922         (f)Federal upper limits.
  923         (g)Wholesale acquisition cost.
  924         (h)Any other item that a pharmacy benefit manager or a
  925  health insurer or payor may use to establish reimbursement rates
  926  to a pharmacist or pharmacy for filling prescriptions or
  927  providing other pharmacy services.
  928         (6)A health insurer that uses pharmacy benefit management
  929  services or a payor shall have access to all financial and
  930  utilization records, data, and information used by the pharmacy
  931  benefit manager in relation to the pharmacy benefit management
  932  services provided to the health insurer or payor.
  933         (7)A pharmacy benefit manager shall:
  934         (a)Disclose in writing to the health insurer that uses
  935  pharmacy benefit management services or the payor any activity,
  936  policy, practice, contract, or arrangement of the pharmacy
  937  benefit manager which directly or indirectly presents conflicts
  938  of interest with the pharmacy benefit manager’s relationship
  939  with, or fiduciary duty or obligation to, the insureds and the
  940  health insurer or payor.
  941         (b)Report quarterly to the health insurer or payor any
  942  income resulting from pricing discounts, rebates of any kind,
  943  inflationary payments, credits, clawbacks, fees, grants,
  944  chargebacks, reimbursements, or other financial benefits
  945  received by the pharmacy benefit manager from any person or
  946  entity. The pharmacy benefit manager shall ensure that such
  947  income and financial benefits are passed through in full, at
  948  least quarterly, to the health insurer or payor to reduce the
  949  cost of prescription drugs and pharmacy services to the
  950  insureds.
  951         (8)The department shall investigate any alleged violation
  952  of this section.
  953         (9)(a)A pharmacy benefit manager that violates any
  954  provision of this section is liable for a civil fine of $10,000
  955  for each violation and may have its registration revoked by the
  956  department.
  957         (b)A violation by a pharmacy benefit manager of any
  958  provision of this section which is committed or performed with
  959  such frequency as to indicate a general business practice is
  960  subject to the Florida Deceptive and Unfair Trade Practices Act
  961  under part II of chapter 501.
  962         (10)(5) This section applies to contracts entered into or
  963  renewed on or after January 1, 2021 July 1, 2018.
  964         Section 11. Section 627.65725, Florida Statutes, is created
  965  to read:
  966         627.65725 Health insurers; prescription drug spending
  967  reports.—
  968         (1)As used in this section, the term:
  969         (a)“Specialty drug” means a prescription drug on a health
  970  insurer’s formulary which is also covered under Medicare Part D
  971  and exceeds the specialty tier cost threshold established by the
  972  federal Centers for Medicare and Medicaid Services.
  973         (b)“Utilization management” means a set of formal
  974  techniques designed to monitor the use of or evaluate the
  975  medical necessity, appropriateness, efficacy, or efficiency of
  976  health care services, procedures, or settings.
  977         (2)By February 1 of each year, each health insurer shall
  978  submit to the office a report including all of the following
  979  information across all group health insurance policies for the
  980  preceding calendar year:
  981         (a)The names of the 25 most frequently prescribed
  982  prescription drugs.
  983         (b)The percentage of any increase in annual net spending
  984  for prescription drugs.
  985         (c)The percentage of any increase in premiums which was
  986  attributable to prescription drugs.
  987         (d)The percentage of specialty drugs with utilization
  988  management requirements prescribed.
  989         (e)Any premium reduction that was attributable to
  990  specialty drug utilization management.
  991         (3)A report submitted under this section must not disclose
  992  the identity of a specific health insurance policy or the price
  993  charged for a specific prescription drug or class of
  994  prescription drugs.
  995         (4)By May 1 of each year, the office shall publish on its
  996  website aggregated data from all reports it received under this
  997  section for that year. The data from the reports may not be
  998  published in a manner that would disclose or tend to disclose
  999  any health insurer’s proprietary or confidential information.
 1000         (5)The commission may adopt rules to implement this
 1001  section.
 1002         Section 12. Section 641.262, Florida Statutes, is created
 1003  to read:
 1004         641.262 Health maintenance organizations; prescription drug
 1005  spending reports.—
 1006         (1)As used in this section, the term:
 1007         (a)“Specialty drug” means a prescription drug on a health
 1008  maintenance organization’s formulary which is also covered under
 1009  Medicare Part D and exceeds the specialty tier cost threshold
 1010  established by the federal Centers for Medicare and Medicaid
 1011  Services.
 1012         (b)“Utilization management” means a set of formal
 1013  techniques designed to monitor the use of or evaluate the
 1014  medical necessity, appropriateness, efficacy, or efficiency of
 1015  health care services, procedures, or settings.
 1016         (2)By February 1 of each year, each health maintenance
 1017  organization shall submit to the office a report including all
 1018  of the following information across all health maintenance
 1019  contracts for the preceding calendar year:
 1020         (a)The names of the 25 most frequently prescribed
 1021  prescription drugs.
 1022         (b)The percentage of any increase in annual net spending
 1023  for prescription drugs.
 1024         (c)The percentage of any increase in premiums which was
 1025  attributable to prescription drugs.
 1026         (d)The percentage of specialty drugs with utilization
 1027  management requirements prescribed.
 1028         (e)Any premium reduction that was attributable to
 1029  specialty drug utilization management.
 1030         (3)A report submitted under this section must not disclose
 1031  the identity of a specific health maintenance contract or the
 1032  price charged for a specific prescription drug or class of
 1033  prescription drugs.
 1034         (4)By May 1 of each year, the office shall publish on its
 1035  website aggregated data from all reports it received under this
 1036  section for that year. The data from the reports may not be
 1037  published in a manner that would disclose or tend to disclose
 1038  any health maintenance organization’s proprietary or
 1039  confidential information.
 1040         (5)The commission may adopt rules to implement this
 1041  section.
 1042         Section 13. Present subsection (5) of section 641.314,
 1043  Florida Statutes, is redesignated as subsection (10) and
 1044  amended, a new subsection (5) and subsections (6) through (9)
 1045  are added to that section, and subsection (1) is amended, to
 1046  read:
 1047         641.314 Pharmacy benefit manager contracts.—
 1048         (1) As used in this section, the term:
 1049         (a) “Maximum allowable cost” means the per-unit amount that
 1050  a pharmacy benefit manager reimburses a pharmacy or pharmacist
 1051  for a generic drug, brand name drug, specialty drug, biological
 1052  product, or other prescription drug, excluding dispensing fees,
 1053  before prior to the application of copayments, coinsurance, and
 1054  other cost-sharing charges, if any.
 1055         (b)“Maximum allowable cost list” means a listing of
 1056  generic drugs, brand name drugs, specialty drugs, biological
 1057  products, or other prescription drugs or other methodology used
 1058  directly or indirectly by a pharmacy benefit manager to set the
 1059  maximum allowable costs for the drugs.
 1060         (c)“Payor” means a health plan, a health plan sponsor, a
 1061  health plan provider, or any other payor that uses pharmacy
 1062  benefit management services in this state.
 1063         (d)(b) “Pharmacy benefit manager” means an a person or
 1064  entity that performs pharmacy benefit management services for
 1065  doing business in this state which contracts to administer or
 1066  manage prescription drug benefits on behalf of a health
 1067  maintenance organization or payor to residents of this state.
 1068  The term does not include a provider as defined in s. 641.19, a
 1069  physician as defined in s. 458.305, or an osteopathic physician
 1070  as defined in s. 459.003.
 1071         (e)“Pharmacy benefit management services” means services
 1072  that:
 1073         1.Are provided, directly or through another entity, to a
 1074  health maintenance organization or payor, regardless of whether
 1075  the services provider and the health maintenance organization or
 1076  payor are related or associated by ownership, common ownership,
 1077  organization, or otherwise.
 1078         2.Include the procurement of prescription drugs to be
 1079  dispensed to patients and the administration or management of
 1080  prescription drug benefits, including, but not limited to, any
 1081  of the following:
 1082         a.A mail service pharmacy or a specialty pharmacy.
 1083         b.Claims processing, retail network management, or payment
 1084  of claims to pharmacies for dispensing drugs.
 1085         c.Clinical or other formulary or preferred-drug-list
 1086  development or management.
 1087         d.Negotiation, administration, or receipt of rebates,
 1088  discounts, payment differentials, or other incentives, to
 1089  include particular drugs in a particular category or to promote
 1090  the purchase of particular drugs.
 1091         e.Patients’ compliance, therapeutic intervention, or
 1092  generic substitution programs.
 1093         f.Disease management.
 1094         g.Drug use review, step-therapy protocol, or prior
 1095  authorization.
 1096         h.Adjudication of appeals or grievances related to
 1097  prescription drug coverage.
 1098         i.Contracts with network pharmacies.
 1099         j.Control of the cost of covered prescription drugs.
 1100         (5)A contract between a health maintenance organization or
 1101  payor and a pharmacy benefit manager must require the maximum
 1102  allowable cost list to include:
 1103         (a)Average acquisition cost, including national average
 1104  drug acquisition cost.
 1105         (b)Average manufacturer price.
 1106         (c)Average wholesale price.
 1107         (d)Brand effective rate or generic effective rate.
 1108         (e)Discount indexing.
 1109         (f)Federal upper limits.
 1110         (g)Wholesale acquisition cost.
 1111         (h)Any other item that a pharmacy benefit manager or a
 1112  health maintenance organization or payor may use to establish
 1113  reimbursement rates to a pharmacist or pharmacy for filling
 1114  prescriptions or providing other pharmacy services.
 1115         (6)A health maintenance organization that uses pharmacy
 1116  benefit management services or a payor shall have access to all
 1117  financial and utilization records, data, and information used by
 1118  the pharmacy benefit manager in relation to the pharmacy benefit
 1119  management services provided to the health maintenance
 1120  organization or payor.
 1121         (7)A pharmacy benefit manager shall:
 1122         (a)Disclose in writing to the health maintenance
 1123  organization that uses pharmacy benefit management services or
 1124  the payor any activity, policy, practice, contract, or
 1125  arrangement of the pharmacy benefit manager which directly or
 1126  indirectly presents conflicts of interest with the pharmacy
 1127  benefit manager’s relationship with, or fiduciary duty or
 1128  obligation to, the subscribers and the health maintenance
 1129  organization or payor.
 1130         (b)Report quarterly to the health maintenance organization
 1131  or payor any income resulting from pricing discounts, rebates of
 1132  any kind, inflationary payments, credits, clawbacks, fees,
 1133  grants, chargebacks, reimbursements, or other financial benefits
 1134  received by the pharmacy benefit manager from any person or
 1135  entity. The pharmacy benefit manager shall ensure that such
 1136  income and financial benefits are passed through in full, at
 1137  least quarterly, to the health maintenance organization or payor
 1138  to reduce the cost of prescription drugs and pharmacy services
 1139  to the subscribers.
 1140         (8)The department shall investigate any alleged violation
 1141  of this section.
 1142         (9)(a)A pharmacy benefit manager that violates any
 1143  provision of this section is liable for a civil fine of $10,000
 1144  for each violation and may have its registration revoked by the
 1145  department.
 1146         (b)A violation of any provision of this section which is
 1147  committed or performed with such frequency as to indicate a
 1148  general business practice is subject to the Florida Deceptive
 1149  and Unfair Trade Practices Act under part II of chapter 501.
 1150         (10)(5) This section applies to contracts entered into or
 1151  renewed on or after January 1, 2021 July 1, 2018.
 1152         Section 14. Paragraph (a) of subsection (1) of section
 1153  409.9201, Florida Statutes, is amended to read:
 1154         409.9201 Medicaid fraud.—
 1155         (1) As used in this section, the term:
 1156         (a) “Prescription drug” means any drug, including, but not
 1157  limited to, finished dosage forms or active ingredients that are
 1158  subject to, defined in, or described in s. 503(b) of the Federal
 1159  Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
 1160  499.003(17), s. 499.007(13), or s. 499.82(10).
 1161  
 1162  The value of individual items of the legend drugs or goods or
 1163  services involved in distinct transactions committed during a
 1164  single scheme or course of conduct, whether involving a single
 1165  person or several persons, may be aggregated when determining
 1166  the punishment for the offense.
 1167         Section 15. Paragraph (pp) of subsection (1) of section
 1168  458.331, Florida Statutes, is amended to read:
 1169         458.331 Grounds for disciplinary action; action by the
 1170  board and department.—
 1171         (1) The following acts constitute grounds for denial of a
 1172  license or disciplinary action, as specified in s. 456.072(2):
 1173         (pp) Applicable to a licensee who serves as the designated
 1174  physician of a pain-management clinic as defined in s. 458.3265
 1175  or s. 459.0137:
 1176         1. Registering a pain-management clinic through
 1177  misrepresentation or fraud;
 1178         2. Procuring, or attempting to procure, the registration of
 1179  a pain-management clinic for any other person by making or
 1180  causing to be made, any false representation;
 1181         3. Failing to comply with any requirement of chapter 499,
 1182  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
 1183  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
 1184  the Drug Abuse Prevention and Control Act; or chapter 893, the
 1185  Florida Comprehensive Drug Abuse Prevention and Control Act;
 1186         4. Being convicted or found guilty of, regardless of
 1187  adjudication to, a felony or any other crime involving moral
 1188  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
 1189  the courts of this state, of any other state, or of the United
 1190  States;
 1191         5. Being convicted of, or disciplined by a regulatory
 1192  agency of the Federal Government or a regulatory agency of
 1193  another state for, any offense that would constitute a violation
 1194  of this chapter;
 1195         6. Being convicted of, or entering a plea of guilty or nolo
 1196  contendere to, regardless of adjudication, a crime in any
 1197  jurisdiction of the courts of this state, of any other state, or
 1198  of the United States which relates to the practice of, or the
 1199  ability to practice, a licensed health care profession;
 1200         7. Being convicted of, or entering a plea of guilty or nolo
 1201  contendere to, regardless of adjudication, a crime in any
 1202  jurisdiction of the courts of this state, of any other state, or
 1203  of the United States which relates to health care fraud;
 1204         8. Dispensing any medicinal drug based upon a communication
 1205  that purports to be a prescription as defined in s. 465.003 s.
 1206  465.003(14) or s. 893.02 if the dispensing practitioner knows or
 1207  has reason to believe that the purported prescription is not
 1208  based upon a valid practitioner-patient relationship; or
 1209         9. Failing to timely notify the board of the date of his or
 1210  her termination from a pain-management clinic as required by s.
 1211  458.3265(3).
 1212         Section 16. Paragraph (rr) of subsection (1) of section
 1213  459.015, Florida Statutes, is amended to read:
 1214         459.015 Grounds for disciplinary action; action by the
 1215  board and department.—
 1216         (1) The following acts constitute grounds for denial of a
 1217  license or disciplinary action, as specified in s. 456.072(2):
 1218         (rr) Applicable to a licensee who serves as the designated
 1219  physician of a pain-management clinic as defined in s. 458.3265
 1220  or s. 459.0137:
 1221         1. Registering a pain-management clinic through
 1222  misrepresentation or fraud;
 1223         2. Procuring, or attempting to procure, the registration of
 1224  a pain-management clinic for any other person by making or
 1225  causing to be made, any false representation;
 1226         3. Failing to comply with any requirement of chapter 499,
 1227  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
 1228  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
 1229  the Drug Abuse Prevention and Control Act; or chapter 893, the
 1230  Florida Comprehensive Drug Abuse Prevention and Control Act;
 1231         4. Being convicted or found guilty of, regardless of
 1232  adjudication to, a felony or any other crime involving moral
 1233  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
 1234  the courts of this state, of any other state, or of the United
 1235  States;
 1236         5. Being convicted of, or disciplined by a regulatory
 1237  agency of the Federal Government or a regulatory agency of
 1238  another state for, any offense that would constitute a violation
 1239  of this chapter;
 1240         6. Being convicted of, or entering a plea of guilty or nolo
 1241  contendere to, regardless of adjudication, a crime in any
 1242  jurisdiction of the courts of this state, of any other state, or
 1243  of the United States which relates to the practice of, or the
 1244  ability to practice, a licensed health care profession;
 1245         7. Being convicted of, or entering a plea of guilty or nolo
 1246  contendere to, regardless of adjudication, a crime in any
 1247  jurisdiction of the courts of this state, of any other state, or
 1248  of the United States which relates to health care fraud;
 1249         8. Dispensing any medicinal drug based upon a communication
 1250  that purports to be a prescription as defined in s. 465.003 s.
 1251  465.003(14) or s. 893.02 if the dispensing practitioner knows or
 1252  has reason to believe that the purported prescription is not
 1253  based upon a valid practitioner-patient relationship; or
 1254         9. Failing to timely notify the board of the date of his or
 1255  her termination from a pain-management clinic as required by s.
 1256  459.0137(3).
 1257         Section 17. Subsection (1) of section 465.014, Florida
 1258  Statutes, is amended to read:
 1259         465.014 Pharmacy technician.—
 1260         (1) A person other than a licensed pharmacist or pharmacy
 1261  intern may not engage in the practice of the profession of
 1262  pharmacy, except that a licensed pharmacist may delegate to
 1263  pharmacy technicians who are registered pursuant to this section
 1264  those duties, tasks, and functions that do not fall within the
 1265  purview of s. 465.003 s. 465.003(13). All such delegated acts
 1266  must be performed under the direct supervision of a licensed
 1267  pharmacist who is responsible for all such acts performed by
 1268  persons under his or her supervision. A registered pharmacy
 1269  technician, under the supervision of a pharmacist, may initiate
 1270  or receive communications with a practitioner or his or her
 1271  agent, on behalf of a patient, regarding refill authorization
 1272  requests. A licensed pharmacist may not supervise more than one
 1273  registered pharmacy technician unless otherwise permitted by the
 1274  guidelines adopted by the board. The board shall establish
 1275  guidelines to be followed by licensees or permittees in
 1276  determining the circumstances under which a licensed pharmacist
 1277  may supervise more than one pharmacy technician.
 1278         Section 18. Paragraph (c) of subsection (2) of section
 1279  465.015, Florida Statutes, is amended to read:
 1280         465.015 Violations and penalties.—
 1281         (2) It is unlawful for any person:
 1282         (c) To sell or dispense drugs as defined in s. 465.003 s.
 1283  465.003(8) without first being furnished with a prescription.
 1284         Section 19. Subsection (9) of section 465.0156, Florida
 1285  Statutes, is amended to read:
 1286         465.0156 Registration of nonresident pharmacies.—
 1287         (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
 1288  of this section, the registered pharmacy and the pharmacist
 1289  designated by the registered pharmacy as the prescription
 1290  department manager or the equivalent must be licensed in the
 1291  state of location in order to dispense into this state.
 1292         Section 20. Paragraph (s) of subsection (1) of section
 1293  465.016, Florida Statutes, is amended to read:
 1294         465.016 Disciplinary actions.—
 1295         (1) The following acts constitute grounds for denial of a
 1296  license or disciplinary action, as specified in s. 456.072(2):
 1297         (s) Dispensing any medicinal drug based upon a
 1298  communication that purports to be a prescription as defined in
 1299  s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
 1300  knows or has reason to believe that the purported prescription
 1301  is not based upon a valid practitioner-patient relationship.
 1302         Section 21. Subsection (4) of section 465.0197, Florida
 1303  Statutes, is amended to read:
 1304         465.0197 Internet pharmacy permits.—
 1305         (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
 1306  of this section, the Internet pharmacy and the pharmacist
 1307  designated by the Internet pharmacy as the prescription
 1308  department manager or the equivalent must be licensed in the
 1309  state of location in order to dispense into this state.
 1310         Section 22. Paragraph (j) of subsection (5) of section
 1311  465.022, Florida Statutes, is amended to read:
 1312         465.022 Pharmacies; general requirements; fees.—
 1313         (5) The department or board shall deny an application for a
 1314  pharmacy permit if the applicant or an affiliated person,
 1315  partner, officer, director, or prescription department manager
 1316  or consultant pharmacist of record of the applicant:
 1317         (j) Has dispensed any medicinal drug based upon a
 1318  communication that purports to be a prescription as defined in
 1319  s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
 1320  knows or has reason to believe that the purported prescription
 1321  is not based upon a valid practitioner-patient relationship that
 1322  includes a documented patient evaluation, including history and
 1323  a physical examination adequate to establish the diagnosis for
 1324  which any drug is prescribed and any other requirement
 1325  established by board rule under chapter 458, chapter 459,
 1326  chapter 461, chapter 463, chapter 464, or chapter 466.
 1327  
 1328  For felonies in which the defendant entered a plea of guilty or
 1329  nolo contendere in an agreement with the court to enter a
 1330  pretrial intervention or drug diversion program, the department
 1331  shall deny the application if upon final resolution of the case
 1332  the licensee has failed to successfully complete the program.
 1333         Section 23. Paragraph (h) of subsection (1) of section
 1334  465.023, Florida Statutes, is amended to read:
 1335         465.023 Pharmacy permittee; disciplinary action.—
 1336         (1) The department or the board may revoke or suspend the
 1337  permit of any pharmacy permittee, and may fine, place on
 1338  probation, or otherwise discipline any pharmacy permittee if the
 1339  permittee, or any affiliated person, partner, officer, director,
 1340  or agent of the permittee, including a person fingerprinted
 1341  under s. 465.022(3), has:
 1342         (h) Dispensed any medicinal drug based upon a communication
 1343  that purports to be a prescription as defined in s. 465.003 by
 1344  s. 465.003(14) or s. 893.02 when the pharmacist knows or has
 1345  reason to believe that the purported prescription is not based
 1346  upon a valid practitioner-patient relationship that includes a
 1347  documented patient evaluation, including history and a physical
 1348  examination adequate to establish the diagnosis for which any
 1349  drug is prescribed and any other requirement established by
 1350  board rule under chapter 458, chapter 459, chapter 461, chapter
 1351  463, chapter 464, or chapter 466.
 1352         Section 24. Section 465.1901, Florida Statutes, is amended
 1353  to read:
 1354         465.1901 Practice of orthotics and pedorthics.—The
 1355  provisions of chapter 468 relating to orthotics or pedorthics do
 1356  not apply to any licensed pharmacist or to any person acting
 1357  under the supervision of a licensed pharmacist. The practice of
 1358  orthotics or pedorthics by a pharmacist or any of the
 1359  pharmacist’s employees acting under the supervision of a
 1360  pharmacist shall be construed to be within the meaning of the
 1361  term “practice of the profession of pharmacy” as defined set
 1362  forth in s. 465.003 s. 465.003(13), and shall be subject to
 1363  regulation in the same manner as any other pharmacy practice.
 1364  The Board of Pharmacy shall develop rules regarding the practice
 1365  of orthotics and pedorthics by a pharmacist. Any pharmacist or
 1366  person under the supervision of a pharmacist engaged in the
 1367  practice of orthotics or pedorthics is not precluded from
 1368  continuing that practice pending adoption of these rules.
 1369         Section 25. Subsection (40) of section 499.003, Florida
 1370  Statutes, is amended to read:
 1371         499.003 Definitions of terms used in this part.—As used in
 1372  this part, the term:
 1373         (40) “Prescription drug” means a prescription, medicinal,
 1374  or legend drug, including, but not limited to, finished dosage
 1375  forms or active pharmaceutical ingredients subject to, defined
 1376  by, or described by s. 503(b) of the federal act or s. 465.003
 1377  s. 465.003(8), s. 499.007(13), subsection (31), or subsection
 1378  (47), except that an active pharmaceutical ingredient is a
 1379  prescription drug only if substantially all finished dosage
 1380  forms in which it may be lawfully dispensed or administered in
 1381  this state are also prescription drugs.
 1382         Section 26. Paragraph (c) of subsection (24) of section
 1383  893.02, Florida Statutes, is amended to read:
 1384         893.02 Definitions.—The following words and phrases as used
 1385  in this chapter shall have the following meanings, unless the
 1386  context otherwise requires:
 1387         (24) “Prescription” includes any order for drugs or
 1388  medicinal supplies which is written or transmitted by any means
 1389  of communication by a licensed practitioner authorized by the
 1390  laws of this state to prescribe such drugs or medicinal
 1391  supplies, is issued in good faith and in the course of
 1392  professional practice, is intended to be dispensed by a person
 1393  authorized by the laws of this state to do so, and meets the
 1394  requirements of s. 893.04.
 1395         (c) A prescription for a controlled substance may not be
 1396  issued on the same prescription blank with another prescription
 1397  for a controlled substance that is named or described in a
 1398  different schedule or with another prescription for a medicinal
 1399  drug, as defined in s. 465.003 s. 465.003(8), that is not a
 1400  controlled substance.
 1401         Section 27. This act shall take effect July 1, 2020.

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