Florida Senate - 2022                                    SB 1574
       
       
        
       By Senator Cruz
       
       
       
       
       
       18-01118B-22                                          20221574__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug price
    3         transparency; amending s. 499.012, F.S.; prohibiting
    4         permits for prescription drug manufacturers and
    5         nonresident prescription drug manufacturers and for
    6         certain wholesale distributors of prescription drugs
    7         from being renewed unless specified requirements are
    8         met; authorizing the Department of Business and
    9         Professional Regulation to suspend or revoke
   10         manufacturer permits and wholesale distributor permits
   11         under specified circumstances; amending s. 499.0121,
   12         F.S.; defining the term “price”; providing reporting
   13         requirements for certain entities that engage in
   14         wholesale distributions of prescription drugs;
   15         authorizing the department to request certain
   16         documentation and information; requiring the
   17         department to prescribe by rule specified timeframes;
   18         authorizing the department to extend specified
   19         timeframes; specifying what constitutes violations of
   20         specified laws; providing penalties and fines for
   21         violations; providing disposition of such fines;
   22         creating s. 499.026, F.S.; providing definitions;
   23         providing requirements for notifications by
   24         manufacturers of prescription drug price increases
   25         under certain circumstances; providing reporting
   26         requirements; requiring the department to compile a
   27         list of specified drugs; authorizing the department to
   28         request certain documentation and information;
   29         requiring the department to prescribe by rule
   30         specified timeframes; authorizing the department to
   31         extend specified timeframes; providing duties of the
   32         department; specifying what constitutes violations of
   33         specified laws; prohibiting certain prescription drugs
   34         from being included in specified drug formularies;
   35         providing an exception; providing penalties and fines
   36         for violations; providing disposition of such fines;
   37         requiring the department to adopt rules; amending s.
   38         499.05, F.S.; requiring the department to adopt rules;
   39         conforming provisions to changes made by the act;
   40         amending s. 624.490, F.S.; providing definitions;
   41         providing reporting requirements for registered
   42         pharmacy benefit managers; authorizing the Office of
   43         Insurance Regulation to request certain documentation
   44         and information; requiring the Financial Services
   45         Commission to prescribe by rule specified timeframes;
   46         authorizing the office to extend specified timeframes;
   47         requiring registered pharmacy benefit managers to
   48         maintain a website for a specified purpose and to
   49         update the information on the website under certain
   50         circumstances; specifying what constitutes violations
   51         of specified laws; providing penalties and fines for
   52         violations; providing disposition of such fines;
   53         creating ss. 627.42384 and 641.3131, F.S.; requiring
   54         certain health insurers and health maintenance
   55         organizations, respectively, to submit and update
   56         contact information for single points of contact for a
   57         specified use; requiring the office to maintain and
   58         publish such points of contact; requiring such health
   59         insurers and health maintenance organizations to
   60         notify certain insureds and subscribers, respectively,
   61         within a specified timeframe of drug formulary
   62         changes; providing applicability; amending ss.
   63         627.64741, 627.6572, and 641.314, F.S.; defining the
   64         term “net price”; providing additional requirements
   65         for contracts between pharmacy benefit managers and
   66         individual health insurers, group health insurers, and
   67         health maintenance organizations, respectively;
   68         providing applicability; amending ss. 110.12315,
   69         409.815, 409.91195, 409.912, and 499.067, F.S.;
   70         conforming provisions to changes made by the act;
   71         providing an effective date.
   72          
   73  Be It Enacted by the Legislature of the State of Florida:
   74  
   75         Section 1. Paragraph (f) is added to subsection (1) of
   76  section 499.012, Florida Statutes, to read:
   77         499.012 Permit application requirements.—
   78         (1)
   79         (f)1.A permit for a prescription drug manufacturer or
   80  nonresident prescription drug manufacturer may not be renewed
   81  unless the prescription drug manufacturer or nonresident
   82  prescription drug manufacturer meets the requirements of s.
   83  499.026. The department may suspend or revoke the permit of a
   84  manufacturer that fails to comply with the requirements of s.
   85  499.026.
   86         2.A permit for a prescription drug wholesale distributor,
   87  out-of-state prescription drug wholesale distributor, retail
   88  pharmacy drug wholesale distributor, veterinary prescription
   89  drug wholesale distributor, or limited prescription drug
   90  veterinary wholesale distributor may not be renewed unless the
   91  wholesale distributor meets the requirements of s. 499.0121(16).
   92  The department may suspend or revoke the permit of a wholesale
   93  distributor that fails to comply with the requirements of s.
   94  499.0121(16).
   95         Section 2. Subsection (16) is added to section 499.0121,
   96  Florida Statutes, to read:
   97         499.0121 Storage and handling of prescription drugs;
   98  recordkeeping; prescription drug price report requirements;
   99  penalties for noncompliance.—The department shall adopt rules to
  100  implement this section as necessary to protect the public
  101  health, safety, and welfare. Such rules shall include, but not
  102  be limited to, requirements for the storage and handling of
  103  prescription drugs and for the establishment and maintenance of
  104  prescription drug distribution records.
  105         (16)PRESCRIPTION DRUG PRICE REPORT AND PENALTIES FOR
  106  NONCOMPLIANCE.—
  107         (a)As used in this subsection, the term “price” means the
  108  manufacturer’s list price for a prescription drug to wholesalers
  109  or direct purchasers in the United States, not including prompt
  110  pay or other discounts, rebates, or reductions in price, for the
  111  most recent month for which the information is available, as
  112  reported in wholesale price guides or other publications of drug
  113  or biological pricing data.
  114         (b)By July 1 of each year, each prescription drug
  115  wholesale distributor, out-of-state prescription drug wholesale
  116  distributor, retail pharmacy drug wholesale distributor,
  117  prescription drug wholesale distributor, veterinary prescription
  118  drug wholesale distributor, or limited prescription drug
  119  veterinary wholesale distributor, or each manufacturer or
  120  repackager that engages in the wholesale distribution of
  121  prescription drugs, shall submit a report to the department on
  122  each prescription drug for which the price, during the previous
  123  calendar year:
  124         1.Was $100 or more for a 30-day supply or for a course of
  125  treatment lasting less than 30 days; or
  126         2.Increased by at least 10 percent over the previous
  127  price.
  128         (c)The report must include, at a minimum, the following
  129  information:
  130         1.The name and the price at the time of the report of each
  131  prescription drug specified in paragraph (b) and the cumulative
  132  percentage price increase during the previous calendar year.
  133         2.The length of time the prescription drug has been on the
  134  market.
  135         3.The factors that contributed to the price increase.
  136         4.The name of any generic version of the prescription drug
  137  available on the market.
  138         5.The total sales revenue for the prescription drug during
  139  the previous calendar year.
  140         6.The introductory price of the prescription drug when it
  141  was approved by the United States Food and Drug Administration
  142  and the cumulative yearly increase, by calendar year, in the
  143  price of the drug during the previous 5 years or during the
  144  number of years the drug has been on the market, whichever is
  145  less.
  146         7.Any prompt pay or discount, rebate, or reduction in
  147  price provided by the reporting wholesale distributor or
  148  manufacturer or repackager that engages in the wholesale
  149  distribution of prescription drugs when selling a prescription
  150  drug to a manufacturer, pharmacy, pharmacy benefit manager, and
  151  other entities.
  152         8.The documentation necessary to support the information
  153  reported under this paragraph.
  154         (d)The department may make a written request to the
  155  reporting wholesale distributor, manufacturer, or repackager for
  156  supporting documentation or additional information concerning
  157  the report. The department shall prescribe by rule the
  158  timeframes for the department’s request for documentation or
  159  information and for the response by the reporting wholesale
  160  distributor, manufacturer, or repackager. The department may
  161  extend the timeframe, if necessary, for the response by the
  162  wholesale distributor, manufacturer, or repackager.
  163         (e)A wholesale distributor, or a manufacturer or
  164  repackager that engages in the wholesale distribution of
  165  prescription drugs, violates this subsection if the wholesale
  166  distributor, manufacturer, or repackager:
  167         1.Fails to timely submit the report required under this
  168  subsection;
  169         2.Fails to provide information required under this
  170  subsection;
  171         3.Fails to timely respond to a written request by the
  172  department with regard to the report required under this
  173  subsection; or
  174         4.Provides inaccurate or incomplete information in the
  175  report required under this subsection.
  176         (f)1.The department may deny an application for a renewal
  177  permit or registration or suspend or revoke a registration
  178  certificate or a permit of a prescription drug wholesale
  179  distributor, or a manufacturer or repackager that engages in the
  180  wholesale distribution of prescription drugs, for violating this
  181  subsection.
  182         2.a.The department may also impose an administrative fine,
  183  not to exceed $5,000 per violation per day, for a violation of
  184  this subsection or a rule adopted to administer this subsection.
  185  Each day the violation continues constitutes a separate
  186  violation, and each such separate violation is subject to a
  187  separate fine.
  188         b.In determining the amount of fine to be levied for a
  189  violation of this subsection, the department must consider the
  190  following factors:
  191         (I)The severity of the violation.
  192         (II)Any action taken by the permittee to correct the
  193  violation or to remedy complaints.
  194         (III)Any previous violation.
  195         c.All fines collected under this subparagraph shall be
  196  deposited into the Public Medical Assistance Trust Fund
  197  administered by the Agency for Health Care Administration, to be
  198  used to help the uninsured pay for health care.
  199         Section 3. Section 499.026, Florida Statutes, is created to
  200  read:
  201         499.026Prescription drug price transparency.—
  202         (1)As used in this section, the term:
  203         (a)“Agency” means the Agency for Health Care
  204  Administration.
  205         (b)“Division” means the Division of Consumer Services of
  206  the Department of Agriculture and Consumer Services.
  207         (c)“Drug” means a prescription drug.
  208         (d)“Health insurer” means a health insurer issuing major
  209  medical coverage through an individual or group policy or a
  210  health maintenance organization issuing major medical coverage
  211  through an individual or group contract, regulated under chapter
  212  627 or chapter 641.
  213         (e)“Medicaid” means the Agency for Health Care
  214  Administration Medicaid program.
  215         (f)“Office” means the Office of Insurance Regulation of
  216  the Financial Services Commission.
  217         (g)“Price” means the manufacturer’s list price for a drug
  218  to wholesalers or direct purchasers in the United States, not
  219  including prompt pay or other discounts, rebates, or reductions
  220  in price, for the most recent month for which the information is
  221  available, as reported in wholesale price guides or other
  222  publications of drug or biological pricing data.
  223         (2)(a)At least 120 days before the effective date of any
  224  single manufacturer increase of at least 10 percent in the price
  225  of a drug, a manufacturer must provide notice of the upcoming
  226  drug price increase to:
  227         1.The department, the Department of Health, the agency,
  228  the division, and the office.
  229         2.Every health insurer that covers the drug. The
  230  manufacturer shall use the contact list published by the office
  231  under ss. 627.42384 and 641.3131 to provide notice to health
  232  insurers. Notification shall be presumed to occur on the date
  233  that the manufacturer attempts to communicate with the
  234  applicable point of contact published by the office.
  235         (b)The notices must include, at a minimum, the following
  236  information:
  237         1.The name and current price of the drug.
  238         2.The date that the increase will become effective.
  239         3.The dollar amount of the intended increase in the price
  240  of the drug.
  241         4.The percentage price increase.
  242         5.A statement of whether the price increase is
  243  necessitated by a change or improvement of the drug and, if so,
  244  a description of the change or improvement.
  245         6.A description of any other factors that contributed to
  246  the price increase.
  247         7.The documentation necessary to support the information
  248  reported under subparagraphs 5. and 6.
  249         (3)(a)By July 1 of each year, a manufacturer shall submit
  250  a report to the department, the Department of Health, the
  251  agency, the division, and the office on each drug for which the
  252  price, during the previous calendar year:
  253         1.Was $100 or more for a 30-day supply or for a course of
  254  treatment lasting less than 30 days; or
  255         2.Increased by at least 10 percent over the previous price
  256  in a single manufacturer price.
  257         (b)The report must include, at a minimum, the following
  258  information:
  259         1.The name and the price at the time of the report of each
  260  drug specified in paragraph (a) and the cumulative percentage
  261  price increase during the previous calendar year.
  262         2.The length of time the drug has been on the market.
  263         3.The factors that contributed to the price increase.
  264         4. The name of any generic version of the drug available on
  265  the market.
  266         5.The research and development costs associated with the
  267  drug that were paid using public funds.
  268         6.The direct costs incurred by the manufacturer to
  269  manufacture, market, and distribute the drug and to ensure
  270  ongoing safety and effectiveness research associated with the
  271  drug.
  272         7.The total sales revenue for the drug during the previous
  273  calendar year.
  274         8.The manufacturer’s profit attributable to the drug
  275  during the previous calendar year.
  276         9.The introductory price of the drug when it was approved
  277  by the United States Food and Drug Administration and the
  278  cumulative yearly increase, by calendar year, in the price of
  279  the drug during the previous 5 years or during the number of
  280  years the drug has been on the market, whichever is less.
  281         10.The 10 highest prices paid for the drug during the
  282  previous year in other countries.
  283         11.The documentation necessary to support the information
  284  reported under this paragraph.
  285         (4)(a)Before reviewing the data in the report filed under
  286  subsection (3), the department, in consultation with the
  287  Department of Health, the agency, and the office, shall compile
  288  a list of drugs that have a significant cost to the state or
  289  that are designated as being critical to public health. Such
  290  drugs may be sourced from the Medicaid drug utilization data and
  291  drug spending data, the division’s drug spending data, and the
  292  drug spending data of health insurers and health plans and their
  293  pharmacy benefit managers.
  294         (b)After receiving the report required under subsection
  295  (3), the department:
  296         1.May make a written request to the manufacturer for
  297  supporting documentation or additional information concerning
  298  the report. The department shall prescribe by rule the
  299  timeframes for the department’s request for documentation or
  300  information and for the manufacturer’s response to the request.
  301  The department may extend the timeframe, if necessary, for the
  302  manufacturer’s response.
  303         2.Shall review the costs and the factors contributing to
  304  each drug price or drug price increase in the report.
  305         3.Shall review the price and price increase of each drug
  306  on the list compiled under paragraph (a) and each drug on the
  307  lists reported by wholesale distributors and other entities
  308  engaged in wholesale distribution of prescription drugs and by
  309  registered pharmacy benefit managers under ss. 499.0121(16) and
  310  624.490(6)(b), respectively, to make sure that any drug on the
  311  compiled and reported lists which fits the criterion in
  312  subparagraph (3)(a)1. or subparagraph (3)(a)2. is also reported
  313  by the drug’s manufacturer under subsection (3).
  314         4.Shall, in consultation with the Department of Health,
  315  the division, and the office, determine whether the manufacturer
  316  has violated this section.
  317         (5)A manufacturer violates this section if the
  318  manufacturer:
  319         (a)Fails to timely submit notices or reports required
  320  under this section;
  321         (b)Fails to provide information required under this
  322  section;
  323         (c)Fails to timely respond to a written request by the
  324  department with regard to the notices or report required under
  325  this section; or
  326         (d)Provides inaccurate or incomplete information in the
  327  notices or report required under this section.
  328         (6)A drug for which the manufacturer does not comply with
  329  the notification or reporting requirements under this section
  330  may not be included in the Medicaid’s and state group health
  331  insurance’s drug formularies unless the drug is the most
  332  clinically appropriate, clinically effective, and lowest net
  333  cost drug.
  334         (7)(a)The department may deny an application for a renewal
  335  permit or suspend or revoke a permit of a prescription drug
  336  manufacturer or nonresident prescription drug manufacturer for
  337  violating this section.
  338         (b)1.The department may also impose an administrative
  339  fine, not to exceed $5,000 per violation per day, for a
  340  violation of this section or a rule adopted under this section.
  341  Each day the violation continues constitutes a separate
  342  violation, and each such separate violation is subject to a
  343  separate fine.
  344         2.In determining the amount of fine to be levied for a
  345  violation of this section, the department, in consultation with
  346  the Department of Health, the agency, the division, and the
  347  office, must consider the following factors:
  348         a.The severity of the violation.
  349         b.Any action taken by the permittee to correct the
  350  violation or to remedy complaints.
  351         c.Any previous violation.
  352         3.All fines collected under this section shall be
  353  deposited into the Public Medical Assistance Trust Fund
  354  administered by the agency, to be used to help the uninsured pay
  355  for health care.
  356         (8)The department shall adopt rules to administer this
  357  section.
  358         Section 4. Paragraph (m) of subsection (1) of section
  359  499.05, Florida Statutes, is amended, and paragraph (o) is added
  360  to that subsection, to read:
  361         499.05 Rules.—
  362         (1) The department shall adopt rules to implement and
  363  enforce this chapter with respect to:
  364         (m) Wholesale distributor reporting requirements of s.
  365  499.0121(14) and (16) s. 499.0121(14).
  366         (o)Manufacturer notification and reporting requirements of
  367  s. 499.026(2) and (3).
  368         Section 5. Subsection (6) of section 624.490, Florida
  369  Statutes, is renumbered as subsection (7), and a new subsection
  370  (6) is added to that section, to read:
  371         624.490 Registration of pharmacy benefit managers;
  372  prescription drug price report and public access requirements;
  373  penalties for noncompliance.—
  374         (6)(a)As used in this subsection, the term:
  375         1.“Negotiated price” means the value at which a
  376  prescription drug is sold by a prescription drug manufacturer,
  377  prescription drug wholesale distributor, or pharmacy, under a
  378  prescription drug benefits coverage administered by a pharmacy
  379  benefit manager, before any tax or cost is added and any
  380  discount, rebate, or reduction in price, including a rebate
  381  offered to the pharmacy benefit manager, is subtracted.
  382         2.“Net price” means the value at which a prescription drug
  383  is sold by a prescription drug manufacturer, prescription drug
  384  wholesale distributor, or pharmacy, under a prescription drug
  385  benefits coverage administered by a pharmacy benefit manager,
  386  after all taxes and other costs are added and all discounts,
  387  rebates, and reductions in price are subtracted, including any
  388  rebate offered to the pharmacy benefit manager which is passed
  389  on to the health insurer or health maintenance organization.
  390         3.“Rebate offered to a pharmacy benefit manager” means a
  391  direct payment by a prescription drug manufacturer, prescription
  392  drug wholesale distributor, or pharmacy to a pharmacy benefit
  393  manager for a prescription drug dispensed to an insured or
  394  subscriber. Such payment serves an incentive for the pharmacy
  395  benefit manager to promote use of the prescription drug, and the
  396  pharmacy benefit manager may choose to keep the payment or to
  397  pass it on, in full or in part, to the health insurer or health
  398  maintenance organization.
  399         (b)1.By July 1 of each year, a registered pharmacy benefit
  400  manager shall submit a report to the office on each prescription
  401  drug for which the negotiated price, during the previous
  402  calendar year:
  403         a.Was $100 or more for a 30-day supply or for a course of
  404  treatment lasting less than 30 days; or
  405         b.Increased by at least 10 percent over the previous
  406  negotiated price.
  407         2.The report must include, at a minimum, the following
  408  information:
  409         a.The name and the negotiated price at the time of the
  410  report of each prescription drug specified in subparagraph 1.
  411  and the cumulative percentage negotiated price increase during
  412  the previous calendar year.
  413         b. The name of any generic version of the prescription drug
  414  available on the market.
  415         c.The total sales revenue of the pharmacy benefit manager
  416  for the prescription drug during the previous calendar year.
  417         d.The documentation necessary to support the information
  418  reported under this paragraph.
  419         3.The office may make a written request to the pharmacy
  420  benefit manager for supporting documentation or additional
  421  information concerning the report. The commission shall
  422  prescribe by rule the timeframes for the office’s request for
  423  documentation or information and for the pharmacy benefit
  424  manager’s response to the request. The office may extend the
  425  timeframe, if necessary, for the pharmacy benefit manager’s
  426  response.
  427         (c)A registered pharmacy benefit manager shall maintain a
  428  website that provides public access to the net price of each
  429  prescription drug. The registered pharmacy benefit manager shall
  430  update the net price of a prescription drug on the website at
  431  least 90 days before the net price of the prescription drug
  432  changes.
  433         (d)A registered pharmacy benefit manager violates this
  434  subsection if the registered pharmacy benefit manager:
  435         1.Fails to timely submit the report required under
  436  paragraph (b);
  437         2.Fails to provide information required under paragraph
  438  (b);
  439         3.Fails to timely respond to a written request by the
  440  office with regard to the report required under paragraph (b);
  441         4.Provides inaccurate or incomplete information in the
  442  report required under paragraph (b); or
  443         5.Fails to maintain a website for access to net prices of
  444  prescription drugs or to update the net prices on the website,
  445  as required under paragraph (c).
  446         (e)1.The office may deny an application for renewal
  447  registration or suspend or revoke a registration certificate of
  448  a pharmacy benefit manager for violating this subsection.
  449         2.a.The office may also impose an administrative fine, not
  450  to exceed $5,000 per violation per day, for a violation of this
  451  subsection or a rule adopted to administer this subsection. Each
  452  day the violation continues constitutes a separate violation,
  453  and each such separate violation is subject to a separate fine.
  454         b.In determining the amount of fine to be levied for a
  455  violation of this subsection, the office must consider the
  456  following factors:
  457         (I)The severity of the violation.
  458         (II)Any action taken by the pharmacy benefit manager to
  459  correct the violation or to remedy complaints.
  460         (III)Any previous violation.
  461         c.All fines collected under this subsection shall be
  462  deposited into the Public Medical Assistance Trust Fund
  463  administered by the Agency for Health Care Administration, to be
  464  used to help the uninsured pay for health care.
  465         Section 6. Section 627.42384, Florida Statutes, is created
  466  to read:
  467         627.42384Formulary changes resulting from drug price
  468  increases.—
  469         (1)A health insurer issuing a major medical individual or
  470  group policy shall submit, and update as necessary, contact
  471  information for a single point of contact for use by
  472  prescription drug manufacturers to comply with s. 499.026. The
  473  office shall maintain and publish on its website a list of such
  474  points of contact.
  475         (2)A health insurer issuing a major medical individual or
  476  group policy must provide written notice to each affected
  477  insured and each prescribing health care provider at least 90
  478  days before making a drug formulary change that results from a
  479  prescription drug price increase reported by a drug manufacturer
  480  under s. 499.026(2).
  481         (3)This section applies to policies entered into or
  482  renewed on or after January 1, 2023.
  483         Section 7. Paragraph (b) of subsection (1) of section
  484  627.64741, Florida Statutes, is redesignated as paragraph (c),
  485  subsection (5) is amended, a new paragraph (b) is added to
  486  subsection (1), and paragraphs (c) through (f) are added to
  487  subsection (2) of that section, to read:
  488         627.64741 Pharmacy benefit manager contracts.—
  489         (1) As used in this section, the term:
  490         (b)“Net price” means the value at which a prescription
  491  drug is sold by a prescription drug manufacturer, prescription
  492  drug wholesale distributor, or pharmacy, under a prescription
  493  drug benefits coverage administered by a pharmacy benefit
  494  manager, after all taxes and other costs are added and all
  495  discounts, rebates, and reductions in price are subtracted,
  496  including any rebate offered to the pharmacy benefit manager
  497  which is passed on to the health insurer.
  498         (2) A contract between a health insurer and a pharmacy
  499  benefit manager must require that the pharmacy benefit manager:
  500         (c)Maintain a website that provides public access to the
  501  net price of each covered prescription drug and update the net
  502  price of a covered prescription drug on the website at least 90
  503  days before the net price of the covered prescription drug
  504  changes.
  505         (d)Provide written notice to each affected insured and
  506  each prescribing health care provider at least 90 days before
  507  making a change in the drug formulary or in the net price of a
  508  covered prescription drug, including a change that results from
  509  a price increase of a covered prescription drug reported by a
  510  drug manufacturer under s. 499.026(2).
  511         (e)Inform an affected insured, in writing, of the net
  512  price of each covered prescription drug for which the insured
  513  has made a payment.
  514         (f)Provide in writing to each insured and each prescribing
  515  health care provider the address of the pharmacy benefit
  516  manager’s website where the list of the net prices of all
  517  prescription drugs is posted.
  518         (5) This section applies to contracts entered into or
  519  renewed on or after July 1, 2022 July 1, 2018.
  520         Section 8. Paragraph (b) of subsection (1) of section
  521  627.6572, Florida Statutes, is redesignated as paragraph (c),
  522  subsection (5) is amended, a new paragraph (b) is added to
  523  subsection (1), and paragraphs (c) through (f) are added to
  524  subsection (2) of that section, to read:
  525         627.6572 Pharmacy benefit manager contracts.—
  526         (1) As used in this section, the term:
  527         (b)“Net price” means the value at which a prescription
  528  drug is sold by a prescription drug manufacturer, prescription
  529  drug wholesale distributor, or pharmacy, under a prescription
  530  drug benefits coverage administered by a pharmacy benefit
  531  manager, after all taxes and other costs are added and all
  532  discounts, rebates, and reductions in price are subtracted,
  533  including any rebate offered to the pharmacy benefit manager
  534  which is passed on to the health insurer.
  535         (2) A contract between a health insurer and a pharmacy
  536  benefit manager must require that the pharmacy benefit manager:
  537         (c)Maintain a website that provides public access to the
  538  net price of each covered prescription drug and update the net
  539  price of a covered prescription drug on the website at least 90
  540  days before the net price of the covered prescription drug
  541  changes.
  542         (d)Provide written notice to each affected insured and
  543  each prescribing health care provider at least 90 days before
  544  making a change in the drug formulary or in the net price of a
  545  covered prescription drug, including a change that results from
  546  a price increase of a covered prescription drug reported by a
  547  drug manufacturer under s. 499.026(2).
  548         (e)Inform an insured, in writing, of the net price of each
  549  covered prescription drug for which the insured has made a
  550  payment.
  551         (f)Provide in writing to each insured and each prescribing
  552  health care provider the address of the pharmacy benefit
  553  manager’s website where the list of the net prices of all
  554  covered prescription drugs is posted.
  555         (5) This section applies to contracts entered into or
  556  renewed on or after July 1, 2022 July 1, 2018.
  557         Section 9. Section 641.3131, Florida Statutes, is created
  558  to read:
  559         641.3131Formulary changes resulting from drug price
  560  increases.—
  561         (1)A health maintenance organization issuing a major
  562  medical or other comprehensive coverage contract shall submit,
  563  and update as necessary, contact information for a single point
  564  of contact for use by prescription drug manufacturers to comply
  565  with s. 499.026. The office shall maintain and publish on its
  566  website a list of such points of contact.
  567         (2)A health maintenance organization issuing a major
  568  medical or other comprehensive coverage contract must provide
  569  written notice to each affected subscriber and each prescribing
  570  health care provider at least 90 days before making a drug
  571  formulary change that results from a prescription drug price
  572  increase reported by a drug manufacturer under s. 499.026(2).
  573         (3)This section applies to contracts entered into or
  574  renewed on or after January 1, 2023.
  575         Section 10. Paragraph (b) of subsection (1) of section
  576  641.314, Florida Statutes, is redesignated as paragraph (c),
  577  subsection (5) is amended, a new paragraph (b) is added to
  578  subsection (1), and paragraphs (c) through (f) are added to
  579  subsection (2) of that section, to read:
  580         641.314 Pharmacy benefit manager contracts.—
  581         (1) As used in this section, the term:
  582         (b)“Net price” means the value at which a prescription
  583  drug is sold by a prescription drug manufacturer, prescription
  584  drug wholesale distributor, or pharmacy, under a prescription
  585  drug benefits coverage administered by a pharmacy benefit
  586  manager, after all taxes and other costs are added and all
  587  discounts, rebates, and reductions in price are subtracted,
  588  including any rebate offered to the pharmacy benefit manager
  589  which is passed on to the health maintenance organization.
  590         (2) A contract between a health maintenance organization
  591  and a pharmacy benefit manager must require that the pharmacy
  592  benefit manager:
  593         (c)Maintain a website that provides public access to the
  594  net price of each covered prescription drug and update the net
  595  price of a covered prescription drug on the website at least 90
  596  days before the net price of the covered prescription drug
  597  changes.
  598         (d)Provide written notice to each affected subscriber and
  599  each prescribing health care provider at least 90 days before
  600  making a change in the drug formulary or in the net price of a
  601  covered prescription drug, including a change that results from
  602  a price increase of a covered prescription drug reported by a
  603  drug manufacturer under s. 499.026(2).
  604         (e)Inform a subscriber in writing of the net price of each
  605  covered prescription drug for which the subscriber has made a
  606  payment.
  607         (f)Provide in writing to each subscriber and each
  608  prescribing health care provider the address of the pharmacy
  609  benefit manager’s website where the list of the net prices of
  610  all prescription drugs is posted.
  611         (5) This section applies to contracts entered into or
  612  renewed on or after July 1, 2022 July 1, 2018.
  613         Section 11. Subsections (3) and (4) and paragraph (a) of
  614  subsection (9) of section 110.12315, Florida Statutes, are
  615  amended to read:
  616         110.12315 Prescription drug program.—The state employees’
  617  prescription drug program is established. This program shall be
  618  administered by the Department of Management Services, according
  619  to the terms and conditions of the plan as established by the
  620  relevant provisions of the annual General Appropriations Act and
  621  implementing legislation, subject to the following conditions:
  622         (3) The department shall maintain the generic, preferred
  623  brand name, and the nonpreferred brand name lists of drugs and
  624  supplies to be used in the administration of the state
  625  employees’ prescription drug program. These lists may not
  626  include a prescription drug for which the prescription drug
  627  manufacturer does not comply with the requirements of s. 499.026
  628  unless the prescription drug is the most clinically appropriate,
  629  clinically effective, and lowest net-cost prescription drug.
  630         (4) The department shall maintain a list of maintenance
  631  drugs and supplies. The list may not include a drug for which
  632  the prescription drug manufacturer does not comply with the
  633  requirements of s. 499.026 unless the prescription drug is the
  634  most clinically appropriate, clinically effective, and lowest
  635  net-cost prescription drug.
  636         (a) Preferred provider organization health plan members may
  637  have prescriptions for maintenance drugs and supplies filled up
  638  to three times as a supply for up to 30 days through a retail
  639  pharmacy; thereafter, prescriptions for the same maintenance
  640  drug or supply must be filled for up to 90 days either through
  641  the department’s contracted mail order pharmacy or through a
  642  retail pharmacy.
  643         (b) Health maintenance organization health plan members may
  644  have prescriptions for maintenance drugs and supplies filled for
  645  up to 90 days either through a mail order pharmacy or through a
  646  retail pharmacy.
  647         (9)(a) Beginning with the 2020 plan year, the department
  648  must implement formulary management for prescription drugs and
  649  supplies. Such management practices must require prescription
  650  drugs to be subject to formulary inclusion or exclusion and,
  651  beginning with the 2023 plan year, must require a prescription
  652  drug for which the prescription drug manufacturer does not
  653  comply with the requirements of s. 499.026 to be subject to
  654  formulary exclusion, but may not restrict access to the most
  655  clinically appropriate, clinically effective, and lowest net
  656  cost prescription drugs and supplies. Drugs excluded from the
  657  formulary must be available for inclusion if a physician,
  658  advanced practice registered nurse, or physician assistant
  659  prescribing a pharmaceutical clearly states on the prescription
  660  that the excluded drug is medically necessary. Prescription
  661  drugs and supplies first made available in the marketplace after
  662  January 1, 2020, may not be covered by the prescription drug
  663  program until specifically included in the list of covered
  664  prescription drugs and supplies.
  665         Section 12. Paragraph (n) of subsection (2) of section
  666  409.815, Florida Statutes, is amended to read:
  667         409.815 Health benefits coverage; limitations.—
  668         (2) BENCHMARK BENEFITS.—In order for health benefits
  669  coverage to qualify for premium assistance payments for an
  670  eligible child under ss. 409.810-409.821, the health benefits
  671  coverage, except for coverage under Medicaid and Medikids, must
  672  include the following minimum benefits, as medically necessary.
  673         (n) Prescribed drugs.—
  674         1. Coverage shall include drugs prescribed for the
  675  treatment of illness or injury when prescribed by a licensed
  676  health practitioner acting within the scope of his or her
  677  practice.
  678         2. Prescribed drugs may be limited to generics if available
  679  and brand name products if a generic substitution is not
  680  available, unless the prescribing licensed health practitioner
  681  indicates that a brand name is medically necessary.
  682         3. Prescribed drugs covered under this section shall
  683  include all prescribed drugs covered under the Florida Medicaid
  684  program.
  685         4.Prescribed drugs may not include a prescription drug for
  686  which the manufacturer does not comply with the requirements of
  687  s. 499.026 unless the prescription drug is the most clinically
  688  appropriate, clinically effective, and lowest net-cost
  689  prescription drug or unless a physician, advanced practice
  690  registered nurse, or physician assistant prescribing the drug
  691  clearly states on the prescription that the excluded drug is
  692  medically necessary.
  693         Section 13. Subsection (8) of section 409.91195, Florida
  694  Statutes, is amended to read:
  695         409.91195 Medicaid Pharmaceutical and Therapeutics
  696  Committee.—There is created a Medicaid Pharmaceutical and
  697  Therapeutics Committee within the agency for the purpose of
  698  developing a Medicaid preferred drug list.
  699         (8) The committee shall develop its preferred drug list
  700  recommendations by considering the clinical efficacy, safety,
  701  and cost-effectiveness of a product and the manufacturer’s
  702  prescription drug price transparency, as required under s.
  703  499.012.
  704         Section 14. Paragraph (a) of subsection (5) of section
  705  409.912, Florida Statutes, is amended to read:
  706         409.912 Cost-effective purchasing of health care.—The
  707  agency shall purchase goods and services for Medicaid recipients
  708  in the most cost-effective manner consistent with the delivery
  709  of quality medical care. To ensure that medical services are
  710  effectively utilized, the agency may, in any case, require a
  711  confirmation or second physician’s opinion of the correct
  712  diagnosis for purposes of authorizing future services under the
  713  Medicaid program. This section does not restrict access to
  714  emergency services or poststabilization care services as defined
  715  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
  716  shall be rendered in a manner approved by the agency. The agency
  717  shall maximize the use of prepaid per capita and prepaid
  718  aggregate fixed-sum basis services when appropriate and other
  719  alternative service delivery and reimbursement methodologies,
  720  including competitive bidding pursuant to s. 287.057, designed
  721  to facilitate the cost-effective purchase of a case-managed
  722  continuum of care. The agency shall also require providers to
  723  minimize the exposure of recipients to the need for acute
  724  inpatient, custodial, and other institutional care and the
  725  inappropriate or unnecessary use of high-cost services. The
  726  agency shall contract with a vendor to monitor and evaluate the
  727  clinical practice patterns of providers in order to identify
  728  trends that are outside the normal practice patterns of a
  729  provider’s professional peers or the national guidelines of a
  730  provider’s professional association. The vendor must be able to
  731  provide information and counseling to a provider whose practice
  732  patterns are outside the norms, in consultation with the agency,
  733  to improve patient care and reduce inappropriate utilization.
  734  The agency may mandate prior authorization, drug therapy
  735  management, or disease management participation for certain
  736  populations of Medicaid beneficiaries, certain drug classes, or
  737  particular drugs to prevent fraud, abuse, overuse, and possible
  738  dangerous drug interactions. The Pharmaceutical and Therapeutics
  739  Committee shall make recommendations to the agency on drugs for
  740  which prior authorization is required. The agency shall inform
  741  the Pharmaceutical and Therapeutics Committee of its decisions
  742  regarding drugs subject to prior authorization. The agency is
  743  authorized to limit the entities it contracts with or enrolls as
  744  Medicaid providers by developing a provider network through
  745  provider credentialing. The agency may competitively bid single
  746  source-provider contracts if procurement of goods or services
  747  results in demonstrated cost savings to the state without
  748  limiting access to care. The agency may limit its network based
  749  on the assessment of beneficiary access to care, provider
  750  availability, provider quality standards, time and distance
  751  standards for access to care, the cultural competence of the
  752  provider network, demographic characteristics of Medicaid
  753  beneficiaries, practice and provider-to-beneficiary standards,
  754  appointment wait times, beneficiary use of services, provider
  755  turnover, provider profiling, provider licensure history,
  756  previous program integrity investigations and findings, peer
  757  review, provider Medicaid policy and billing compliance records,
  758  clinical and medical record audits, and other factors. Providers
  759  are not entitled to enrollment in the Medicaid provider network.
  760  The agency shall determine instances in which allowing Medicaid
  761  beneficiaries to purchase durable medical equipment and other
  762  goods is less expensive to the Medicaid program than long-term
  763  rental of the equipment or goods. The agency may establish rules
  764  to facilitate purchases in lieu of long-term rentals in order to
  765  protect against fraud and abuse in the Medicaid program as
  766  defined in s. 409.913. The agency may seek federal waivers
  767  necessary to administer these policies.
  768         (5)(a) The agency shall implement a Medicaid prescribed
  769  drug spending-control program that includes the following
  770  components:
  771         1. A Medicaid preferred drug list, which shall be a listing
  772  of cost-effective therapeutic options recommended by the
  773  Medicaid Pharmacy and Therapeutics Committee established
  774  pursuant to s. 409.91195 and adopted by the agency for each
  775  therapeutic class on the preferred drug list. At the discretion
  776  of the committee, and when feasible, the preferred drug list
  777  should include at least two products in a therapeutic class. The
  778  agency may post the preferred drug list and updates to the list
  779  on an Internet website without following the rulemaking
  780  procedures of chapter 120. Drugs for which the manufacturer does
  781  not comply with the requirements of s. 499.026 are excluded from
  782  the preferred list, unless the drug is the most clinically
  783  appropriate, clinically effective, and lowest net-cost
  784  prescription drug. Antiretroviral agents are excluded from the
  785  preferred drug list. The agency shall also limit the amount of a
  786  prescribed drug dispensed to no more than a 34-day supply unless
  787  the drug products’ smallest marketed package is greater than a
  788  34-day supply, or the drug is determined by the agency to be a
  789  maintenance drug in which case a 100-day maximum supply may be
  790  authorized. The agency may seek any federal waivers necessary to
  791  implement these cost-control programs and to continue
  792  participation in the federal Medicaid rebate program, or
  793  alternatively to negotiate state-only manufacturer rebates. The
  794  agency may adopt rules to administer this subparagraph. The
  795  agency shall continue to provide unlimited contraceptive drugs
  796  and items. The agency must establish procedures to ensure that:
  797         a. There is a response to a request for prior authorization
  798  by telephone or other telecommunication device within 24 hours
  799  after receipt of a request for prior authorization; and
  800         b. A 72-hour supply of the drug prescribed is provided in
  801  an emergency or when the agency does not provide a response
  802  within 24 hours as required by sub-subparagraph a.
  803         2. A provider of prescribed drugs is reimbursed in an
  804  amount not to exceed the lesser of the actual acquisition cost
  805  based on the Centers for Medicare and Medicaid Services National
  806  Average Drug Acquisition Cost pricing files plus a professional
  807  dispensing fee, the wholesale acquisition cost plus a
  808  professional dispensing fee, the state maximum allowable cost
  809  plus a professional dispensing fee, or the usual and customary
  810  charge billed by the provider.
  811         3. The agency shall develop and implement a process for
  812  managing the drug therapies of Medicaid recipients who are using
  813  significant numbers of prescribed drugs each month. The
  814  management process may include, but is not limited to,
  815  comprehensive, physician-directed medical-record reviews, claims
  816  analyses, and case evaluations to determine the medical
  817  necessity and appropriateness of a patient’s treatment plan and
  818  drug therapies. The agency may contract with a private
  819  organization to provide drug-program-management services. The
  820  Medicaid drug benefit management program shall include
  821  initiatives to manage drug therapies for HIV/AIDS patients,
  822  patients using 20 or more unique prescriptions in a 180-day
  823  period, and the top 1,000 patients in annual spending. The
  824  agency shall enroll any Medicaid recipient in the drug benefit
  825  management program if he or she meets the specifications of this
  826  provision and is not enrolled in a Medicaid health maintenance
  827  organization.
  828         4. The agency may limit the size of its pharmacy network
  829  based on need, competitive bidding, price negotiations,
  830  credentialing, or similar criteria. The agency shall give
  831  special consideration to rural areas in determining the size and
  832  location of pharmacies included in the Medicaid pharmacy
  833  network. A pharmacy credentialing process may include criteria
  834  such as a pharmacy’s full-service status, location, size,
  835  patient educational programs, patient consultation, disease
  836  management services, and other characteristics. The agency may
  837  impose a moratorium on Medicaid pharmacy enrollment if it is
  838  determined that it has a sufficient number of Medicaid
  839  participating providers. The agency must allow dispensing
  840  practitioners to participate as a part of the Medicaid pharmacy
  841  network regardless of the practitioner’s proximity to any other
  842  entity that is dispensing prescription drugs under the Medicaid
  843  program. A dispensing practitioner must meet all credentialing
  844  requirements applicable to his or her practice, as determined by
  845  the agency.
  846         5. The agency shall develop and implement a program that
  847  requires Medicaid practitioners who issue written prescriptions
  848  for medicinal drugs to use a counterfeit-proof prescription pad
  849  for Medicaid prescriptions. The agency shall require the use of
  850  standardized counterfeit-proof prescription pads by prescribers
  851  who issue written prescriptions for Medicaid recipients. The
  852  agency may implement the program in targeted geographic areas or
  853  statewide.
  854         6. The agency may enter into arrangements that require
  855  manufacturers of generic drugs prescribed to Medicaid recipients
  856  to provide rebates of at least 15.1 percent of the average
  857  manufacturer price for the manufacturer’s generic products.
  858  These arrangements shall require that if a generic-drug
  859  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  860  at a level below 15.1 percent, the manufacturer must provide a
  861  supplemental rebate to the state in an amount necessary to
  862  achieve a 15.1-percent rebate level.
  863         7. The agency may establish a preferred drug list as
  864  described in this subsection, and, pursuant to the establishment
  865  of such preferred drug list, negotiate supplemental rebates from
  866  manufacturers that are in addition to those required by Title
  867  XIX of the Social Security Act and at no less than 14 percent of
  868  the average manufacturer price as defined in 42 U.S.C. s. 1936
  869  on the last day of a quarter unless the federal or supplemental
  870  rebate, or both, equals or exceeds 29 percent. There is no upper
  871  limit on the supplemental rebates the agency may negotiate. The
  872  agency may determine that specific products, brand-name or
  873  generic, are competitive at lower rebate percentages. Agreement
  874  to pay the minimum supplemental rebate percentage guarantees a
  875  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  876  Committee will consider a product for inclusion on the preferred
  877  drug list. However, a pharmaceutical manufacturer is not
  878  guaranteed placement on the preferred drug list by simply paying
  879  the minimum supplemental rebate. Agency decisions will be made
  880  on the clinical efficacy of a drug and recommendations of the
  881  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  882  the price of competing products minus federal and state rebates.
  883  The agency may contract with an outside agency or contractor to
  884  conduct negotiations for supplemental rebates. For the purposes
  885  of this section, the term “supplemental rebates” means cash
  886  rebates. Value-added programs as a substitution for supplemental
  887  rebates are prohibited. The agency may seek any federal waivers
  888  to implement this initiative.
  889         8.a. The agency may implement a Medicaid behavioral drug
  890  management system. The agency may contract with a vendor that
  891  has experience in operating behavioral drug management systems
  892  to implement this program. The agency may seek federal waivers
  893  to implement this program.
  894         b. The agency, in conjunction with the Department of
  895  Children and Families, may implement the Medicaid behavioral
  896  drug management system that is designed to improve the quality
  897  of care and behavioral health prescribing practices based on
  898  best practice guidelines, improve patient adherence to
  899  medication plans, reduce clinical risk, and lower prescribed
  900  drug costs and the rate of inappropriate spending on Medicaid
  901  behavioral drugs. The program may include the following
  902  elements:
  903         (I) Provide for the development and adoption of best
  904  practice guidelines for behavioral health-related drugs such as
  905  antipsychotics, antidepressants, and medications for treating
  906  bipolar disorders and other behavioral conditions; translate
  907  them into practice; review behavioral health prescribers and
  908  compare their prescribing patterns to a number of indicators
  909  that are based on national standards; and determine deviations
  910  from best practice guidelines.
  911         (II) Implement processes for providing feedback to and
  912  educating prescribers using best practice educational materials
  913  and peer-to-peer consultation.
  914         (III) Assess Medicaid beneficiaries who are outliers in
  915  their use of behavioral health drugs with regard to the numbers
  916  and types of drugs taken, drug dosages, combination drug
  917  therapies, and other indicators of improper use of behavioral
  918  health drugs.
  919         (IV) Alert prescribers to patients who fail to refill
  920  prescriptions in a timely fashion, are prescribed multiple same
  921  class behavioral health drugs, and may have other potential
  922  medication problems.
  923         (V) Track spending trends for behavioral health drugs and
  924  deviation from best practice guidelines.
  925         (VI) Use educational and technological approaches to
  926  promote best practices, educate consumers, and train prescribers
  927  in the use of practice guidelines.
  928         (VII) Disseminate electronic and published materials.
  929         (VIII) Hold statewide and regional conferences.
  930         (IX) Implement a disease management program with a model
  931  quality-based medication component for severely mentally ill
  932  individuals and emotionally disturbed children who are high
  933  users of care.
  934         9. The agency shall implement a Medicaid prescription drug
  935  management system.
  936         a. The agency may contract with a vendor that has
  937  experience in operating prescription drug management systems in
  938  order to implement this system. Any management system that is
  939  implemented in accordance with this subparagraph must rely on
  940  cooperation between physicians and pharmacists to determine
  941  appropriate practice patterns and clinical guidelines to improve
  942  the prescribing, dispensing, and use of drugs in the Medicaid
  943  program. The agency may seek federal waivers to implement this
  944  program.
  945         b. The drug management system must be designed to improve
  946  the quality of care and prescribing practices based on best
  947  practice guidelines, improve patient adherence to medication
  948  plans, reduce clinical risk, and lower prescribed drug costs and
  949  the rate of inappropriate spending on Medicaid prescription
  950  drugs. The program must:
  951         (I) Provide for the adoption of best practice guidelines
  952  for the prescribing and use of drugs in the Medicaid program,
  953  including translating best practice guidelines into practice;
  954  reviewing prescriber patterns and comparing them to indicators
  955  that are based on national standards and practice patterns of
  956  clinical peers in their community, statewide, and nationally;
  957  and determine deviations from best practice guidelines.
  958         (II) Implement processes for providing feedback to and
  959  educating prescribers using best practice educational materials
  960  and peer-to-peer consultation.
  961         (III) Assess Medicaid recipients who are outliers in their
  962  use of a single or multiple prescription drugs with regard to
  963  the numbers and types of drugs taken, drug dosages, combination
  964  drug therapies, and other indicators of improper use of
  965  prescription drugs.
  966         (IV) Alert prescribers to recipients who fail to refill
  967  prescriptions in a timely fashion, are prescribed multiple drugs
  968  that may be redundant or contraindicated, or may have other
  969  potential medication problems.
  970         10. The agency may contract for drug rebate administration,
  971  including, but not limited to, calculating rebate amounts,
  972  invoicing manufacturers, negotiating disputes with
  973  manufacturers, and maintaining a database of rebate collections.
  974         11. The agency may specify the preferred daily dosing form
  975  or strength for the purpose of promoting best practices with
  976  regard to the prescribing of certain drugs as specified in the
  977  General Appropriations Act and ensuring cost-effective
  978  prescribing practices.
  979         12. The agency may require prior authorization for
  980  Medicaid-covered prescribed drugs. The agency may prior
  981  authorize the use of a product:
  982         a. For an indication not approved in labeling;
  983         b. To comply with certain clinical guidelines; or
  984         c. If the product has the potential for overuse, misuse, or
  985  abuse.
  986  
  987  The agency may require the prescribing professional to provide
  988  information about the rationale and supporting medical evidence
  989  for the use of a drug. The agency shall post prior
  990  authorization, step-edit criteria and protocol, and updates to
  991  the list of drugs that are subject to prior authorization on the
  992  agency’s Internet website within 21 days after the prior
  993  authorization and step-edit criteria and protocol and updates
  994  are approved by the agency. For purposes of this subparagraph,
  995  the term “step-edit” means an automatic electronic review of
  996  certain medications subject to prior authorization.
  997         13. The agency, in conjunction with the Pharmaceutical and
  998  Therapeutics Committee, may require age-related prior
  999  authorizations for certain prescribed drugs. The agency may
 1000  preauthorize the use of a drug for a recipient who may not meet
 1001  the age requirement or may exceed the length of therapy for use
 1002  of this product as recommended by the manufacturer and approved
 1003  by the Food and Drug Administration. Prior authorization may
 1004  require the prescribing professional to provide information
 1005  about the rationale and supporting medical evidence for the use
 1006  of a drug.
 1007         14. The agency shall implement a step-therapy prior
 1008  authorization approval process for medications excluded from the
 1009  preferred drug list. Medications listed on the preferred drug
 1010  list must be used within the previous 12 months before the
 1011  alternative medications that are not listed. The step-therapy
 1012  prior authorization may require the prescriber to use the
 1013  medications of a similar drug class or for a similar medical
 1014  indication unless contraindicated in the Food and Drug
 1015  Administration labeling. The trial period between the specified
 1016  steps may vary according to the medical indication. The step
 1017  therapy approval process shall be developed in accordance with
 1018  the committee as stated in s. 409.91195(7) and (8). A drug
 1019  product may be approved without meeting the step-therapy prior
 1020  authorization criteria if the prescribing physician provides the
 1021  agency with additional written medical or clinical documentation
 1022  that the product is medically necessary because:
 1023         a. There is not a drug on the preferred drug list to treat
 1024  the disease or medical condition which is an acceptable clinical
 1025  alternative;
 1026         b. The alternatives have been ineffective in the treatment
 1027  of the beneficiary’s disease; or
 1028         c. Based on historic evidence and known characteristics of
 1029  the patient and the drug, the drug is likely to be ineffective,
 1030  or the number of doses have been ineffective.
 1031  
 1032  The agency shall work with the physician to determine the best
 1033  alternative for the patient. The agency may adopt rules waiving
 1034  the requirements for written clinical documentation for specific
 1035  drugs in limited clinical situations.
 1036         15. The agency shall implement a return and reuse program
 1037  for drugs dispensed by pharmacies to institutional recipients,
 1038  which includes payment of a $5 restocking fee for the
 1039  implementation and operation of the program. The return and
 1040  reuse program shall be implemented electronically and in a
 1041  manner that promotes efficiency. The program must permit a
 1042  pharmacy to exclude drugs from the program if it is not
 1043  practical or cost-effective for the drug to be included and must
 1044  provide for the return to inventory of drugs that cannot be
 1045  credited or returned in a cost-effective manner. The agency
 1046  shall determine if the program has reduced the amount of
 1047  Medicaid prescription drugs which are destroyed on an annual
 1048  basis and if there are additional ways to ensure more
 1049  prescription drugs are not destroyed which could safely be
 1050  reused.
 1051         Section 15. Subsection (9) of section 499.067, Florida
 1052  Statutes, is amended to read:
 1053         499.067 Denial, suspension, or revocation of permit,
 1054  certification, or registration.—
 1055         (9)(a) The department may deny, suspend, or revoke a permit
 1056  under this part if it finds the permittee has not complied with
 1057  the reporting requirements of, or knowingly made a false
 1058  statement in a report required by, s. 499.0121(14).
 1059         (b)The department may deny an application for a renewal
 1060  permit or suspend or revoke a permit if it finds the permittee
 1061  has not complied with the reporting requirements of, or
 1062  knowingly made a false statement in a report required by, s.
 1063  499.0121(16).
 1064         (c)The department may deny an application for a renewal
 1065  permit or suspend or revoke a permit if it finds the permittee
 1066  has not complied with the notification or reporting requirements
 1067  of, or knowingly made a false statement in a notice or report
 1068  required by, s. 499.026(2) or (3), respectively.
 1069         Section 16. This act shall take effect July 1, 2022.