Florida Senate - 2024                                    SB 1750
       
       
        
       By Senator Gruters
       
       
       
       
       
       22-01113B-24                                          20241750__
    1                        A bill to be entitled                      
    2         An act relating to international drug reference
    3         pricing; creating s. 499.044, F.S.; providing
    4         legislative policy; requiring prescription drug
    5         manufacturer permitholders to annually report certain
    6         international price data to the Agency for Health Care
    7         Administration; providing for administrative
    8         enforcement by a specified fine and permit suspension;
    9         requiring the agency to contract with an entity to
   10         designate reference price source countries and
   11         establish the reference prices for prescription drugs
   12         based on certain criteria; requiring the agency
   13         contractor to reevaluate the designated reference
   14         prices source countries annually and revise, as
   15         needed; requiring the agency contractor to weigh the
   16         reference price benchmark value of such countries in
   17         two or more tiers, using specified criteria; providing
   18         applicability; defining the term “real gross domestic
   19         product per capita”; requiring the agency contractor
   20         to analyze specified data to compare prices among
   21         source countries using a specified exchange rate
   22         source; requiring the agency contractor to establish
   23         the reference price for prescribed drugs or products;
   24         requiring that such price be the lowest price after
   25         making certain adjustments; requiring the agency
   26         contractor to update the reference prices annually and
   27         permitting reevaluation and updates at any time in
   28         certain circumstances; requiring the agency contractor
   29         to provide the reference prices by a specified date
   30         each year; requiring the agency to publish the prices
   31         online within a specified time; amending s. 465.0244,
   32         F.S.; requiring pharmacies to charge no more than the
   33         reference price for cash-paying patients; providing
   34         applicability; amending s. 627.6044, F.S.; requiring
   35         certain health insurers to provide reimbursement for
   36         certain prescription drugs no higher than the
   37         reference price; providing applicability; requiring
   38         health insurers to use certain savings to offset
   39         certain payer costs; requiring each health insurer to
   40         document anticipated savings and premium reductions in
   41         rate filings following the availability of reference
   42         prices; requiring each health insurer to assess the
   43         actuarial effect of the reference pricing program for
   44         each insurer product for each plan year; requiring
   45         each health insurer to submit an annual report on the
   46         assessed effect of such program to the Office of
   47         Insurance Regulation or the Agency for Health Care
   48         Administration; providing applicability; requiring the
   49         Office of Insurance Regulation and the Agency for
   50         Health Care Administration to annually submit a joint
   51         report to the Governor and the Legislature by a
   52         specified date; amending s. 641.30, F.S.; requiring
   53         every health maintenance organization to comply with
   54         the provisions of a specified section; providing an
   55         effective date.
   56          
   57  Be It Enacted by the Legislature of the State of Florida:
   58  
   59         Section 1. Section 499.044, Florida Statutes, is created to
   60  read:
   61         499.044International Drug Reference Pricing.—
   62         (1)It is the policy of the state that patients and third
   63  party payers in the state should not pay more for prescription
   64  drugs than those in international markets.
   65         (2)Beginning October 1, 2025, each prescription drug
   66  manufacturer permitholder and nonresident prescription drug
   67  manufacturer permitholder shall annually report international
   68  prescription drug price data to the Agency for Health Care
   69  Administration.
   70         (a)Permitholders shall report the actual outpatient
   71  payment or reimbursement amounts for each prescribed drug in
   72  each reference price source country identified under this
   73  subsection, including amounts paid by both third- party payers
   74  such as insurers and government benefit programs and by
   75  individual consumers not using third-party payers, net of
   76  rebates and other forms of discounts. Permitholders may report
   77  the average payment amounts for each drug for a reference price
   78  source country, if weighted by utilization volume and fully
   79  documented to the agency.
   80         (b)Permitholders may provide supplemental pricing data at
   81  any time during the year, based on a pricing in a reference
   82  price source country.
   83         (c)Permitholders shall report the data in a format
   84  established by the agency in consultation with the contractor
   85  established under this subsection.
   86         (d)Failure to timely report required data shall result in
   87  a fine of $10,000 a day for the first 30 days, and permit
   88  suspension thereafter until compliance is achieved.
   89         (3)The agency shall contract with an entity to designate
   90  reference price source countries and analyze the data submitted
   91  under subsection (2) to establish the reference price for each
   92  prescribed drug or product. The agency contractor shall
   93  reevaluate the designated reference price source countries
   94  annually and revise, as needed. The agency contractor shall
   95  weigh the reference price benchmark value of the selected
   96  reference price source countries in two or more tiers, using an
   97  established index measuring the level of health care system
   98  market orientation in each country.
   99         (a)Reference price source countries shall include only
  100  countries with a real gross domestic product per capita of at
  101  least 40 percent of the United States gross domestic product per
  102  capita, using international sales, volume, and pricing data for
  103  each country. For the purposes of this subsection, “real gross
  104  domestic product per capita” means a country’s most recent
  105  estimate based on purchasing power parity for that country
  106  available in the most recent edition of the United States
  107  Central Intelligence Agency World Factbook. Countries with
  108  single-payer health systems, which include whole-market
  109  government price-setting for prescription drugs, shall be
  110  excluded.
  111         (b)The agency contractor shall analyze the data submitted
  112  under subsection (2) to compare prices among source countries
  113  using a publicly available, reliable, and consistent exchange
  114  rate source. The agency contractor shall establish the reference
  115  price for each prescribed drug or product, which shall be the
  116  lowest price, after adjusting for volume and difference in
  117  national gross domestic product, identified in the source
  118  countries. The agency contractor shall update the reference
  119  prices annually, and may reevaluate and update a specific
  120  reference price at any time based on a significant change
  121  documented by supplemental pricing data submitted by a
  122  manufacturer under paragraph (2)(b).
  123         (c)The agency contractor shall provide the reference
  124  prices no later than January 1 each year, and the agency shall
  125  publish the reference prices online within 10 days of receipt.
  126         Section 2. Subsection (3) is added to section 465.0244,
  127  Florida Statutes, to read:
  128         465.0244 Information disclosure and reference pricing.—
  129         (3)A pharmacy shall charge a cash-paying patient an amount
  130  no greater than the reference price for a prescribed drug or
  131  product with a reference price established under s. 499.044.
  132  This requirement applies to product reimbursement, and does not
  133  apply to any dispensing fee.
  134         Section 3. Subsections (3) and (4) are added to section
  135  627.6044, Florida Statutes, to read:
  136         627.6044 Use of a specific methodology for payment of
  137  claims.—
  138         (3)A health insurer, as defined by s. 627.4301, which
  139  provides coverage for outpatient prescribed drugs and products
  140  shall provide reimbursement for a covered prescribed drug for
  141  which there is a reference price under s. 499.044 in an amount
  142  no greater than the reference price. This subsection applies to
  143  product reimbursement, and does not apply to any covered
  144  dispensing or administering fee established under the terms of
  145  the provider contract.
  146         (a)Savings generated by this subsection must be used to
  147  reduce policyholder cost sharing and premiums. Each health
  148  insurer shall document anticipated savings and premium
  149  reductions in rate filings beginning with the first rate filing
  150  following the availability of reference prices under s. 499.044.
  151         (b)Each health insurer shall assess the actuarial effect
  152  of the reference pricing program in s. 499.044 for each insurer
  153  product for each plan year. Beginning April 1 following the
  154  first full plan year in which reference prices under s. 499.044
  155  apply to prescription drug reimbursement, each health insurer
  156  shall submit an annual report on the assessed effect to the
  157  Office of Insurance Regulation or the Agency for Health Care
  158  Administration, as applicable.
  159         (c)The requirements of this subsection apply to
  160  prescription drug coverage in the Medicaid program established
  161  in chapter 409 to the extent a reference price established under
  162  s. 499.044 generates greater savings for the program than that
  163  provided by the state supplemental rebate program established
  164  under s. 409.912.
  165         (d)The requirements of this subsection apply to
  166  prescription drug coverage in the state group insurance
  167  established by part I of chapter 110.
  168         (4)Beginning January 1, 2026, and annually thereafter, the
  169  Office of Insurance Regulation and the Agency for Health Care
  170  Administration shall submit a joint report to the Governor, the
  171  President of the Senate, and the Speaker of the House of
  172  Representatives detailing the impact of subsection (3) in the
  173  preceding year, including savings realized compared to
  174  prescription drug pricing in the United States not using this
  175  pricing model, any problems encountered, barriers to access to
  176  prescription drugs, domestic and foreign prescription drug
  177  market response, monitoring and evaluating the impact on
  178  prescription drug program or plan beneficiary access, quality of
  179  care, and program costs.
  180         Section 4. Subsection (6) is added to section 641.30,
  181  Florida Statutes, to read:
  182         641.30 Construction and relationship to other laws.—
  183         (6)Every health maintenance organization must comply with
  184  s. 627.6044(3).
  185         Section 5. This act shall take effect July 1, 2024.