Florida Senate - 2024                                    SB 1608
       
       
        
       By Senator Brodeur
       
       
       
       
       
       10-01570A-24                                          20241608__
    1                        A bill to be entitled                      
    2         An act relating to prohibitions related to 340B drugs;
    3         creating s. 626.8829, F.S.; defining terms;
    4         prohibiting certain actions by health insurance
    5         issuers, pharmacy benefit managers, or other third
    6         party payors, or their agents, relating to
    7         reimbursement to a 340B entity for 340B drugs;
    8         providing applicability; prohibiting certain actions
    9         by manufacturers relating to interference with the
   10         acquisition of a 340B drug; prohibiting a
   11         manufacturer’s interference with a pharmacy’s right to
   12         contract with a 340B entity; providing that each
   13         commission of certain acts constitutes a violation of
   14         the Florida Deceptive and Unfair Trade Practices Act
   15         and subjects the violator to certain actions and
   16         penalties; providing that each commission of a
   17         prohibited act constitutes a violation of the Florida
   18         Deceptive and Unfair Trade Practices Act; providing an
   19         effective date.
   20          
   21  Be It Enacted by the Legislature of the State of Florida:
   22  
   23         Section 1. Section 626.8829, Florida Statutes, is created
   24  to read:
   25         626.8829 Prohibitions related to 304B drugs.—
   26         (1)As used in this subsection, the terms:
   27         (a)“340B drug” means a drug that has been subject to any
   28  offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
   29  s. 256b and is purchased by a covered entity as defined in 42
   30  U.S.C. s. 256b(a)(4).
   31         (b)“340B entity” means an entity participating or
   32  authorized to participate in the federal 340B Drug Discount
   33  Program, as described in 42 U.S.C. s. 256b, including its
   34  pharmacy, or any pharmacy contracted with the participating
   35  entity to dispense drugs purchased through the 340B Drug
   36  Discount Program.
   37         (c)“Health insurance issuer” means an entity subject to
   38  the insurance laws and regulations of this state, or subject to
   39  the jurisdiction of the commissioner, which contracts or offers
   40  to contract, or enters into an agreement to provide, deliver,
   41  arrange for, pay for, or reimburse any of the costs of health
   42  care services, including a sickness and accident insurance
   43  company, a health maintenance organization, a preferred provider
   44  organization or any similar entity, or any other entity
   45  providing a plan of health insurance or health benefits.
   46         (d)“Manufacturer” means any person that is a manufacturer
   47  of a prescription drug and that manufactures or distributes such
   48  prescription drug in this state.
   49         (e)“Pharmacy” has the same meaning as in s. 465.003.
   50         (f)“Pharmacy benefit manager” has the same meaning as in
   51  s. 626.88.
   52         (2)With respect to reimbursement to a 340B entity for 340B
   53  drugs, a health insurance issuer, pharmacy benefit manager, or
   54  other third-party payor, or their agents, may not do any of the
   55  following:
   56         (a)Reimburse a 340B entity for 340B drugs at a rate lower
   57  than that paid for the same drug to non-340B entities or
   58  entities owned or operated by the pharmacy benefit manager or
   59  lower reimbursement for a claim on the basis that the claim is
   60  for a 340B drug.
   61         (b)Impose any terms or conditions on any 340B entity which
   62  differ from such terms or conditions applied to non-340B
   63  entities on the basis that the entity participates in the
   64  federal 340B Drug Discount Program set forth in 42 U.S.C. s.
   65  256b or that a drug is a 340B drug, including, but not limited
   66  to, any of the following terms or conditions related to:
   67         1.Fees, charges, clawbacks, or other adjustments or
   68  assessments. For purposes of this subsection, the term “other
   69  adjustments” includes, but is not limited to, placing any
   70  additional requirements, restrictions, or unnecessary burdens on
   71  the 340B entity which result in administrative costs or fees to
   72  the 340B entity which are not placed on non-340B entities,
   73  including affiliate pharmacies of the health insurance issuer,
   74  pharmacy benefit manager, or other third-party payor.
   75         2.Dispensation of fees that are less than such fees for
   76  non-340B entities.
   77         3.Restrictions or requirements regarding participation in
   78  standard or preferred pharmacy networks.
   79         4.Requirements relating to the frequency or scope of
   80  audits of inventory management systems.
   81         5.Requirements that a claim for a drug include any
   82  identification, billing modifier, attestation, or other
   83  indication that a drug is a 340B drug in order to be processed
   84  or resubmitted unless it is required by the Centers for Medicare
   85  and Medicaid Services or the Agency for Health Care
   86  Administration for the administration of the Florida Medicaid
   87  program.
   88         6.Any other restrictions, conditions, practices, or
   89  policies that are not imposed on non-340B entities.
   90         (c)Require a 340B entity to reverse, resubmit, or clarify
   91  a claim after the initial adjudication unless these actions are
   92  in the normal course of pharmacy business and not related to
   93  340B drug pricing.
   94         (d)Base an action or contract requirement solely on the
   95  basis that the entity is a participant in the 340B drug discount
   96  program in such a manner that prevents or interferes with any
   97  patient's choice to receive such drugs from the 340B entity or
   98  its contracted pharmacy, including the creation of a restriction
   99  or additional charge on a patient who chooses to receive drugs
  100  from a 340B entity through direct dispensing, delivery, mail
  101  order, or administration of such drugs, regardless of the type
  102  of insurance coverage or medication. For purposes of this
  103  paragraph, it is considered a prohibited practice that prevents
  104  or interferes with a patient’s choice to receive drugs at a 340B
  105  entity if a health insurance issuer, pharmacy benefit manager,
  106  or other third-party payor places any additional requirements,
  107  restrictions, or unnecessary burdens on the 340B entity beyond
  108  that of any other pharmacy dispensing medications within the
  109  scope of Florida law, including, but not limited to, requiring a
  110  claim for a drug to include any identification, billing
  111  modifier, attestation, or other indication that a drug is a 340B
  112  drug in order to be processed or resubmitted unless it is
  113  required by the Centers for Medicare and Medicaid Services or
  114  the Agency for Health Care Administration in administration of
  115  the Florida Medicaid program.
  116         (e)Require or compel the submission of ingredient costs or
  117  pricing data pertaining to 340B drugs to any health insurance
  118  issuer, pharmacy benefit manager, or other third-party payor.
  119         (f)Exclude any 340B entity from the health insurance
  120  issuer, pharmacy benefit manager, or other third-party payor
  121  network on the basis that the 340B entity dispenses drugs
  122  subject to an agreement under 42 U.S.C. s. 256b, or refuse to
  123  contract with a 340B entity for reasons other than those that
  124  apply equally to non-340B entities.
  125         (3)Subsection (2) does not apply to the Florida Medicaid
  126  program as payor when Medicaid provides reimbursement for
  127  covered outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
  128         (4)A manufacturer may not deny, restrict, prohibit, or
  129  otherwise interfere with, either directly or indirectly, the
  130  acquisition of a 340B drug by, or delivery of a 340B drug to, a
  131  pharmacy that is under contract with a 340B entity and is
  132  authorized under such contract to receive and dispense 340B
  133  drugs on behalf of the covered entity unless such receipt is
  134  prohibited by the United States Department of Health and Human
  135  Services.
  136         (5)A manufacturer may not interfere with a pharmacy’s
  137  right to contract with a 340B entity.
  138         (6)The commission of any act prohibited by this section is
  139  a deceptive and unfair trade practice, constitutes a violation
  140  of the Florida Deceptive and Unfair Trade Practices Act under
  141  part II of chapter 501, and subjects the violator to all
  142  actions, including, but not limited to, investigative demands,
  143  remedies, and penalties provided for in the Florida Deceptive
  144  and Unfair Trade Practices Act. Each commission of a prohibited
  145  act constitutes a violation of the Florida Deceptive and Unfair
  146  Trade Practices Act.
  147         Section 2. This act shall take effect July 1, 2024.