Florida Senate - 2023                                    SB 1638
       
       
        
       By Senator Simon
       
       
       
       
       
       3-00763A-23                                           20231638__
    1                        A bill to be entitled                      
    2         An act relating to coverage for clinician-administered
    3         drugs; creating s. 627.42398, F.S.; defining terms;
    4         prohibiting certain acts by insurers or pharmacy
    5         benefit managers that cover clinician-administered
    6         drugs; providing that violations are deemed unfair
    7         methods of competition and unfair practices or acts;
    8         providing an effective date.
    9          
   10  Be It Enacted by the Legislature of the State of Florida:
   11  
   12         Section 1. Section 627.42398, Florida Statutes, is created
   13  to read:
   14         627.42398 Coverage for clinician-administered drugs.—
   15         (1) As used in this section, the term:
   16         (a) “Clinician-administered drug” means a prescription drug
   17  other than a vaccine which:
   18         1. Cannot reasonably be self-administered by the patient to
   19  whom the drug is prescribed or administered by an individual
   20  other than a health care provider, or is not approved by the
   21  United States Food and Drug Administration as a self
   22  administered drug or biologic; and
   23         2. Is typically administered in a physician’s office,
   24  hospital, outpatient infusion center, or other clinical setting.
   25         (b) “Health care provider” means a health care
   26  professional, a health care facility, or an entity licensed or
   27  certified to provide health care services in this state which
   28  meets the criteria established by the Department of Health.
   29         (c) “Insurer” means an insurer as defined in s. 624.03, a
   30  multiple-employer welfare arrangement as defined in s.
   31  624.437(1), self-insurance as defined in s. 624.031, a prepaid
   32  limited health service organization as defined in s. 636.003(7),
   33  a health maintenance organization as defined in s. 641.19(12), a
   34  prepaid health clinic as defined in s. 641.402, a fraternal
   35  benefit society as defined in s. 632.601, or any health care
   36  arrangement that assumes some risk.
   37         (d) “Participating provider” means a health care provider
   38  that participates in an insurer’s network.
   39         (e) “Pharmacy benefit manager” has the same meaning as in
   40  s. 624.490.
   41         (f) “Specialty pharmacy” means a pharmacy that focuses on
   42  high-cost medications and personalized support for patients with
   43  chronic or complex conditions.
   44         (g) “White bagging” means an insurer’s policy that requires
   45  a prescription drug to be:
   46         1. Dispensed by a specialty pharmacy selected by the
   47  insurer; and
   48         2. Transported to a health care provider for administration
   49  to a patient.
   50         (2) An insurer or a pharmacy benefit manager that covers a
   51  clinician-administered drug may not do any of the following:
   52         (a) Condition, deny, or reduce payment to a participating
   53  provider for providing the covered clinician-administered drug
   54  and related services to an insured when all criteria for medical
   55  necessity are met, regardless of whether the clinician
   56  administered drug is obtained from a pharmacy selected by the
   57  insurer. For the purposes of this section, the location of
   58  receiving the physician-administered drug may not be included in
   59  the medical necessity criteria.
   60         (b) Interfere with the insured’s right to choose to obtain
   61  the covered clinician-administered drug from a participating
   62  provider or a pharmacy of choice, through inducement, steering,
   63  or financial or other incentive offers.
   64         (c) Require the covered clinician-administered drug to be
   65  dispensed by a pharmacy selected by the insurer, including, but
   66  not limited to, through white bagging.
   67         (d) If the covered clinician-administered drug is not
   68  dispensed by a pharmacy selected by the insurer or pharmacy
   69  benefit manager:
   70         1. Reimburse for the clinician-administered drug at a
   71  lesser amount than the amount that would otherwise be
   72  reimbursed;
   73         2. Limit or exclude coverage or benefits for the clinician
   74  administered drug; or
   75         3. Require a covered person to pay an additional fee, a
   76  higher copay, a higher coinsurance, a second copay, a second
   77  coinsurance, or any other form of an increased cost-sharing
   78  amount over the price paid for the clinician-administered drug
   79  if the drug is dispensed by a pharmacy selected by the insurer
   80  or pharmacy benefit manager.
   81         (e) May not require that a clinician-administered drug be
   82  administered using home infusion or require that a clinician
   83  administered drug be sent directly to a third party or to the
   84  patient for home infusion, unless the patient’s treating
   85  physician determines that home infusion of the drug will not
   86  jeopardize the health of the patient.
   87         (3) The commission of any act prohibited under this section
   88  is deemed an unfair method of competition and unfair practice or
   89  act which subjects the violation to any and all actions,
   90  remedies, and penalties provided for in part II of chapter 501.
   91         Section 2. This act shall take effect on July 1, 2023.