Florida Senate - 2025                                    SB 1676
       
       
        
       By Senator Smith
       
       
       
       
       
       17-00656C-25                                          20251676__
    1                        A bill to be entitled                      
    2         An act relating to diabetes management; creating s.
    3         385.2035, F.S.; requiring the Department of Health to
    4         create and maintain a website; specifying requirements
    5         for such website; requiring federally qualified health
    6         centers or covered entities to make a good faith
    7         effort to schedule appointments within a specified
    8         timeline; authorizing the department to adopt rules;
    9         amending s. 465.0275, F.S.; defining terms;
   10         authorizing a pharmacist to prescribe and dispense a
   11         30-day supply of insulin drugs, glucagon drugs,
   12         diabetes devices, and diabetic ketoacidosis devices
   13         under certain circumstances; prohibiting a pharmacist
   14         from requiring patients to pay more than a certain
   15         amount for such drugs and devices; requiring
   16         pharmacists to provide a specified website address to
   17         certain patients; providing construction; requiring
   18         the department to provide a certain notice to all
   19         pharmacists; creating ss. 627.64081, 627.65746, and
   20         641.31078, F.S.; defining terms; requiring health
   21         insurance policies and health maintenance contracts,
   22         respectively, to provide coverage for laboratory and
   23         diagnostic testing and screening for diabetes under
   24         certain circumstances; prohibiting health insurance
   25         policy and health maintenance contracts from exposing
   26         certain cost-sharing requirements; providing
   27         applicability; amending s. 893.055, F.S.; requiring a
   28         dispenser to report to the electronic health
   29         recordkeeping system certain drugs and devices
   30         dispensed; defining terms; providing an effective
   31         date.
   32          
   33  Be It Enacted by the Legislature of the State of Florida:
   34  
   35         Section 1. Section 385.2035, Florida Statutes, is created
   36  to read:
   37         385.2035 Website for persons referred to a federally
   38  qualified health center.—
   39         (1)The Department of Health shall create and maintain a
   40  website to collect information from, and provide information to,
   41  persons who may benefit from referrals to a federally qualified
   42  health center, including persons who were provided the website
   43  address under s. 465.0275(3)(d). The website must, at a minimum,
   44  do all of the following:
   45         (a)Allow persons to submit their name, address, age,
   46  contact details, income, race, diabetes diagnosis status, and
   47  prescribed outpatient diabetes medications.
   48         (b)Enable the department to do all of the following:
   49         1.Determine whether the listed medications are covered
   50  outpatient drugs available at a reduced cost through a federally
   51  qualified health center or another covered entity.
   52         2.Provide persons with the name, address, and phone number
   53  of relevant federally qualified health centers or other covered
   54  entities and general information about health care services
   55  available at these centers, including how to access primary
   56  care.
   57         3.Share a person’s name, contact details, and referral
   58  status with the recommended federally qualified health center or
   59  covered entity.
   60         (2)Each federally qualified health center or covered
   61  entity that receives a person’s name, contact information, and
   62  referral from the Department of Health must make a good faith
   63  effort to schedule an appointment for that person within 30 days
   64  after receiving the information.
   65         (3)The Department of Health may adopt rules to implement
   66  this section.
   67         Section 2. Subsection (3) is added to section 465.0275,
   68  Florida Statutes, to read:
   69         465.0275 Emergency prescription refill.—
   70         (3)(a)As used in this subsection, the term:
   71         1.“Diabetes device” means a device, including, but not
   72  limited to, a blood glucose test strip, a glucometer, a
   73  continuous glucometer, a lancet, a lancing device, or an insulin
   74  syringe, used to cure, diagnose, mitigate, prevent, or treat
   75  diabetes or low blood sugar.
   76         2.“Diabetic ketoacidosis device” means a device used to
   77  screen for or prevent diabetic ketoacidosis.
   78         3.“Glucagon drug” means a drug that contains glucagon
   79  which is prescribed for self-administration on an outpatient
   80  basis and approved by the federal Food and Drug Administration
   81  to treat low blood sugar.
   82         4.“Insulin drug” means a drug, including, but not limited
   83  to, an insulin pen, which contains insulin and is prescribed for
   84  self-administration on an outpatient basis and approved by the
   85  federal Food and Drug Administration to treat diabetes.
   86         (b)Notwithstanding subsections (1) and (2), if a patient
   87  informs a pharmacist that he or she has less than a 7-day supply
   88  of any insulin drug, glucagon drug, diabetes device, or diabetic
   89  ketoacidosis device, the pharmacist may immediately prescribe
   90  and dispense up to a 30-day supply of such drugs or devices if
   91  all of the following conditions are met:
   92         1.In the pharmacist’s professional judgment, the patient
   93  is likely to suffer significant physical harm within 7 days if
   94  the drugs or devices are not obtained.
   95         2.a.The pharmacist has reviewed the prescription drug
   96  monitoring program pursuant to s. 893.055 and determined that no
   97  pharmacist has prescribed the drugs or devices to the patient
   98  within the past 12 months;
   99         b.The pharmacist has contacted the pharmacy that filled
  100  the patient’s most recent prescription for the drugs or devices
  101  and has confirmed that that no pharmacist has prescribed the
  102  drugs or devices to the patient within the past 12 months; or
  103         c.The electronic prescription drug monitoring program is
  104  unavailable.
  105         3.No later than 72 hours after the pharmacist dispenses
  106  the drugs or devices, the pharmacist or the pharmacist’s
  107  representative provides notice to the practitioner who, other
  108  than the pharmacist, most recently prescribed the drugs or
  109  devices to the patient.
  110         4.The patient pays for, or has health insurance coverage
  111  for, the drugs or devices.
  112         (c)A pharmacist who prescribes and dispenses the drugs and
  113  devices as described under this subsection may not require the
  114  patient to pay more than the amount the coinsurance, copayment,
  115  deductible, or other out-of-pocket expense that the patient’s
  116  health insurance coverage imposes or, if the patient does not
  117  have health insurance, the usual customary charge for the drugs
  118  or devices.
  119         (d)If a patient requests drugs or devices under this
  120  subsection and the pharmacist determines that the patient does
  121  not have health insurance coverage for the drugs or devices or
  122  the patient informs the pharmacist that the patient is concerned
  123  that the net cost to the patient for such supply of the drugs or
  124  devices is unaffordable, the pharmacist must provide such
  125  patient the Department of Health’s website address as specified
  126  in s. 385.2035.
  127         (e)This subsection may not be construed to prohibit a
  128  pharmacist from requiring a patient to submit to the pharmacist,
  129  before the pharmacist prescribes or dispenses a supply of the
  130  drugs or devices, proof of health insurance coverage for the
  131  patient, personal identification for the patient, contact
  132  information for a health care provider providing treatment to
  133  the patient, information concerning previous prescriptions
  134  issued to the patient for the insulin drug, glucagon drug,
  135  diabetes devices or diabetic ketoacidosis device, a sworn
  136  statement by the patient stating that the patient is unable to
  137  timely obtain the insulin drug, glucagon drug, diabetes device,
  138  or diabetic ketoacidosis device that the patient is seeking
  139  pursuant to this subsection without suffering significant
  140  physical harm, and any amount required by the pharmacist under
  141  paragraph (b).
  142         (f)No later than October 1, 2025, the department must
  143  provide notice to all pharmacists regarding the requirements of
  144  this section.
  145         Section 3. Section 627.64081, Florida Statutes, is created
  146  to read:
  147         627.64081Coverage for diabetes drugs and devices.—
  148         (1)As used in this section, the term:
  149         (a)“Cost-sharing requirement” means an insured’s
  150  deductible, coinsurance, copayment, or similar out-of-pocket
  151  expense.
  152         (b)“Diabetes device” means a device, including, but not
  153  limited to, a blood glucose test strip, a glucometer, a
  154  continuous glucometer, a lancet, a lancing device, or an insulin
  155  syringe, used to cure, diagnose, mitigate, prevent, or treat
  156  diabetes or low blood sugar.
  157         (c)“Diabetic ketoacidosis device” means a device that is
  158  used to screen for or prevent diabetic ketoacidosis.
  159         (d)“Glucagon drug” means a drug that contains glucagon
  160  which is prescribed for self-administration on an outpatient
  161  basis and approved by the federal Food and Drug Administration
  162  to treat low blood sugar.
  163         (e)“Insulin drug” means a drug, including, but not limited
  164  to, an insulin pen, which contains insulin and is prescribed for
  165  self-administration on an outpatient basis and approved by the
  166  federal Food and Drug Administration to treat diabetes.
  167         (f)“Laboratory and diagnostic testing and screening for
  168  diabetes” includes hemoglobin A1C testing and retinopathy
  169  screening.
  170         (g)“Noninsulin drug” means a drug, including, but not
  171  limited to, a glucagon drug, glucose tablet or glucose gel, that
  172  does not contain insulin and is approved by the federal Food and
  173  Drug Administration to treat diabetes.
  174         (2)A health insurance policy must provide coverage for
  175  laboratory and diagnostic testing and screening for diabetes if
  176  such testing and screening is covered under the policy, subject
  177  to the same policy provisions that apply to other covered
  178  services.
  179         (3)A health insurance policy may not impose a cost-sharing
  180  requirement that exceeds $35 for a 30-day supply of an insulin,
  181  noninsulin, or glucagon drug or $100 for a 30-day supply of all
  182  medically necessary covered diabetes and diabetic ketoacidosis
  183  devices.
  184         (4)This section applies to all health insurance policies
  185  delivered, issued, renewed, or amended on or after January 1,
  186  2026.
  187         Section 4. Section 627.65746, Florida Statutes, is created
  188  to read:
  189         627.65746 Coverage for diabetes drugs and devices.—
  190         (1)As used in this section, the term:
  191         (a)“Cost-sharing requirement” means an insured’s
  192  deductible, coinsurance, copayment, or similar out-of-pocket
  193  expense.
  194         (b)“Diabetes device” means a device, including, but not
  195  limited to, a blood glucose test strip, a glucometer, a
  196  continuous glucometer, a lancet, a lancing device, or an insulin
  197  syringe, used to cure, diagnose, mitigate, prevent, or treat
  198  diabetes or low blood sugar.
  199         (c)“Diabetic ketoacidosis device” means a device that is
  200  used to screen for or prevent diabetic ketoacidosis.
  201         (d)“Glucagon drug” means a drug that contains glucagon
  202  which is prescribed for self-administration on an outpatient
  203  basis and approved by the federal Food and Drug Administration
  204  to treat low blood sugar.
  205         (e)“Insulin drug” means a drug, including, but not limited
  206  to, an insulin pen, which contains insulin and is prescribed for
  207  self-administration on an outpatient basis and approved by the
  208  federal Food and Drug Administration to treat diabetes.
  209         (f)“Laboratory and diagnostic testing and screening for
  210  diabetes” includes hemoglobin A1C testing and retinopathy
  211  screening.
  212         (g)“Noninsulin drug” means a drug, including, but not
  213  limited to, a glucagon drug, glucose tablet, or glucose gel,
  214  that does not contain insulin and is approved by the federal
  215  Food and Drug Administration to treat diabetes.
  216         (2)A health insurance policy must provide coverage for
  217  laboratory and diagnostic testing and screening for diabetes if
  218  such testing and screening is covered under the policy, subject
  219  to the same policy provisions that apply to other covered
  220  services.
  221         (3)A health insurance policy may not impose a cost-sharing
  222  requirement that exceeds $35 for a 30-day supply of an insulin,
  223  noninsulin, or glucagon drug or $100 for a 30-day supply of all
  224  medically necessary covered diabetes and diabetic ketoacidosis
  225  devices.
  226         (4)This section applies to all health insurance policies
  227  delivered, issued, renewed, or amended on or after January 1,
  228  2026.
  229         Section 5. Section 641.31078, Florida Statutes, is created
  230  to read:
  231         641.31078 Coverage for diabetes drugs and devices.—
  232         (1)As used in this section, the term:
  233         (a)“Cost-sharing requirement” means an insured’s
  234  deductible, coinsurance, copayment, or similar out-of-pocket
  235  expense.
  236         (b)“Diabetes device” means a device, including, but not
  237  limited to, a blood glucose test strip, a glucometer, a
  238  continuous glucometer, a lancet, a lancing device, or an insulin
  239  syringe, used to cure, diagnose, mitigate, prevent, or treat
  240  diabetes or low blood sugar.
  241         (c)“Diabetic ketoacidosis device” means a device that is
  242  used to screen for or prevent diabetic ketoacidosis.
  243         (d)“Glucagon drug” means a drug that contains glucagon
  244  which is prescribed for self-administration on an outpatient
  245  basis and approved by the federal Food and Drug Administration
  246  to treat low blood sugar.
  247         (e)“Insulin drug” means a drug, including, but not limited
  248  to, an insulin pen, which contains insulin and is prescribed for
  249  self-administration on an outpatient basis and approved by the
  250  federal Food and Drug Administration to treat diabetes.
  251         (f)“Laboratory and diagnostic testing and screening for
  252  diabetes” includes hemoglobin A1C testing and retinopathy
  253  screening.
  254         (g)“Noninsulin drug” means a drug, including, but not
  255  limited to, a glucagon drug, glucose tablet, or glucose gel,
  256  that does not contain insulin and is approved by the federal
  257  Food and Drug Administration to treat diabetes.
  258         (2)A health maintenance contract must provide coverage for
  259  laboratory and diagnostic testing and screening for diabetes if
  260  such testing and screening is covered under the policy, subject
  261  to the same policy provisions that apply to other covered
  262  services.
  263         (3)A health maintenance contract may not impose a cost
  264  sharing requirement that exceeds $35 for a 30-day supply of an
  265  insulin, noninsulin, or glucagon drug or $100 for a 30-day
  266  supply of all medically necessary covered diabetes and diabetic
  267  ketoacidosis devices.
  268         (4)This section applies to all health maintenance contract
  269  delivered, issued, renewed, or amended on or after January 1,
  270  2026.
  271         Section 6. Present subsection (16) of section 893.055,
  272  Florida Statutes, is redesignated as subsection (17), a new
  273  subsection (16) is added to that section, and paragraph (c) of
  274  subsection (4) of that section is amended, to read:
  275         893.055 Prescription drug monitoring program.—
  276         (4) The following persons must be provided direct access to
  277  information in the system:
  278         (c) The program manager or designated program and support
  279  staff to administer the system.
  280         1. In order to calculate performance measures pursuant to
  281  subsection (14), the program manager or program and support
  282  staff members who have been directed by the program manager to
  283  calculate performance measures may have direct access to
  284  information that contains no identifying information of any
  285  patient, physician, health care practitioner, prescriber, or
  286  dispenser.
  287         2. The program manager or designated program and support
  288  staff must provide the department, upon request, data that does
  289  not contain patient, physician, health care practitioner,
  290  prescriber, or dispenser identifying information for public
  291  health care and safety initiatives purposes.
  292         3. The program manager, upon determining a pattern
  293  consistent with the department’s rules established under
  294  subsection (17) (16), may provide relevant information to the
  295  prescriber and dispenser.
  296         4. The program manager, upon determining a pattern
  297  consistent with the rules established under subsection (17) (16)
  298  and having cause to believe a violation of s. 893.13(7)(a)8.,
  299  (8)(a), or (8)(b) has occurred, may provide relevant information
  300  to the applicable law enforcement agency.
  301  
  302  The program manager and designated program and support staff
  303  must complete a level II background screening.
  304         (16) In the manner prescribed for controlled substances
  305  provided under this section, each dispenser shall report to the
  306  system all insulin drugs, glucagon drugs, diabetes devices, and
  307  diabetic ketoacidosis devices dispensed. The terms insulin
  308  drug,” glucagon drug,” diabetes device,” and diabetic
  309  ketoacidosis device have the same meaning as in s.
  310  465.0275(3)(a).
  311         Section 7. This act shall take effect July 1, 2025.