Florida Senate - 2022                                     SB 564
       
       
        
       By Senator Harrell
       
       
       
       
       
       25-00649-22                                            2022564__
    1                        A bill to be entitled                      
    2         An act relating to health insurance; amending s.
    3         627.4239, F.S.; defining the terms “associated
    4         condition” and “health care provider”; prohibiting
    5         health maintenance organizations from excluding
    6         coverage for certain cancer treatment drugs;
    7         prohibiting health insurers and health maintenance
    8         organizations from requiring, before providing
    9         prescription drug coverage for the treatment of stage
   10         4 metastatic cancer and associated conditions, that
   11         treatment has failed with a different drug; providing
   12         applicability; prohibiting insurers and health
   13         maintenance organizations from excluding coverage for
   14         certain drugs on certain grounds; prohibiting insurers
   15         and health maintenance organizations from requiring
   16         home infusion for certain cancer treatment drugs or
   17         that certain cancer treatment drugs be sent to certain
   18         entities for home infusion unless a certain condition
   19         is met; revising construction; amending s. 627.42392,
   20         F.S.; revising the definition of the term “health
   21         insurer”; defining the term “urgent care situation”;
   22         specifying a requirement for the prior authorization
   23         form adopted by the Financial Services Commission by
   24         rule; authorizing the commission to adopt certain
   25         rules; specifying requirements for, and restrictions
   26         on, health insurers and pharmacy benefits managers
   27         relating to prior authorization information,
   28         requirements, restrictions, and changes; providing
   29         applicability; specifying timeframes in which prior
   30         authorization requests must be authorized or denied
   31         and the patient and the patient’s provider must be
   32         notified; providing an effective date.
   33          
   34  Be It Enacted by the Legislature of the State of Florida:
   35  
   36         Section 1. Section 627.4239, Florida Statutes, is amended
   37  to read:
   38         627.4239 Coverage for use of drugs in treatment of cancer.—
   39         (1) DEFINITIONS.—As used in this section, the term:
   40         (a) “Associated condition” means a symptom or side effect
   41  that:
   42         1.Is associated with a particular cancer at a particular
   43  stage or with the treatment of that cancer; and
   44         2.In the judgment of a health care provider, will further
   45  jeopardize the health of a patient if left untreated. As used in
   46  this subparagraph, the term “health care provider” means a
   47  physician licensed under chapter 458, chapter 459, or chapter
   48  461; a physician assistant licensed under chapter 458 or chapter
   49  459; an advanced practice registered nurse licensed under
   50  chapter 464; or a dentist licensed under chapter 466.
   51         (b) “Medical literature” means scientific studies published
   52  in a United States peer-reviewed national professional journal.
   53         (c)(b) “Standard reference compendium” means authoritative
   54  compendia identified by the Secretary of the United States
   55  Department of Health and Human Services and recognized by the
   56  federal Centers for Medicare and Medicaid Services.
   57         (2) COVERAGE FOR TREATMENT OF CANCER.—
   58         (a) An insurer or a health maintenance organization may not
   59  exclude coverage in any individual or group health insurance
   60  policy or health maintenance contract issued, amended,
   61  delivered, or renewed in this state which covers the treatment
   62  of cancer for any drug prescribed for the treatment of cancer on
   63  the ground that the drug is not approved by the United States
   64  Food and Drug Administration for a particular indication, if
   65  that drug is recognized for treatment of that indication in a
   66  standard reference compendium or recommended in the medical
   67  literature.
   68         (b)Coverage for a drug required by this section also
   69  includes the medically necessary services associated with the
   70  administration of the drug.
   71         (3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER AND
   72  ASSOCIATED CONDITIONS.—
   73         (a)An insurer or a health maintenance organization may not
   74  require in any individual or group health insurance policy or
   75  health maintenance contract issued, amended, delivered, or
   76  renewed in this state which covers the treatment of stage 4
   77  metastatic cancer and its associated conditions that, before a
   78  drug prescribed for the treatment is covered, the insured or
   79  subscriber fail or have previously failed to respond
   80  successfully to a different drug.
   81         (b)Paragraph (a) applies to a drug that is recognized for
   82  the treatment of stage 4 metastatic cancer or its associated
   83  conditions, as applicable, in a standard reference compendium or
   84  that is recommended in the medical literature. The insurer or
   85  health maintenance organization may not exclude coverage for
   86  such drug on the ground that the drug is not approved by the
   87  United States Food and Drug Administration for stage 4
   88  metastatic cancer or its associated conditions, as applicable.
   89         (4)COVERAGE FOR SERVICES ASSOCIATED WITH DRUG
   90  ADMINISTRATION.—Coverage for a drug required by this section
   91  also includes the medically necessary services associated with
   92  the administration of the drug.
   93         (5)PROHIBITION ON MANDATORY HOME INFUSION.—An insurer or a
   94  health maintenance organization may not require that a cancer
   95  medication be administered using home infusion, and may not
   96  require that such medication be sent directly to a third party
   97  or to the patient for home infusion, unless the patient’s
   98  treating oncologist determines that home infusion of the cancer
   99  medication will not jeopardize the health of the patient.
  100         (6) APPLICABILITY AND SCOPE.—This section may not be
  101  construed to:
  102         (a) Alter any other law with regard to provisions limiting
  103  coverage for drugs that are not approved by the United States
  104  Food and Drug Administration, except for drugs for the treatment
  105  of stage 4 metastatic cancer or its associated conditions.
  106         (b) Require coverage for any drug, except for a drug for
  107  the treatment of stage 4 metastatic cancer or its associated
  108  conditions, if the United States Food and Drug Administration
  109  has determined that the use of the drug is contraindicated.
  110         (c) Require coverage for a drug that is not otherwise
  111  approved for any indication by the United States Food and Drug
  112  Administration, except for a drug for the treatment of stage 4
  113  metastatic cancer or its associated conditions.
  114         (d) Affect the determination as to whether particular
  115  levels, dosages, or usage of a medication associated with bone
  116  marrow transplant procedures are covered under an individual or
  117  group health insurance policy or health maintenance organization
  118  contract.
  119         (e) Apply to specified disease or supplemental policies.
  120         (f)(4)Nothing in this section is intended, Expressly or by
  121  implication, to create, impair, alter, limit, modify, enlarge,
  122  abrogate, prohibit, or withdraw any authority to provide
  123  reimbursement for drugs used in the treatment of any other
  124  disease or condition.
  125         Section 2. Section 627.42392, Florida Statutes, is amended
  126  to read:
  127         627.42392 Prior authorization.—
  128         (1) As used in this section, the term:
  129         (a) “Health insurer” means an authorized insurer offering
  130  an individual or group health insurance policy that provides
  131  major medical or similar comprehensive coverage health insurance
  132  as defined in s. 624.603, a managed care plan as defined in s.
  133  409.962(10), or a health maintenance organization as defined in
  134  s. 641.19(12).
  135         (b)“Urgent care situation” means an injury or a condition
  136  of an insured which, if medical care and treatment are not
  137  provided earlier than the time the medical profession generally
  138  considers reasonable for a nonurgent situation, in the opinion
  139  of the insured’s treating physician, physician assistant, or
  140  advanced practice registered nurse, would:
  141         1. Seriously jeopardize the insured’s life, health, or
  142  ability to regain maximum function; or
  143         2. Subject the insured to severe pain that cannot be
  144  adequately managed.
  145         (2) Notwithstanding any other provision of law, effective
  146  January 1, 2017, or six (6) months after the effective date of
  147  the rule adopting the prior authorization form, whichever is
  148  later, a health insurer, or a pharmacy benefits manager on
  149  behalf of the health insurer, which does not provide an
  150  electronic prior authorization process for use by its contracted
  151  providers, shall only use only the prior authorization form that
  152  has been approved by the Financial Services Commission for
  153  granting a prior authorization for a medical procedure, course
  154  of treatment, or prescription drug benefit. Such form may not
  155  exceed two pages in length, excluding any instructions or
  156  guiding documentation, and must include all clinical
  157  documentation necessary for the health insurer to make a
  158  decision. At a minimum, the form must include all of the
  159  following:
  160         (a)(1) Sufficient patient information to identify the
  161  member, including his or her date of birth, full name, and
  162  Health Plan ID number.;
  163         (b)(2)The provider’s provider name, address, and phone
  164  number.;
  165         (c)(3) The medical procedure, course of treatment, or
  166  prescription drug benefit being requested, including the medical
  167  reason therefor, and all services tried and failed.;
  168         (d)(4) Any required laboratory documentation. required; and
  169         (e)(5) An attestation that all information provided is true
  170  and accurate.
  171  
  172  The form, whether in electronic or paper format, must require
  173  only that information necessary for the determination of the
  174  medical necessity of, or coverage for, the requested medical
  175  procedure, course of treatment, or prescription drug benefit.
  176  The commission may adopt rules prescribing such necessary
  177  information.
  178         (3) The Financial Services Commission, in consultation with
  179  the Agency for Health Care Administration, shall adopt by rule
  180  guidelines for all prior authorization forms which ensure the
  181  general uniformity of such forms.
  182         (4) Electronic prior authorization approvals do not
  183  preclude benefit verification or medical review by the insurer
  184  under either the medical or pharmacy benefits.
  185         (5)A health insurer, or a pharmacy benefits manager on
  186  behalf of the health insurer, shall, upon request, provide the
  187  following information in writing or in an electronic format and
  188  publish it on a publicly accessible website:
  189         (a)Detailed descriptions, in clear, easily understandable
  190  language, of the requirements for, and restrictions on,
  191  obtaining prior authorization for coverage of a medical
  192  procedure, course of treatment, or prescription drug. Clinical
  193  criteria must be described in language that a health care
  194  provider can easily understand.
  195         (b)Prior authorization forms.
  196         (6)A health insurer, or a pharmacy benefits manager on
  197  behalf of the health insurer, may not implement any new
  198  requirements or restrictions or make changes to existing
  199  requirements or restrictions on obtaining prior authorization
  200  unless:
  201         (a)The changes have been available on a publicly
  202  accessible website for at least 60 days before they are
  203  implemented; and
  204         (b)Policyholders and health care providers affected by the
  205  new requirements and restrictions or changes to the requirements
  206  and restrictions are provided with a written notice of the
  207  changes at least 60 days before they are implemented. Such
  208  notice may be delivered electronically or by other means as
  209  agreed to by the insured or the health care provider.
  210  
  211  This subsection does not apply to the expansion of health care
  212  services coverage.
  213         (7)A health insurer, or a pharmacy benefits manager on
  214  behalf of the health insurer, shall authorize or deny a prior
  215  authorization request and notify the patient and the patient’s
  216  treating health care provider of the decision within:
  217         (a)Seventy-two hours after receiving a completed prior
  218  authorization form, for nonurgent care situations.
  219         (b)Twenty-four hours after receiving a completed prior
  220  authorization form, for urgent care situations.
  221         Section 3. This act shall take effect January 1, 2023.