Florida Senate - 2022 SB 564
By Senator Harrell
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.
34 Be It Enacted by the Legislature of the State of Florida:
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
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.
(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
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
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
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.
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
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
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.
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.