F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
HB 633 2022
1 A bill to be entitled
2 An act relating to insurance coverages for drugs and
3 medical procedures and treatments; amending s.
4 627.4239, F.S.; defining the terms "associated
5 condition" and "health care provider"; prohibiting
6 health maintenance organizations from excluding
7 coverage for certain cancer treatment drugs;
8 prohibiting health insurers and health maintenance
9 organizations from requiring, before providing
10 prescription drug coverage for the treatment of stage
11 4 metastatic cancer and associated conditions, that
12 treatment have failed with a different drug; providing
13 applicability; prohibiting insurers and health
14 maintenance organizations from excluding coverage for
15 certain drugs on certain grounds; prohibiting insurers
16 and health maintenance organizations from requiring
17 home infusion for certain cancer treatment drugs or
18 that certain cancer treatment drugs be sent to certain
19 entities for home infusion unless a certain condition
20 is met; revising construction; amending s. 627.42392,
21 F.S.; revising the definition of the term "health
22 insurer"; defining the term "urgent care situation";
23 specifying a requirement for the prior authorization
24 form approved by the Financial Services Commission;
25 authorizing the commission to adopt certain rules;
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26 specifying requirements for, and restrictions on,
27 health insurers and pharmacy benefits managers
28 relating to prior authorization information,
29 requirements, restrictions, and changes; providing
30 applicability; specifying timeframes in which prior
31 authorization requests must be authorized or denied
32 and the patient and the patient's provider must be
33 notified; providing an effective date.
34
35 Be It Enacted by the Legislature of the State of Florida:
36
37 Section 1. Section 627.4239, Florida Statutes, is amended
38 to read:
39 627.4239 Coverage for use of drugs in treatment of
40 cancer.—
41 (1) DEFINITIONS.—As used in this section, the term:
42 (a) "Associated condition" means a symptom or side effect
43 that:
44 1. Is associated with a particular cancer at a particular
45 stage or with the treatment of that cancer; and
46 2. In the judgment of a health care provider, will further
47 jeopardize the health of a patient if left untreated. As used in
48 this subparagraph, the term "health care provider" means a
49 physician licensed under chapter 458, chapter 459, or chapter
50 461; a physician assistant licensed under chapter 458 or chapter
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HB 633 2022
51 459; an advanced practice registered nurse licensed under
52 chapter 464; or a dentist licensed under chapter 466.
53 (b) "Medical literature" means scientific studies
54 published in a United States peer-reviewed national professional
55 journal.
56 (c)(b) "Standard reference compendium" means authoritative
57 compendia identified by the Secretary of the United States
58 Department of Health and Human Services and recognized by the
59 federal Centers for Medicare and Medicaid Services.
60 (2) COVERAGE FOR TREATMENT OF CANCER.—
61 (a) An insurer or a health maintenance organization may
62 not exclude coverage in any individual or group health insurance
63 policy or health maintenance contract issued, amended,
64 delivered, or renewed in this state which covers the treatment
65 of cancer for any drug prescribed for the treatment of cancer on
66 the ground that the drug is not approved by the United States
67 Food and Drug Administration for a particular indication, if
68 that drug is recognized for treatment of that indication in a
69 standard reference compendium or recommended in the medical
70 literature.
71 (b) Coverage for a drug required by this section also
72 includes the medically necessary services associated with the
73 administration of the drug.
74 (3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER
75 AND ASSOCIATED CONDITIONS.—
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76 (a) An insurer or a health maintenance organization may
77 not require in any individual or group health insurance policy
78 or health maintenance contract issued, amended, deliv ered, or
79 renewed in this state which covers the treatment of stage 4
80 metastatic cancer and its associated conditions that, before a
81 drug prescribed for the treatment is covered, the insured or
82 subscriber fail or have previously failed to respond
83 successfully to a different drug.
84 (b) Paragraph (a) applies to a drug that is recognized for
85 the treatment of stage 4 metastatic cancer or its associated
86 conditions, as applicable, in a standard reference compendium or
87 that is recommended in the medical literature. The insurer or
88 health maintenance organization may not exclude coverage for
89 such drug on the ground that the drug is not approved by the
90 United States Food and Drug Administration for stage 4
91 metastatic cancer or its associated conditions, as applicable.
92 (4) COVERAGE FOR SERVICES ASSOCIATED WITH DRUG
93 ADMINISTRATION.—Coverage for a drug required by this section
94 also includes the medically necessary services associated with
95 the administration of the drug.
96 (5) PROHIBITION ON MANDATORY HOME INFUSION.—An insurer or
97 a health maintenance organization may not require that a cancer
98 medication be administered using home infusion, and may not
99 require that such medication be sent directly to a third party
100 or to the patient for home infusion, unless the patient's
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101 treating oncologist determines that home infusion of the cancer
102 medication will not jeopardize the health of the patient.
103 (6) APPLICABILITY AND SCOPE.—This section may not be
104 construed to:
105 (a) Alter any other law with regard to provisions limi ting
106 coverage for drugs that are not approved by the United States
107 Food and Drug Administration, except for drugs for the treatment
108 of stage 4 metastatic cancer or its associated conditions.
109 (b) Require coverage for any drug, except for a drug for
110 the treatment of stage 4 metastatic cancer or its associated
111 conditions, if the United States Food and Drug Administration
112 has determined that the use of the drug is contraindicated.
113 (c) Require coverage for a drug that is not otherwise
114 approved for any indication by the United States Food and Drug
115 Administration, except for a drug for the treatment of stage 4
116 metastatic cancer or its associated conditions.
117 (d) Affect the determination as to whether particular
118 levels, dosages, or usage of a medication associated with bone
119 marrow transplant procedures are covered under an individual or
120 group health insurance policy or health maintenance organization
121 contract.
122 (e) Apply to specified disease or supplemental policies.
123 (f)(4) Nothing in this section is intended, Expressly or
124 by implication, to create, impair, alter, limit, modify,
125 enlarge, abrogate, prohibit, or withdraw any authority to
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126 provide reimbursement for drugs used in the treatment of any
127 other disease or condition.
128 Section 2. Section 627.42392, Florida Statutes, is amended
129 to read:
130 (1) As used in this section, the term:
131 (a) "Health insurer" means an authorized insurer offering
132 an individual or group health insurance policy that provides
133 major medical or similar comprehensive coverage health insurance
134 as defined in s. 624.603, a managed care plan as defined in s.
135 409.962(10), or a health maintenance organization as defined in
136 s. 641.19(12).
137 (b) "Urgent care situation" means an injury or a condition
138 of an insured which, if medical care and treatment are not
139 provided earlier than the time the medical profession generally
140 considers reasonable for a nonurgent situation, in the opinion
141 of the insured's treating physician, physician assistant, or
142 advanced practice registered nurse, would:
143 1. Seriously jeopardize the insured's life, health, or
144 ability to regain maximum function; or
145 2. Subject the insured to severe pain that cannot be
146 adequately managed.
147 (2) Notwithstanding any other provision of law, effective
148 January 1, 2023 January 1, 2017, or 6 six (6) months after the
149 effective date of the rule adopting the prior authorization
150 form, whichever is later, a health insurer, or a pharmacy
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151 benefits manager on behalf of the health insurer, which does not
152 provide an electronic prior authorization process for use by its
153 contracted providers, shall only use only the prior
154 authorization form that has been approved by the Financial
155 Services Commission for granting a prior authorization for a
156 medical procedure, course of treatment, or prescription drug
157 benefit. Such form may not exceed two pages in length, excluding
158 any instructions or guiding documentation, and must include all
159 clinical documentation necessary for the health insurer to make
160 a decision. At a minimum, the form must include all of the
161 following:
162 (a)(1) Sufficient patient information to identify the
163 member, including his or her date of birth, full name, and
164 Health Plan ID number.;
165 (b)(2) The provider's provider name, address, and phone
166 number.;
167 (c)(3) The medical procedure, course of treatment, or
168 prescription drug benefit being requested, including the medical
169 reason therefor, and all services tried and failed.;
170 (d)(4) Any required laboratory documentation. required;
171 and
172 (e)(5) An attestation that all information provided is
173 true and accurate.
174
175 The form, whether in electronic or paper format, must require
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176 only that information necessary for the determination of the
177 medical necessity of, or coverage for, the requested medical
178 procedure, course of treatment, or prescription drug benefit.
179 The commission may adopt rules prescribing such necessary
180 information.
181 (3) The Financial Services Commission in consultation with
182 the Agency for Health Care Administration shall adopt by rule
183 guidelines for all prior authorization forms which ensure the
184 general uniformity of such forms.
185 (4) Electronic prior authorization approvals do not
186 preclude benefit verification or medical review by the insurer
187 under either the medical or pharmacy benefits.
188 Prior authorization.—
189 (5) A health insurer, or a pharmacy benefits manager on
190 behalf of the health insurer, shall, upon request, provide the
191 following information in electronic or paper format and publish
192 it on a publicly accessible website:
193 (a) Detailed descriptions, in clear, easily understandable
194 language, of the requirements for, and restrictions on,
195 obtaining prior authorization for coverage of a medical
196 procedure, course of treatment, or prescription drug. Clinical
197 criteria must be described in language that a health care
198 provider can easily understand.
199 (b) Prior authorization forms.
200 (6) A health insurer, or a pharmacy benefits manager on
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201 behalf of the health insurer, may not implement any new
202 requirements or restrictions or make changes to existing
203 requirements or restrictions on obtaining prior authorization
204 unless:
205 (a) The changes have been available on a publicly
206 accessible website for at least 60 days before they are
207 implemented; and
208 (b) Insureds and health care providers affected by the new
209 requirements and restrictions or changes to the requirements and
210 restrictions are provided with a written notice of the changes
211 at least 60 days before they are implemented. Such notice may be
212 delivered electronically or by other means as agreed to by the
213 insured or the health care provider.
214
215 This subsection does not apply to the expansion of health care
216 services coverage.
217 (7) A health insurer, or a pharmacy benefits manager on
218 behalf of the health insurer, shall authorize or deny a prior
219 authorization request and notify the pati