HB 633 2022
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A bill to be entitled 1
An act relating to insurance coverages for drugs and 2
medical procedures and treatments; 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 have 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 approved by the Financial Services Commission; 24
authorizing the commission to adopt certain rules; 25
HB 633 2022
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specifying requirements for, and restrictions on , 26
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 39
cancer.— 40
(1) DEFINITIONS.—As used in this section, the term: 41
(a) "Associated condition" means a symptom or side effect 42
that: 43
1. Is associated with a particular cancer at a particular 44
stage or with the treatment of that cancer; and 45
2. In the judgment of a health care provider, will further 46
jeopardize the health of a patient if left untreated. As used in 47
this subparagraph, the term "health care provider" means a 48
physician licensed under chapter 458, chapter 459, or chapter 49
461; a physician assistant licensed under chapter 458 or chapter 50
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459; an advanced practice registered nurse licensed under 51
chapter 464; or a dentist licensed under chapter 466. 52
(b) "Medical literature" means scientific studies 53
published in a United States peer -reviewed national professional 54
journal. 55
(c)(b) "Standard reference compendium" means authoritative 56
compendia identified by the Secretary of the United States 57
Department of Health and Human Services and recognized by the 58
federal Centers for Medicare and Medic aid Services. 59
(2) COVERAGE FOR TREATMENT OF CANCER. — 60
(a) An insurer or a health maintenance organization may 61
not exclude coverage in any individual or group health insurance 62
policy or health maintenance contract issued, amended, 63
delivered, or renewed i n this state which covers the treatment 64
of cancer for any drug prescribed for the treatment of cancer on 65
the ground that the drug is not approved by the United States 66
Food and Drug Administration for a particular indication, if 67
that drug is recognized for treatment of that indication in a 68
standard reference compendium or recommended in the medical 69
literature. 70
(b) Coverage for a drug required by this section also 71
includes the medically necessary services associated with the 72
administration of the drug. 73
(3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER 74
AND ASSOCIATED CONDITIONS. — 75
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(a) An insurer or a health maintenance organization may 76
not require in any individual or group health insurance policy 77
or health maintenance contract issued, amended, deliv ered, or 78
renewed in this state which covers the treatment of stage 4 79
metastatic cancer and its associated conditions that, before a 80
drug prescribed for the treatment is covered, the insured or 81
subscriber fail or have previously failed to respond 82
successfully to a different drug. 83
(b) Paragraph (a) applies to a drug that is recognized for 84
the treatment of stage 4 metastatic cancer or its associated 85
conditions, as applicable, in a standard reference compendium or 86
that is recommended in the medical literature. The insurer or 87
health maintenance organization may not exclude coverage for 88
such drug on the ground that the drug is not approved by the 89
United States Food and Drug Administration for stage 4 90
metastatic cancer or its associated conditions, as a pplicable. 91
(4) COVERAGE FOR SERVICES ASSOCIATED WITH DRUG 92
ADMINISTRATION.—Coverage for a drug required by this section 93
also includes the medically necessary services associated with 94
the administration of the drug. 95
(5) PROHIBITION ON MANDATORY HOME INFU SION.—An insurer or 96
a health maintenance organization may not require that a cancer 97
medication be administered using home infusion, and may not 98
require that such medication be sent directly to a third party 99
or to the patient for home infusion, unless the p atient's 100
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treating oncologist determines that home infusion of the cancer 101
medication will not jeopardize the health of the patient. 102
(6) APPLICABILITY AND SCOPE. —This section may not be 103
construed to: 104
(a) Alter any other law with regard to provisions limi ting 105
coverage for drugs that are not approved by the United States 106
Food and Drug Administration , except for drugs for the treatment 107
of stage 4 metastatic cancer or its associated conditions . 108
(b) Require coverage for any drug , except for a drug for 109
the treatment of stage 4 metastatic cancer or its associated 110
conditions, if the United States Food and Drug Administration 111
has determined that the use of the drug is contraindicated. 112
(c) Require coverage for a drug that is not otherwise 113
approved for any indica tion by the United States Food and Drug 114
Administration, except for a drug for the treatment of stage 4 115
metastatic cancer or its associated conditions . 116
(d) Affect the determination as to whether particular 117
levels, dosages, or usage of a medication associa ted with bone 118
marrow transplant procedures are covered under an individual or 119
group health insurance policy or health maintenance organization 120
contract. 121
(e) Apply to specified disease or supplemental policies. 122
(f)(4) Nothing in this section is intended , Expressly or 123
by implication, to create, impair, alter, limit, modify, 124
enlarge, abrogate, prohibit, or withdraw any authority to 125
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provide reimbursement for drugs used in the treatment of any 126
other disease or condition. 127
Section 2. Section 627.42392, Flo rida Statutes, is amended 128
to read: 129
(1) As used in this section, the term : 130
(a) "Health insurer" means an authorized insurer offering 131
an individual or group health insurance policy that provides 132
major medical or similar comprehensive coverage health insurance 133
as defined in s. 624.603 , a managed care plan as defined in s. 134
409.962(10), or a health maintenance organization as defined in 135
s. 641.19(12). 136
(b) "Urgent care situation" means an injury or a condition 137
of an insured which, if medical care and treatm ent are not 138
provided earlier than the time the medical profession generally 139
considers reasonable for a nonurgent situation, in the opinion 140
of the insured's treating physician, physician assistant, or 141
advanced practice registered nurse, would: 142
1. Seriously jeopardize the insured's life, health, or 143
ability to regain maximum function; or 144
2. Subject the insured to severe pain that cannot be 145
adequately managed. 146
(2) Notwithstanding any other provision of law, effective 147
January 1, 2023 January 1, 2017, or 6 six (6) months after the 148
effective date of the rule adopting the prior authorization 149
form, whichever is later, a health insurer, or a pharmacy 150
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benefits manager on behalf of the health insurer, which does not 151
provide an electronic prior authorization proces s for use by its 152
contracted providers, shall only use only the prior 153
authorization form that has been approved by the Financial 154
Services Commission for granting a prior authorization for a 155
medical procedure, course of treatment, or prescription drug 156
benefit. Such form may not exceed two pages in length, excluding 157
any instructions or guiding documentation, and must include all 158
clinical documentation necessary for the health insurer to make 159
a decision. At a minimum, the form must include all of the 160
following: 161
(a)(1) Sufficient patient information to identify the 162
member, including his or her date of birth, full name, and 163
Health Plan ID number .; 164
(b)(2) The provider's provider name, address, and phone 165
number.; 166
(c)(3) The medical procedure, course of treatment, or 167
prescription drug benefit being requested, including the medical 168
reason therefor, and all services tried and failed .; 169
(d)(4) Any required laboratory documentation . required; 170
and 171
(e)(5) An attestation that all information provided is 172
true and accurate. 173
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The form, whether in electronic or paper format, must require 175
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only that information necessary for the determination of the 176
medical necessity of, or coverage for, the requested medical 177
procedure, course of t reatment, or prescription drug benefit. 178
The commission may adopt rules prescribing such necessary 179
information. 180
(3) The Financial Services Commission in consultation with 181
the Agency for Health Care Administration shall adopt by rule 182
guidelines for all pri or authorization forms which ensure the 183
general uniformity of such forms. 184
(4) Electronic prior authorization approvals do not 185
preclude benefit verification or medical review by the insurer 186
under either the medical or pharmacy benefits. 187
Prior authorization.— 188
(5) A health insurer, or a pharmacy benefits manager on 189
behalf of the health insurer, shall, upon request, provide the 190
following information in electronic or paper format and publish 191
it on a publicly accessible website: 192
(a) Detailed descriptions, i n clear, easily understandable 193
language, of the requirements for, and restrictions on, 194
obtaining prior authorization for coverage of a medical 195
procedure, course of treatment, or prescription drug. Clinical 196
criteria must be described in language that a heal th care 197
provider can easily understand. 198
(b) Prior authorization forms. 199
(6) A health insurer, or a pharmacy benefits manager on 200
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behalf of the health insurer, may not implement any new 201
requirements or restrictions or make changes to existing 202
requirements or restrictions on obtaining prior authorization 203
unless: 204
(a) The changes have been available on a publicly 205
accessible website for at least 60 days before they are 206
implemented; and 207
(b) Insureds and health care providers affected by the new 208
requirements and restrictions or changes to the requirements and 209
restrictions are provided with a written notice of the changes 210
at least 60 days before they are implemented. Such notice may be 211
delivered electronically or by other means as agreed to by the 212
insured or the health care provider. 213
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This subsection does not apply to the expansion of health care 215
services coverage. 216
(7) A health insurer, or a pharmacy benefits manager on 217
behalf of the health insurer, shall authorize or deny a prior 218
authorization request and no tify the patient and the patient's 219
treating health care provider of the decision within: 220
(a) Seventy-two hours after receiving a completed prior 221
authorization form for nonurgent care situations. 222
(b) Twenty-four hours after receiving a completed prior 223
authorization form for urgent care situations. 224
Section 3. This act shall take effect January 1, 2023. 225