HB 459 2022
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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
A bill to be entitled 1
An act relating to step -therapy protocols; amending s. 2
627.42393, F.S.; revising the circumstances under 3
which step-therapy protocols may not be required; 4
defining terms; requiring health insurers to publish 5
on their websites and provide to their insureds 6
specified information; providing requirements for 7
procedures for requests and appeals of denials of 8
protocol exemptions; providing requirements for 9
authorizations and denials of protocol exemption 10
requests; authorizing health insurers to request 11
specified documentation under certain circumstances; 12
amending s. 641.31, F.S.; revising the circumstances 13
under which step-therapy protocols may not be 14
required; defining terms; requiring health maintenance 15
organizations to publish on their websites and provide 16
to their subscribers specified information; providing 17
requirements for procedures for requests and appeals 18
of denials of protocol exemptions; providing 19
requirements for authorizations and denials of 20
protocol exemption requests; authorizing health 21
maintenance organizations to request specified 22
documentation under certain circumstances; providing 23
an effective date. 24
25
HB 459 2022
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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
Be It Enacted by the Legislature of the Stat e of Florida: 26
27
Section 1. Section 627.42393, Florida Statutes, is amended 28
to read: 29
627.42393 Step-therapy protocol.— 30
(1)(2) As used in this section, the term : 31
(a) "Health coverage plan" means any of the following 32
which is currently or was previou sly providing major medical or 33
similar comprehensive coverage or benefits to the insured: 34
1.(a) A health insurer or health maintenance organization. 35
2.(b) A plan established or maintained by an individual 36
employer as provided by the Employee Retirement Income Security 37
Act of 1974, Pub. L. No. 93 -406. 38
3.(c) A multiple-employer welfare arrangement as defined 39
in s. 624.437. 40
4.(d) A governmental entity providing a plan of self -41
insurance. 42
(b) "Protocol exemption" means a determination by a health 43
insurer to authorize the use of another prescription drug, 44
medical procedure, or course of treatment prescribed or 45
recommended by the treating health care provider for the 46
insured's condition rather than the one specified by the health 47
insurer's step-therapy protocol. 48
(c) "Step-therapy protocol" means a written protocol that 49
specifies the order in which certain prescription drugs, medical 50
HB 459 2022
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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
procedures, or courses of treatment must be used to treat an 51
insured's condition. 52
(2)(1) In addition to the protocol exem ptions granted 53
under subsection (3), a health insurer issuing a major medical 54
individual or group policy may not require a step -therapy 55
protocol under the policy for a covered prescription drug 56
requested by an insured if: 57
(a) The insured has previously b een approved to receive 58
the prescription drug through the completion of a step -therapy 59
protocol required by a separate health coverage plan; and 60
(b) The insured provides documentation originating from 61
the health coverage plan that approved the prescription drug as 62
described in paragraph (a) indicating that the health coverage 63
plan paid for the drug on the insured's behalf during the 90 64
days immediately before the request. 65
(3)(a) A health insurer shall publish on its website and 66
provide to an insured in writing a procedure for the insured and 67
his or her health care provider to request a protocol exemption 68
or an appeal of the health insurer's denial of a protocol 69
exemption request. The procedure must include, at a minimum: 70
1. The manner in whic h the insured or health care provider 71
may request a protocol exemption, including a form to request 72
the protocol exemption. 73
2. The manner and timeframe in which the health insurer 74
authorizes or denies a protocol exemption request, which must 75
HB 459 2022
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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
occur within a reasonable time. 76
3. The manner and timeframe in which the insured or health 77
care provider may appeal the health insurer's denial of a 78
protocol exemption request. 79
(b) An authorization of a protocol exemption request must 80
specify the approved prescrip tion drug, medical procedure, or 81
course of treatment. A denial of a protocol exemption request 82
must include a written explanation of the reason for the denial, 83
the clinical rationale that supports the denial, and the 84
procedure for appealing the health insu rer's denial. 85
(c) A health insurer may request relevant medical records 86
in support of a protocol exemption request. 87
(4)(3) This section does not require a health insurer to 88
add a drug to its prescription drug formulary or to cover a 89
prescription drug that the insurer does not otherwise cover. 90
Section 2. Subsection (46) of section 641.31, Florida 91
Statutes, is amended to read: 92
641.31 Health maintenance contracts. — 93
(46)(a)(b) As used in this subsection, the term : 94
1. "Health coverage plan" means a ny of the following which 95
previously provided or is currently providing major medical or 96
similar comprehensive coverage or benefits to the subscriber: 97
a.1. A health insurer or health maintenance organization .; 98
b.2. A plan established or maintained by a n individual 99
employer as provided by the Employee Retirement Income Security 100
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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
Act of 1974, Pub. L. No. 93 -406.; 101
c.3. A multiple-employer welfare arrangement as defined in 102
s. 624.437.; or 103
d.4. A governmental entity providing a plan of self -104
insurance. 105
2. "Protocol exemption" means a determination by a health 106
maintenance organization to authorize the use of another 107
prescription drug, medical procedure, or course of treatment 108
prescribed or recommended by the treating health care provider 109
for the subscriber's condition rather than the one specified by 110
the health maintenance organization's step -therapy protocol. 111
3. "Step-therapy protocol" means a written protocol that 112
specifies the order in which certain prescription drugs, medical 113
procedures, or courses of treatment must be used to treat a 114
subscriber's condition. 115
(b)(a) In addition to the protocol exemptions granted 116
under paragraph (c), a health maintenance organization issuing 117
major medical coverage through an individual or group contract 118
may not require a step-therapy protocol under the contract for a 119
covered prescription drug requested by a subscriber if: 120
1. The subscriber has previously been approved to receive 121
the prescription drug through the completion of a step -therapy 122
protocol required by a sepa rate health coverage plan; and 123
2. The subscriber provides documentation originating from 124
the health coverage plan that approved the prescription drug as 125
HB 459 2022
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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
described in subparagraph 1. indicating that the health coverage 126
plan paid for the drug on the subscr iber's behalf during the 90 127
days immediately before the request. 128
(c)1. A health maintenance organization shall publish on 129
its website and provide to a subscriber in writing a procedure 130
for the subscriber and his or her health care provider to 131
request a protocol exemption or an appeal of the health 132
maintenance organization's denial of a protocol exemption 133
request. The procedure must include, at a minimum: 134
a. The manner in which the subscriber or health care 135
provider may request a protocol exemption, incl uding a form to 136
request the protocol exemption. 137
b. The manner and timeframe in which the health 138
maintenance organization authorizes or denies a protocol 139
exemption request, which must occur within a reasonable time. 140
c. The manner and timeframe in which the subscriber or 141
health care provider may appeal the health maintenance 142
organization's denial of a protocol exemption request . 143
2. An authorization of a protocol exemption request must 144
specify the approved prescription drug, medical procedure, or 145
course of treatment. A denial of a protocol exemption request 146
must include a written explanation of the reason for the denial, 147
the clinical rationale that supports the denial, and the 148
procedure for appealing the health maintenance organization's 149
denial. 150
HB 459 2022
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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
3. A health maintenance organization may request relevant 151
medical records in support of a protocol exemption request. 152
(d)(c) This subsection does not require a health 153
maintenance organization to add a drug to its prescription drug 154
formulary or to cover a prescr iption drug that the health 155
maintenance organization does not otherwise cover. 156
Section 3. This act shall take effect July 1, 2022. 157