Florida Senate - 2022 SB 730 By Senator Harrell 25-00777A-22 2022730__ 1 A bill to be entitled 2 An act relating to step-therapy protocols; amending s. 3 627.42393, F.S.; revising the circumstances under 4 which step-therapy protocols may not be required; 5 defining terms; requiring health insurers to publish 6 on their websites and provide to their insureds 7 specified information; providing requirements for 8 procedures for requests and appeals of denials of 9 protocol exemptions; providing requirements for 10 authorizations and denials of protocol exemption 11 requests; authorizing health insurers to request 12 specified documentation under certain circumstances; 13 amending s. 641.31, F.S.; revising the circumstances 14 under which step-therapy protocols may not be 15 required; defining terms; requiring health maintenance 16 organizations to publish on their websites and provide 17 to their subscribers specified information; providing 18 requirements for procedures for requests and appeals 19 of denials of protocol exemptions; providing 20 requirements for authorizations and denials of 21 protocol exemption requests; authorizing health 22 maintenance organizations to request specified 23 documentation under certain circumstances; providing 24 an effective date. 25 26 Be It Enacted by the Legislature of the State of Florida: 27 28 Section 1.Section 627.42393, Florida Statutes, is amended 29 to read: 30 627.42393Step-therapy protocol. 31 (2)(1)In addition to the protocol exemptions granted 32 pursuant to subsection (3), a health insurer issuing a major 33 medical individual or group policy may not require a step 34 therapy protocol under the policy for a covered prescription 35 drug requested by an insured if: 36 (a)The insured has previously been approved to receive the 37 prescription drug through the completion of a step-therapy 38 protocol required by a separate health coverage plan; and 39 (b)The insured provides documentation originating from the 40 health coverage plan that approved the prescription drug as 41 described in paragraph (a) indicating that the health coverage 42 plan paid for the drug on the insureds behalf during the 90 43 days immediately before the request. 44 (1)(2)As used in this section, the term: 45 (a)Health coverage plan means any of the following which 46 is currently or was previously providing major medical or 47 similar comprehensive coverage or benefits to the insured: 48 1.(a)A health insurer or health maintenance organization. 49 2.(b)A plan established or maintained by an individual 50 employer as provided by the Employee Retirement Income Security 51 Act of 1974, Pub. L. No. 93-406. 52 3.(c)A multiple-employer welfare arrangement as defined in 53 s. 624.437. 54 4.(d)A governmental entity providing a plan of self 55 insurance. 56 (b)Protocol exemption means a determination by a health 57 insurer to authorize the use of another prescription drug, 58 medical procedure, or course of treatment prescribed or 59 recommended by the treating health care provider for the 60 insureds condition rather than the one specified by the health 61 insurers step-therapy protocol. 62 (c)Step-therapy protocol means a written protocol that 63 specifies the order in which certain prescription drugs, medical 64 procedures, or courses of treatment must be used to treat an 65 insureds condition. 66 (3)(a)A health insurer shall publish on its website and 67 provide to an insured in writing a procedure for the insured and 68 his or her health care provider to request a protocol exemption 69 or an appeal of the health insurers denial of a protocol 70 exemption request. The procedure must include, at a minimum: 71 1.The manner in which the insured or health care provider 72 may request a protocol exemption, including a form to request 73 the protocol exemption. 74 2.The manner and timeframe in which the health insurer 75 must authorize or deny a protocol exemption request, including 76 the requirement that such response must occur within a 77 reasonable time. 78 3.The manner and timeframe in which the insured or health 79 care provider may appeal the health insurers denial of a 80 protocol exemption request. 81 (b)An authorization of a protocol exemption request must 82 specify the approved prescription drug, medical procedure, or 83 course of treatment. A denial of a protocol exemption request 84 must include a written explanation of the reason for the denial, 85 the clinical rationale that supports the denial, and the 86 procedure for appealing the health insurers denial. 87 (c)A health insurer may request relevant medical records 88 in support of a protocol exemption request. 89 (4)(3)This section does not require a health insurer to 90 add a drug to its prescription drug formulary or to cover a 91 prescription drug that the insurer does not otherwise cover. 92 Section 2.Subsection (46) of section 641.31, Florida 93 Statutes, is amended to read: 94 641.31Health maintenance contracts. 95 (46)(b)(46)(a)In addition to the protocol exemptions 96 granted under paragraph (c), a health maintenance organization 97 issuing major medical coverage through an individual or group 98 contract may not require a step-therapy protocol under the 99 contract for a covered prescription drug requested by a 100 subscriber if: 101 1.The subscriber has previously been approved to receive 102 the prescription drug through the completion of a step-therapy 103 protocol required by a separate health coverage plan; and 104 2.The subscriber provides documentation originating from 105 the health coverage plan that approved the prescription drug as 106 described in subparagraph 1. indicating that the health coverage 107 plan paid for the drug on the subscribers behalf during the 90 108 days immediately before the request. 109 (a)(b)As used in this subsection, the term: 110 1.Health coverage plan means any of the following which 111 previously provided or is currently providing major medical or 112 similar comprehensive coverage or benefits to the subscriber: 113 a.1.A health insurer or health maintenance organization.; 114 b.2.A plan established or maintained by an individual 115 employer as provided by the Employee Retirement Income Security 116 Act of 1974, Pub. L. No. 93-406.; 117 c.3.A multiple-employer welfare arrangement as defined in 118 s. 624.437.; or 119 d.4.A governmental entity providing a plan of self 120 insurance. 121 2.Protocol exemption means a determination by a health 122 maintenance organization to authorize the use of another 123 prescription drug, medical procedure, or course of treatment 124 prescribed or recommended by the treating health care provider 125 for the subscribers condition rather than the one specified by 126 the health maintenance organizations step-therapy protocol. 127 3.Step-therapy protocol means a written protocol that 128 specifies the order in which certain prescription drugs, medical 129 procedures, or courses of treatment must be used to treat a 130 subscribers condition. 131 (c)1.A health maintenance organization shall publish on 132 its website and provide to a subscriber in writing a procedure 133 for the subscriber and his or her health care provider to 134 request a protocol exemption or an appeal of the health 135 maintenance organizations denial of a protocol exemption 136 request. The procedure must include, at a minimum: 137 a.The manner in which the subscriber or health care 138 provider may request a protocol exemption, including a form to 139 request the protocol exemption. 140 b.The manner and timeframe in which the health maintenance 141 organization must authorize or deny a protocol exemption 142 request, including the requirement that such response must occur 143 within a reasonable time. 144 c.The manner and timeframe in which the subscriber or 145 health care provider may appeal the health maintenance 146 organizations denial of a protocol exemption request. 147 2.An authorization of a protocol exemption request must 148 specify the approved prescription drug, medical procedure, or 149 course of treatment. A denial of a protocol exemption request 150 must include a written explanation of the reason for the denial, 151 the clinical rationale that supports the denial, and the 152 procedure for appealing the health maintenance organizations 153 denial. 154 3.A health maintenance organization may request relevant 155 medical records in support of a protocol exemption request. 156 (d)(c)This subsection does not require a health 157 maintenance organization to add a drug to its prescription drug 158 formulary or to cover a prescription drug that the health 159 maintenance organization does not otherwise cover. 160 Section 3.This act shall take effect July 1, 2022.