Florida Senate - 2024 CS for CS for SB 964 By the Appropriations Committee on Health and Human Services; the Committee on Banking and Insurance; and Senator Calatayud 603-03307-24 2024964c2 1 A bill to be entitled 2 An act relating to coverage for biomarker testing; 3 amending s. 110.12303, F.S.; defining terms; requiring 4 the Department of Management Services to provide 5 coverage of biomarker testing for specified purposes 6 for state employees’ state group health insurance plan 7 policies issued on or after a specified date; 8 specifying circumstances under which such coverage may 9 be provided; requiring state group health insurance 10 plans to provide enrollees and participating providers 11 with a clear and convenient process for authorization 12 requests for biomarker testing; requiring that such 13 process be readily accessible online; providing 14 construction; amending s. 409.906, F.S.; defining 15 terms; authorizing the Agency for Health Care 16 Administration to pay for biomarker testing under the 17 Medicaid program for specified purposes, subject to 18 specific appropriations; specifying circumstances 19 under which such payments may be made; requiring that 20 Medicaid recipients and participating providers be 21 provided a clear and convenient process for 22 authorization requests for biomarker testing; 23 requiring that such process be readily accessible 24 online; providing construction; authorizing the agency 25 to seek federal approval for biomarker testing 26 payments; creating s. 409.9745, F.S.; requiring 27 managed care plans under contract with the agency in 28 the Medicaid program to provide coverage for biomarker 29 testing for Medicaid recipients in a certain manner; 30 requiring managed care plans to provide Medicaid 31 recipients and health care providers with a clear and 32 convenient process for authorization requests for 33 biomarker testing; requiring that such process be 34 readily accessible on the managed care plan’s website; 35 providing construction; requiring the agency to 36 include the rate impact of the act in certain rates 37 that become effective on a specified date; providing 38 an effective date. 39 40 Be It Enacted by the Legislature of the State of Florida: 41 42 Section 1. Subsection (5) is added to section 110.12303, 43 Florida Statutes, to read: 44 110.12303 State group insurance program; additional 45 benefits; price transparency program; reporting.— 46 (5)(a) As used in this subsection, the term: 47 1. “Biomarker” means a defined characteristic that is 48 measured as an indicator of normal biological processes, 49 pathogenic processes, or responses to an exposure or 50 intervention, including therapeutic interventions. The term 51 includes, but is not limited to, molecular, histologic, 52 radiographic, or physiologic characteristics but does not 53 include an assessment of how a patient feels, functions, or 54 survives. 55 2. “Biomarker testing” means an analysis of a patient’s 56 tissue, blood, or other biospecimen for the presence of a 57 biomarker. The term includes, but is not limited to, single 58 analyte tests, multiplex panel tests, protein expression, and 59 whole exome, whole genome, and whole transcriptome sequencing 60 performed at a participating in-network laboratory facility that 61 is certified pursuant to the federal Clinical Laboratory 62 Improvement Amendment (CLIA) or that has obtained a CLIA 63 Certificate of Waiver by the United States Food and Drug 64 Administration for the tests. 65 3. “Clinical utility” means the test result provides 66 information that is used in the formulation of a treatment or 67 monitoring strategy that informs a patient’s outcome and impacts 68 the clinical decision. 69 (b) For state group health insurance plan policies issued 70 on or after January 1, 2025, the department shall provide 71 coverage of biomarker testing for the purposes of diagnosis, 72 treatment, appropriate management, or ongoing monitoring of an 73 enrollee’s disease or condition to guide treatment decisions if 74 medical and scientific evidence indicates that the biomarker 75 testing provides clinical utility to the enrollee. Such medical 76 and scientific evidence includes, but is not limited to: 77 1. A labeled indication for a test approved or cleared by 78 the United States Food and Drug Administration; 79 2. An indicated test for a drug approved by the United 80 States Food and Drug Administration; 81 3. A national coverage determination made by the Centers 82 for Medicare and Medicaid Services or a local coverage 83 determination made by the Medicare Administrative Contractor; or 84 4. A nationally recognized clinical practice guideline. As 85 used in this subparagraph, the term “nationally recognized 86 clinical practice guideline” means an evidence-based clinical 87 practice guideline developed by independent organizations or 88 medical professional societies using a transparent methodology 89 and reporting structure and with a conflict-of-interest policy. 90 Guidelines developed by such organizations or societies 91 establish standards of care informed by a systematic review of 92 evidence and an assessment of the benefits and costs of 93 alternative care options and include recommendations intended to 94 optimize patient care. 95 (c) Each state group health insurance plan shall provide 96 enrollees and participating providers with a clear and 97 convenient process to request authorization for biomarker 98 testing. Such process must be made readily accessible online to 99 all enrollees and participating providers. 100 (d) This subsection does not require coverage of biomarker 101 testing for screening purposes. 102 Section 2. Subsection (29) is added to section 409.906, 103 Florida Statutes, to read: 104 409.906 Optional Medicaid services.—Subject to specific 105 appropriations, the agency may make payments for services which 106 are optional to the state under Title XIX of the Social Security 107 Act and are furnished by Medicaid providers to recipients who 108 are determined to be eligible on the dates on which the services 109 were provided. Any optional service that is provided shall be 110 provided only when medically necessary and in accordance with 111 state and federal law. Optional services rendered by providers 112 in mobile units to Medicaid recipients may be restricted or 113 prohibited by the agency. Nothing in this section shall be 114 construed to prevent or limit the agency from adjusting fees, 115 reimbursement rates, lengths of stay, number of visits, or 116 number of services, or making any other adjustments necessary to 117 comply with the availability of moneys and any limitations or 118 directions provided for in the General Appropriations Act or 119 chapter 216. If necessary to safeguard the state’s systems of 120 providing services to elderly and disabled persons and subject 121 to the notice and review provisions of s. 216.177, the Governor 122 may direct the Agency for Health Care Administration to amend 123 the Medicaid state plan to delete the optional Medicaid service 124 known as “Intermediate Care Facilities for the Developmentally 125 Disabled.” Optional services may include: 126 (29) BIOMARKER TESTING SERVICES.— 127 (a) As used in this subsection, the term: 128 1. “Biomarker” means a defined characteristic that is 129 measured as an indicator of normal biological processes, 130 pathogenic processes, or responses to an exposure or 131 intervention, including therapeutic interventions. The term 132 includes, but is not limited to, molecular, histologic, 133 radiographic, or physiologic characteristics but does not 134 include an assessment of how a patient feels, functions, or 135 survives. 136 2. “Biomarker testing” means an analysis of a patient’s 137 tissue, blood, or other biospecimen for the presence of a 138 biomarker. The term includes, but is not limited to, single 139 analyte tests, multiplex panel tests, protein expression, and 140 whole exome, whole genome, and whole transcriptome sequencing 141 performed at a participating in-network laboratory facility that 142 is certified pursuant to the federal Clinical Laboratory 143 Improvement Amendment (CLIA) or that has obtained a CLIA 144 Certificate of Waiver by the United States Food and Drug 145 Administration for the tests. 146 3. “Clinical utility” means the test result provides 147 information that is used in the formulation of a treatment or 148 monitoring strategy that informs a patient’s outcome and impacts 149 the clinical decision. 150 (b) The agency may pay for biomarker testing for the 151 purposes of diagnosis, treatment, appropriate management, or 152 ongoing monitoring of a recipient’s disease or condition to 153 guide treatment decisions if medical and scientific evidence 154 indicates that the biomarker testing provides clinical utility 155 to the recipient. Such medical and scientific evidence includes, 156 but is not limited to: 157 1. A labeled indication for a test approved or cleared by 158 the Unites States Food and Drug Administration; 159 2. An indicated test for a drug approved by the United 160 States Food and Drug Administration; 161 3. A national coverage determination made by the Centers 162 for Medicare and Medicaid Services or a local coverage 163 determination made by the Medicare Administrative Contractor; or 164 4. A nationally recognized clinical practice guideline. As 165 used in this subparagraph, the term “nationally recognized 166 clinical practice guideline” means an evidence-based clinical 167 practice guideline developed by independent organizations or 168 medical professional societies using a transparent methodology 169 and reporting structure and with a conflict-of-interest policy. 170 Guidelines developed by such organizations or societies 171 establish standards of care informed by a systematic review of 172 evidence and an assessment of the benefits and costs of 173 alternative care options and include recommendations intended to 174 optimize patient care. 175 (c) Recipients and participating providers must be provided 176 access to a clear and convenient process to request 177 authorization for biomarker testing as provided under this 178 subsection. Such process must be made readily accessible online 179 to all recipients and participating providers. 180 (d) This subsection does not require coverage of biomarker 181 testing for screening purposes. 182 (e) The agency may seek federal approval necessary to 183 implement this subsection. 184 Section 3. Section 409.9745, Florida Statutes, is created 185 to read: 186 409.9745 Managed care plan biomarker testing.— 187 (1) A managed care plan must provide coverage for biomarker 188 testing for recipients, as authorized under s. 409.906, at the 189 same scope, duration, and frequency as the Medicaid program 190 provides for other medically necessary treatments. 191 (2) The managed care plan shall provide recipients and 192 health care providers with access to a clear and convenient 193 process to request authorization for biomarker testing as 194 provided under this section. Such process must be made readily 195 accessible on the managed care plan’s website. 196 (3) This section does not require coverage of biomarker 197 testing for screening purposes. 198 Section 4. The Agency for Health Care Administration is 199 directed to include the rate impact of this act in the 200 applicable Medicaid managed medical assistance program and long 201 term care managed care program rates that become effective on 202 October 1, 2024. 203 Section 5. This act shall take effect October 1, 2024.