Florida Senate - 2024 CS for SB 964
By the Committee on Banking and Insurance; and Senator Calatayud
597-03029-24 2024964c1
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; providing an effective date.
36
37 Be It Enacted by the Legislature of the State of Florida:
38
39 Section 1. Subsection (5) is added to section 110.12303,
40 Florida Statutes, to read:
41 110.12303 State group insurance program; additional
42 benefits; price transparency program; reporting.—
43 (5)(a) As used in this subsection, the term:
44 1. “Biomarker” means a defined characteristic that is
45 measured as an indicator of normal biological processes,
46 pathogenic processes, or responses to an exposure or
47 intervention, including therapeutic interventions. The term
48 includes, but is not limited to, molecular, histologic,
49 radiographic, or physiologic characteristics but does not
50 include an assessment of how a patient feels, functions, or
51 survives.
52 2. “Biomarker testing” means an analysis of a patient’s
53 tissue, blood, or other biospecimen for the presence of a
54 biomarker. The term includes, but is not limited to, single
55 analyte tests, multiplex panel tests, protein expression, and
56 whole exome, whole genome, and whole transcriptome sequencing
57 performed at a participating in-network laboratory facility that
58 is certified pursuant to the federal Clinical Laboratory
59 Improvement Amendment (CLIA) or that has obtained a CLIA
60 Certificate of Waiver by the United States Food and Drug
61 Administration for the tests.
62 3. “Clinical utility” means the test result provides
63 information that is used in the formulation of a treatment or
64 monitoring strategy that informs a patient’s outcome and impacts
65 the clinical decision.
66 (b) For state group health insurance plan policies issued
67 on or after January 1, 2025, the department shall provide
68 coverage of biomarker testing for the purposes of diagnosis,
69 treatment, appropriate management, or ongoing monitoring of an
70 enrollee’s disease or condition to guide treatment decisions if
71 medical and scientific evidence indicates that the biomarker
72 testing provides clinical utility to the enrollee. Such medical
73 and scientific evidence includes, but is not limited to:
74 1. A labeled indication for a test approved or cleared by
75 the United States Food and Drug Administration;
76 2. An indicated test for a drug approved by the United
77 States Food and Drug Administration;
78 3. A national coverage determination made by the Centers
79 for Medicare and Medicaid Services or a local coverage
80 determination made by the Medicare Administrative Contractor; or
81 4. A nationally recognized clinical practice guideline. As
82 used in this subparagraph, the term “nationally recognized
83 clinical practice guideline” means an evidence-based clinical
84 practice guideline developed by independent organizations or
85 medical professional societies using a transparent methodology
86 and reporting structure and with a conflict-of-interest policy.
87 Guidelines developed by such organizations or societies
88 establish standards of care informed by a systematic review of
89 evidence and an assessment of the benefits and costs of
90 alternative care options and include recommendations intended to
91 optimize patient care.
92 (c) Each state group health insurance plan shall provide
93 enrollees and participating providers with a clear and
94 convenient process to request authorization for biomarker
95 testing. Such process must be made readily accessible online to
96 all enrollees and participating providers.
97 (d) This subsection does not require coverage of biomarker
98 testing for screening purposes.
99 Section 2. Subsection (29) is added to section 409.906,
100 Florida Statutes, to read:
101 409.906 Optional Medicaid services.—Subject to specific
102 appropriations, the agency may make payments for services which
103 are optional to the state under Title XIX of the Social Security
104 Act and are furnished by Medicaid providers to recipients who
105 are determined to be eligible on the dates on which the services
106 were provided. Any optional service that is provided shall be
107 provided only when medically necessary and in accordance with
108 state and federal law. Optional services rendered by providers
109 in mobile units to Medicaid recipients may be restricted or
110 prohibited by the agency. Nothing in this section shall be
111 construed to prevent or limit the agency from adjusting fees,
112 reimbursement rates, lengths of stay, number of visits, or
113 number of services, or making any other adjustments necessary to
114 comply with the availability of moneys and any limitations or
115 directions provided for in the General Appropriations Act or
116 chapter 216. If necessary to safeguard the state’s systems of
117 providing services to elderly and disabled persons and subject
118 to the notice and review provisions of s. 216.177, the Governor
119 may direct the Agency for Health Care Administration to amend
120 the Medicaid state plan to delete the optional Medicaid service
121 known as “Intermediate Care Facilities for the Developmentally
122 Disabled.” Optional services may include:
123 (29) BIOMARKER TESTING SERVICES.—
124 (a) As used in this subsection, the term:
125 1. “Biomarker” means a defined characteristic that is
126 measured as an indicator of normal biological processes,
127 pathogenic processes, or responses to an exposure or
128 intervention, including therapeutic interventions. The term
129 includes, but is not limited to, molecular, histologic,
130 radiographic, or physiologic characteristics but does not
131 include an assessment of how a patient feels, functions, or
132 survives.
133 2. “Biomarker testing” means an analysis of a patient’s
134 tissue, blood, or other biospecimen for the presence of a
135 biomarker. The term includes, but is not limited to, single
136 analyte tests, multiplex panel tests, protein expression, and
137 whole exome, whole genome, and whole transcriptome sequencing
138 performed at a participating in-network laboratory facility that
139 is certified pursuant to the federal Clinical Laboratory
140 Improvement Amendment (CLIA) or that has obtained a CLIA
141 Certificate of Waiver by the United States Food and Drug
142 Administration for the tests.
143 3. “Clinical utility” means the test result provides
144 information that is used in the formulation of a treatment or
145 monitoring strategy that informs a patient’s outcome and impacts
146 the clinical decision.
147 (b) The agency may pay for biomarker testing for the
148 purposes of diagnosis, treatment, appropriate management, or
149 ongoing monitoring of a recipient’s disease or condition to
150 guide treatment decisions if medical and scientific evidence
151 indicates that the biomarker testing provides clinical utility
152 to the recipient. Such medical and scientific evidence includes,
153 but is not limited to:
154 1. A labeled indication for a test approved or cleared by
155 the Unites States Food and Drug Administration;
156 2. An indicated test for a drug approved by the United
157 States Food and Drug Administration;
158 3. A national coverage determination made by the Centers
159 for Medicare and Medicaid Services or a local coverage
160 determination made by the Medicare Administrative Contractor; or
161 4. A nationally recognized clinical practice guideline. As
162 used in this subparagraph, the term “nationally recognized
163 clinical practice guideline” means an evidence-based clinical
164 practice guideline developed by independent organizations or
165 medical professional societies using a transparent methodology
166 and reporting structure and with a conflict-of-interest policy.
167 Guidelines developed by such organizations or societies
168 establish standards of care informed by a systematic review of
169 evidence and an assessment of the benefits and costs of
170 alternative care options and include recommendations intended to
171 optimize patient care.
172 (c) Recipients and participating providers must be provided
173 access to a clear and convenient process to request
174 authorization for biomarker testing as provided under this
175 subsection. Such process must be made readily accessible online
176 to all recipients and participating providers.
177 (d) This subsection does not require coverage of biomarker
178 testing for screening purposes.
179 (e) The agency may seek federal approval necessary to
180 implement this subsection.
181 Section 3. Section 409.9745, Florida Statutes, is created
182 to read:
183 409.9745 Managed care plan biomarker testing.—
184 (1) A managed care plan must provide coverage for biomarker
185 testing for recipients, as authorized under s. 409.906, at the
186 same scope, duration, and frequency as the Medicaid program
187 provides for other medically necessary treatments.
188 (2) The managed care plan shall provide recipients and
189 health care providers with access to a clear and convenient
190 process to request authorization for biomarker testing as
191 provided under this section. Such process must be made readily
192 accessible on the managed care plan’s website.
193 (3) This section does not require coverage of biomarker
194 testing for screening purposes.
195 Section 4. This act shall take effect July 1, 2024.