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
HB 805 2023
1 A bill to be entitled
2 An act relating to health insurance coverage for
3 biomarker testing; amending s. 409.905, F.S.;
4 requiring the Agency for Health Care Administration to
5 pay for biomarker testing under the Medicaid program
6 under specified conditions; providing requirements fo r
7 covered biomarker testing; requiring notification on
8 utilization review request determinations within
9 specified timeframes; requiring access to request
10 process for exceptions to coverage and to certain
11 adverse determinations; requiring such process to be
12 posted on the agency's website; providing definitions;
13 amending s. 409.973, F.S.; requiring managed care
14 plans to cover biomarker testing under the Medicaid
15 program; creating ss. 627.64094, 627.65742, 641.31078,
16 and 641.5143, F.S.; requiring certain individual
17 health insurance policies, group health insurance
18 policies, health maintenance contracts, and prepaid
19 health clinic contracts, respectively, and certain
20 health services, health care, and health benefit plans
21 to provide coverage for biomarker testing; providing
22 requirements for covered biomarker testing; requiring
23 notification on utilization review request
24 determinations within specified timeframes; requiring
25 access to request process for exceptions to coverage
Page 1 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
26 and to certain adverse determinations; requiring such
27 process to be posted on the entities' websites;
28 providing an effective date.
29
30 Be It Enacted by the Legislature of the State of Florida:
31
32 Section 1. Subsection (2) of section 409.905, Florida
33 Statutes, is amended to read:
34 409.905 Mandatory Medicaid services.—The agency may make
35 payments for the following services, which are required of the
36 state by Title XIX of the Social Security Act, furnished by
37 Medicaid providers to recipients who are determined to be
38 eligible on the dates on which the services were provided. Any
39 service under this section shall be provided only when medically
40 necessary and in accordance with state and federal law.
41 Mandatory services rendered by providers in mobile units to
42 Medicaid recipients may be restricted by the agency. Nothing in
43 this section shall be construed to prevent or limit the agency
44 from adjusting fees, reimbursement rates, lengths of stay,
45 number of visits, number of services, or any other adjustments
46 necessary to comply with the availability of moneys and any
47 limitations or directions provided for in the General
48 Appropriations Act or chapter 216.
49 (2) EARLY AND PERIODIC SCREENING, DIAGNOSIS, AND TREATMENT
50 SERVICES; BIOMARKER TESTING.—
Page 2 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
51 (a) The agency shall pay for early and periodic screening
52 and diagnosis of a recipient under age 21 to ascertain physical
53 and mental problems and conditions and all services determined
54 by the agency to be medically necessary for the treatment,
55 correction, or amelioration of these problems and conditions,
56 including personal care, private duty nursing, durable medical
57 equipment, physical therapy, occupational therapy, speech
58 therapy, respiratory therapy, and immunizations.
59 (b) Subject to the approval of the Centers for Medicare
60 and Medicaid Services, the agency shall pay for biomarker
61 testing for the purposes of diagnosis, treatment, appropriate
62 management, or ongoing monitoring of a recipient's disease or
63 condition.
64 1. The biomarker testing covered under this paragraph must
65 be supported by medical and scientific evidence. Such evidence
66 includes, but is not limited to:
67 a. Labeled indications for a United States Food and Drug
68 Administration-approved or Food and Drug Administration-cleared
69 test;
70 b. Indicated tests for a Food and Drug Administration-
71 approved drug;
72 c. Warnings and precautions on Food and Drug
73 Administration-approved drug labels;
74 d. The Centers for Medicare and Medicaid Services national
75 coverage determinations or Medicare Administrative Contractor
Page 3 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
76 local coverage determinations; or
77 e. Nationally recognized clinical practice guidelines and
78 consensus statements.
79 2. The biomarker testing covered under this paragraph must
80 be provided in a manner that limits disruptions in care,
81 including tests to remove multiple biopsies or biospecimen
82 samples.
83 3. If utilization review, including, but not limited to,
84 prior authorization, is required, the utilization review
85 committee or any third party acting on behalf of the agency must
86 approve or deny a utilization review request, including, but not
87 limited to, a prior authorization request, and must notify the
88 recipient, the recipient's health care provider, and any entity
89 requesting authorization of the biomarker testing within 72
90 hours for a nonurgent request and within 24 hours for an urgent
91 request after receipt of the request.
92 4. The recipient and the prescribing health care provider
93 must have access to a clear, readily accessible, and convenient
94 process to request an exception to the coverage or an adverse
95 utilization review determination of the agency. The process
96 shall be made readily accessible on the agency's website.
97 5. As used in this paragraph, the terms "biomarker,"
98 "biomarker testing," "consensus statements," and "nationally
99 recognized practice guidelines" have the same meanings as in s.
100 627.64094.
Page 4 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
101 Section 2. Paragraph (dd) is added to subsection (1) of
102 section 409.973, Florida Statutes, to read:
103 409.973 Benefits.—
104 (1) MINIMUM BENEFITS.—Managed care plans shall cover, at a
105 minimum, the following services:
106 (dd) Biomarker testing, as defined in s. 627.64094.
107 Section 3. Section 627.64094, Florida Statutes, is created
108 to read:
109 627.64094 Coverage for biomarker testing.—
110 (1) As used in this section, the term:
111 (a) "Biomarker" means a characteristic that is objectively
112 measured and evaluated as an indicator of normal biological
113 processes, pathogenic processes, or pharmacologic responses to a
114 specific therapeutic intervention, including known gene -drug
115 interactions for medications being considered for use or already
116 being administered. The term includes, but is not limited to,
117 gene mutations, characteristics of genes, and protein
118 expression.
119 (b) "Biomarker testing" is the analysis of a patient's
120 tissue, blood, or other biospecimen for the presence of a
121 biomarker. The term includes, but is not limited to, single-
122 analyte tests, multiplex panel tests, protein expression, and
123 whole exome, whole genome, and whole transcriptome sequencing.
124 (c) "Consensus statements" means statements developed by
125 an independent, multidisciplinary panel of experts using a
Page 5 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
126 transparent methodology and reporting structure and with a
127 conflict of interest policy. These statements are aimed at
128 specific clinical circumstances and base the statements on the
129 best available evidence for the purpose of optimizing the
130 outcomes of clinical care.
131 (d) "Nationally recognized clinical practice guidelines"
132 means evidence-based clinical practice guidelines developed by
133 independent organizations or medical professional societies
134 using a transparent methodology and reporting structure and with
135 a conflict of interest policy. The guidelines establish
136 standards of care informed by a systematic review of evidence
137 and an assessment of the benefits and risks of alternative care
138 options and include recommendations intended to optimize patien t
139 care.
140 (2) A health insurance policy, a nonprofit health services
141 plan or nonprofit health care plan, as defined in s. 628.703,
142 and a health benefit plan, as defined in s. 627.6699(3), issued,
143 amended, delivered, or renewed in this state, or providing
144 prepaid health care in this state, on or after July 1, 2023,
145 must include coverage for biomarker testing for the purposes of
146 diagnosis, treatment, appropriate management, or ongoing
147 monitoring of an insured's disease or condition.
148 (a) The biomarker testing covered under this subsection
149 must be supported by medical and scientific evidence. Such
150 evidence includes, but is not limited to:
Page 6 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
151 1. Labeled indications for a United States Food and Drug
152 Administration-approved or Food and Drug Administration-cleared
153 test;
154 2. Indicated tests for a Food and Drug Administration-
155 approved drug;
156 3. Warnings and precautions on Food and Drug
157 Administration-approved drug labels;
158 4. The Centers for Medicare and Medicaid Services national
159 coverage determinations or Medicare Administrative Contractor
160 local coverage determinations; or
161 5. Nationally recognized clinical practice guidelines and
162 consensus statements.
163 (b) The biomarker testing covered under this subsection
164 must be provided in a manner that limits disruptions in care,
165 including tests to remove multiple biopsies or biospecimen
166 samples.
167 (c) If utilization review, including, but not limited to,
168 prior authorization, is required, the utilization review
169 committee or any third party acting on behalf of the health
170 insurer, the nonprofit health services plan or nonprofit health
171 care plan, and the health benefit plan subject to this
172 subsection must approve or deny a utilization review request,
173 including, but not limited to, a prior authorization request,
174 and must notify the insured, the insured's health care provider,
175 and any entity requesting authorization of the biomarker testing
Page 7 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
176 within 72 hours for a nonurgent request and within 24 hours for
177 an urgent request after receipt of the request.
178 (e) The insured and the prescribing health care provider
179 must have access to a clear, readily accessible, and convenient
180 process to request an exception to the policy coverage or an
181 adverse utilization review determination of the health insurer,
182 the nonprofit health services plan or nonprofit health care
183 plan, and the health benefit plan. The process shall be made
184 readily accessible on the website of the health insurer, the
185 nonprofit health services plan or nonprofit health care plan,
186 and the health benefit plan.
187 Section 4. Section 627.65742, Florida Statutes, is created
188 to read:
189 627.65742 Coverage for biomarker testing.—
190 (1) As used in this section, the term:
191 (a) "Biomarker" means a characteristic that is objectively
192 measured and evaluated as an indicator of normal biologica l
193 processes, pathogenic processes, or pharmacologic responses to a
194 specific therapeutic intervention, including known gene -drug
195 interactions for medications being considered for use or already
196 being administered. The term includes, but is not limited to,
197 gene mutations, characteristics of genes, and protein
198 expression.
199 (b) "Biomarker testing" is the analysis of a patient's
200 tissue, blood, or other biospecimen for the presence of a
Page 8 of 17
CODING: Words stricken are deletions; words underlined are additions.
hb0805-00
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
HB 805 2023
201 biomarker. The term includes, but is not limited to, single-
202 analyte tests, multiplex panel tests, protein expression, and
203 whole exome, whole genome, and whole transcriptome sequencing.
204 (c) "Consensus statements" means statements developed by
205 an independent, multidisciplinary panel of experts using a
206 transparent methodology and reporting structure and with a
207 conflict of interest policy. These statements are aimed at
208 specific clinical circumstances and base the statements on the
209 best available evidence for the purpose of optimizing the
210 outcomes of clinical care.
211 (d) "Nationally recognized clinical practice guidelines"
212 means evidence-based clinical practice guidelines developed by
213 independent organizations or medical professional societies
214 using a transparent methodology and reporting structure and with
215 a conflict of interest policy. The guidelines establish
216 standards of care informed by a systematic review of ev