Florida 2025 Regular Session

Florida House Bill H1335 Compare Versions

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1010 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
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1414 A bill to be entitled 1
15-An act relating to biomarker testing; amending s. 2
16-409.906, F.S.; revising the definition of the term 3
17-"biomarker testing"; requiring the Agency for Health 4
18-Care Administration to establish a provider 5
19-reimbursement schedule and billing codes for a 6
20-specified medical services and procedures coding to 7
21-cover biomarker testing; authorizing Medicaid program 8
22-coverage of certain colorectal cancer tests; amending 9
23-s. 409.9745, F.S.; requiring Medicaid managed care 10
24-plans to cover certain colorectal cancer tests at a 11
25-certain level; requiring the agency to contract for a 12
26-cost-benefit analysis; providing requirements for the 13
27-analysis; providing reporting requirements; providing 14
28-for future repeal; providing an effective date. 15
29- 16
30-Be It Enacted by the Legislature of the State of Florida: 17
31- 18
32- Section 1. Paragraphs (b), (c), and (d) of subsection (29) 19
33-of section 409.906, Florida Statutes, are amended to read: 20
34- 409.906 Optional Medi caid services.—Subject to specific 21
35-appropriations, the agency may make payments for services which 22
36-are optional to the state under Title XIX of the Social Security 23
37-Act and are furnished by Medicaid providers to recipients who 24
38-are determined to be eligible on the dates on which the services 25
15+An act relating to coverage for colorectal cancer 2
16+screening and diagnosis; amending s. 408.9091, F.S.; 3
17+revising the colorectal screening requirements for 4
18+specified plans under the Cover Florida Health Care 5
19+Access Program; creating s. 627.64192, F.S.; defin ing 6
20+the term "cost sharing"; requiring specified 7
21+individual health insurance policies to provide 8
22+coverage for specified colorectal cancer screening 9
23+tests, procedures, and examinations under certain 10
24+circumstances; prohibiting individual health insurers 11
25+from imposing any cost sharing for such coverage; 12
26+providing applicability; creating s. 627.6614, F.S.; 13
27+defining the term "cost sharing"; requiring specified 14
28+group, blanket, and franchise health insurance 15
29+policies to provide coverage for specified colorectal 16
30+cancer screening tests, procedures, and examinations 17
31+under certain circumstances; prohibiting group, 18
32+blanket, and franchise health insurers from imposing 19
33+any cost sharing for such coverage; creating s. 20
34+641.31093, F.S.; defining the term "cost sharing"; 21
35+requiring specified health maintenance contracts to 22
36+provide coverage for specified colorectal cancer 23
37+screening tests, procedures, and examinations under 24
38+certain circumstances; prohibiting health maintenance 25
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4747 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
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51-were provided. Any optional service that is provided shall be 26
52-provided only when medically necessary and in accordance with 27
53-state and federal law. Optional services rendered by providers 28
54-in mobile units to Medicaid recipi ents may be restricted or 29
55-prohibited by the agency. Nothing in this section shall be 30
56-construed to prevent or limit the agency from adjusting fees, 31
57-reimbursement rates, lengths of stay, number of visits, or 32
58-number of services, or making any other adjustment s necessary to 33
59-comply with the availability of moneys and any limitations or 34
60-directions provided for in the General Appropriations Act or 35
61-chapter 216. If necessary to safeguard the state's systems of 36
62-providing services to elderly and disabled persons and s ubject 37
63-to the notice and review provisions of s. 216.177, the Governor 38
64-may direct the Agency for Health Care Administration to amend 39
65-the Medicaid state plan to delete the optional Medicaid service 40
66-known as "Intermediate Care Facilities for the Developmenta lly 41
67-Disabled." Optional services may include: 42
68- (29) BIOMARKER TESTING SERVICES. 43
69- (b) As used in this subsection, the term: 44
70- 1. "Biomarker" means a defined characteristic that is 45
71-measured as an indicator of normal biological processes, 46
72-pathogenic processes, or responses to an exposure or 47
73-intervention, including therapeutic interventions. The term 48
74-includes, but is not limited to, molecular, histologic, 49
75-radiographic, or physiologic characteristics but does not 50
51+organizations from imposing any cost sharing for such 26
52+coverage; providing applicability; providing an 27
53+effective date. 28
54+ 29
55+Be It Enacted by the Legislature of the State of Florida: 30
56+ 31
57+ Section 1. Paragraph (a) of subsection (4) of section 32
58+408.9091, Florida Statutes, is amended to read: 33
59+ 408.9091 Cover Flori da Health Care Access Program. — 34
60+ (4) PROGRAM.—The agency and the office shall jointly 35
61+establish and administer the Cover Florida Health Care Access 36
62+Program. 37
63+ (a) General Cover Florida plan components must require 38
64+that: 39
65+ 1. Plans are offered on a guarant eed-issue basis to 40
66+enrollees, subject to exclusions for preexisting conditions 41
67+approved by the office and the agency. 42
68+ 2. Plans are portable such that the enrollee remains 43
69+covered regardless of employment status or the cost sharing of 44
70+premiums. 45
71+ 3. Plans provide for cost containment through limits on 46
72+the number of services, caps on benefit payments, and copayments 47
73+for services. 48
74+ 4. A Cover Florida plan entity makes all benefit plan and 49
75+marketing materials available in English and Spanish. 50
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8484 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
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88-include an assessment of how a patient feels, functions, or 51
89-survives. 52
90- 2. "Biomarker testing" means an analysis of a patient's 53
91-tissue, blood, or other biospecimen for the presence of a 54
92-biomarker. The term includes, but is not limited to, single 55
93-analyte tests, multiplex panel tests, protein expression , and 56
94-whole exome, whole genome, and whole transcriptome sequencing 57
95-that are: 58
96- a. Billed under either Current Procedural Terminology or 59
97-Proprietary Laboratory Analyses codes; and 60
98- b. Performed at a participating in -network laboratory 61
99-facility that is cer tified pursuant to the federal Clinical 62
100-Laboratory Improvement Amendment (CLIA) or that has obtained a 63
101-CLIA Certificate of Waiver by the United States Food and Drug 64
102-Administration for the tests. 65
103- 3. "Clinical utility" means the test result provides 66
104-information that is used in the formulation of a treatment or 67
105-monitoring strategy that informs a patient's outcome and impacts 68
106-the clinical decision. 69
107- (c) A recipient and participating provider shall have 70
108-access to a clear and convenient process to request 71
109-authorization for biomarker testing as provided under this 72
110-subsection. Such process shall be made readily accessible to all 73
111-recipients and participating providers online. By August 1, 74
112-2025, the agency shall establish a provider reimbursement 75
88+ 5. In order to provide for consumer choice, Cover Florida 51
89+plan entities develop two alternative benefit option plans 52
90+having different cost and benefit levels, including at least one 53
91+plan that provides catastrophic coverage. 54
92+ 6. Plans without catastrophic coverage prov ide coverage 55
93+options for services including, but not limited to: 56
94+ a. Preventive health services, including immunizations, 57
95+annual health assessments, well -woman and well-care services, 58
96+and preventive screenings such as mammograms, cervical cancer 59
97+screenings, and noninvasive colorectal or prostate screenings, 60
98+and colorectal cancer screenings in accordance with s. 61
99+627.64192, s. 627.6614, or s. 641.31093 . 62
100+ b. Incentives for routine preventive care. 63
101+ c. Office visits for the diagnosis and treatment of 64
102+illness or injury. 65
103+ d. Office surgery, including anesthesia. 66
104+ e. Behavioral health services. 67
105+ f. Durable medical equipment and prosthetics. 68
106+ g. Diabetic supplies. 69
107+ 7. Plans providing catastrophic coverage, at a minimum, 70
108+provide coverage options for all of the services listed under 71
109+subparagraph 6.; however, such plans may include, but are not 72
110+limited to, coverage options for: 73
111+ a. Inpatient hospital stays. 74
112+ b. Hospital emergency care services. 75
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121121 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
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125-schedule and billing codes for the Proprietary Laboratory 76
126-Analyses codes to cover biomarker testing as provided in this 77
127-subsection. 78
128- (d) This subsection does not require coverage of biomarker 79
129-testing for screening purposes. The agency may pay for medically 80
130-necessary blood-based biomarker tests for colorectal cancer 81
131-screening. 82
132- Section 2. Section 409.9745, Florida Statutes, is amended 83
133-to read: 84
134- 409.9745 Managed care plan biomarker testing. 85
135- (1) A managed care plan must provide coverage for 86
136-biomarker testing for recipients, as authorized under s. 87
137-409.906, at the same scope, duration, and frequency as the 88
138-Medicaid program provides for other medically necessary 89
139-treatments. 90
140- (a)(2) A recipient and health care provider shall have 91
141-access to a clear and convenient proc ess to request 92
142-authorization for biomarker testing as provided under this 93
143-section. Such process shall be made readily accessible on the 94
144-website of the managed care plan. 95
145- (b)(3) This section does not require coverage of biomarker 96
146-testing for screening pur poses. 97
147- (c)(4) The agency shall include the rate impact of this 98
148-section in the applicable Medicaid managed medical assistance 99
149-program and long-term care managed care program rates. 100
125+ c. Urgent care services. 76
126+ d. Outpatient facility services, ou tpatient surgery, and 77
127+outpatient diagnostic services. 78
128+ 8. All plans offer prescription drug benefit coverage, use 79
129+a prescription drug manager, or offer a discount drug card. 80
130+ 9. Plan enrollment materials provide information in plain 81
131+language on policy be nefit coverage, benefit limits, cost -82
132+sharing requirements, and exclusions and a clear representation 83
133+of what is not covered in the plan. Such enrollment materials 84
134+must include a standard disclosure form adopted by rule by the 85
135+Financial Services Commission, to be reviewed and executed by 86
136+all consumers purchasing Cover Florida plan coverage. 87
137+ 10. Plans offered through a qualified employer meet the 88
138+requirements of s. 125 of the Internal Revenue Code. 89
139+ Section 2. Section 627.64192, Florida Statutes, is crea ted 90
140+to read: 91
141+ 627.64192 Coverage for colorectal cancer screening and 92
142+diagnosis.— 93
143+ (1) As used in this section, the term "cost sharing" 94
144+includes copayments, coinsurance, dollar limits, and deductibles 95
145+imposed on the covered person. The term does not inclu de 96
146+premiums. 97
147+ (2)(a) A health insurance policy issued, amended, 98
148+delivered, or renewed on or after January 1, 2026, must provide 99
149+coverage for a colorectal cancer screening test, procedure, or 100
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158158 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
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162- (2) A managed care plan must provide coverage for 101
163-medically necessary bl ood-based biomarker tests for colorectal 102
164-cancer screening at the same scope and frequency as the Medicaid 103
165-program provides for other medically necessary tests or 104
166-screenings for colorectal cancer. 105
167- Section 3. The Agency for Health Care Administration mus t 106
168-contract for an independent, actuarially sound 5 -year 107
169-comparative cost-benefit analysis of the cost -effectiveness of 108
170-providing coverage of blood -based biomarker tests for colorectal 109
171-cancer in the Medicaid program. The analysis must address, at a 110
172-minimum, the following factors: 111
173- (1) Data on the utilization of blood -based biomarker tests 112
174-for colorectal cancer screening and other tests or screenings 113
175-for colorectal cancer, including fecal immunochemical tests, 114
176-fecal occult blood tests, stool DNA tests, and c olonoscopies, 115
177-and the total costs of such tests or screenings, broken out by 116
178-type. 117
179- (2) Numeric and demographic data on recipients who 118
180-received inpatient or outpatient treatment for colorectal 119
181-cancer, total costs of such treatment, and total costs of oth er 120
182-medically necessary care provided which was related to the 121
183-colorectal cancer diagnosis. 122
184- (3) Data on cost avoidance, if any, attributable to the 123
185-use of blood-based biomarker tests for colorectal cancer, 124
186-including, but not limited to, cost avoidance due to 125
162+examination conducted by a health care provider which is: 101
163+ 1.a. Approved by the United States Food and Drug 102
164+Administration and meets the requirements of the National 103
165+Coverage Determination 210.3 made by the Centers for Medicare 104
166+and Medicaid Services; or 105
167+ b. In accordance with the most recent or most recently 106
168+published guidelines and recommendations established by the 107
169+American Cancer Society for the ages, family histories, and 108
170+frequencies referenced in such guidelines and recommendations; 109
171+and 110
172+ 2. Deemed appropriate by the attending physician after 111
173+conferring with the patient. 112
174+ (b) The health insurer may not impose any cost sharing on 113
175+the insured for the coverage of a colorectal cancer screening 114
176+test, procedure, or examination described in paragraph (a), 115
177+regardless of whether the test, procedure, or examination is 116
178+conducted by an in-network or out-of-network health care 117
179+provider. 118
180+ (3) This section does not apply to a nonrenewable health 119
181+insurance policy written for a period of less than 6 months. 120
182+ Section 3. Section 627.6614, Florida Statutes, is created 121
183+to read: 122
184+ 627.6614 Coverage for colorectal cancer screening and 123
185+diagnosis.— 124
186+ (1) As used in this section, the term "cost sharing" 125
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195195 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
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199-substitution for more costly tests and due to reductions in 126
200-treatment cost attributable to earlier diagnosis. 127
201- (4) Data on deaths of Medicaid recipients attributable to 128
202-colorectal cancer or a complication from colorectal cancer over 129
203-the term of the study. 130
204- 131
205-The agency must submit an interim report by November 30, 2028, 132
206-and a final report by November 30, 2030, respectively, to the 133
207-Governor, the President of the Senate, and the Speaker of the 134
208-House of Representatives. 135
209- Section 4. The provisions of this act amending s. 136
210-409.906(29)(d), Florida Statutes, and s. 409.9745, Florida 137
211-Statutes, shall stand repealed on July 1, 2031, unless saved 138
212-from repeal through reenactment by the Legislature. 139
213- Section 5. This act shall take effect upon becoming a law. 140
199+includes copayments, coinsurance, dollar limits, and deductibles 126
200+imposed on the covered person. The term does not include 127
201+premiums. 128
202+ (2)(a) A health insurance policy issued, amended, 129
203+delivered, or renewed on or after January 1, 2026, must provide 130
204+coverage for a colorectal cancer screening test, procedure, or 131
205+examination conducted by a health care provider which is: 132
206+ 1.a. Approved by the United States Food and Drug 133
207+Administration and meets the requirements of the National 134
208+Coverage Determination 210.3 made by the Centers for Medicare 135
209+and Medicaid Services; or 136
210+ b. In accordance with the most recent or most recently 137
211+published guidelines and recommendations established by the 138
212+American Cancer Society for the ages, family histories, and 139
213+frequencies referenced in such guidelines and recommendations; 140
214+and 141
215+ 2. Deemed appropriate by the attending physician after 142
216+conferring with the patient. 143
217+ (b) The health insurer may not impose any cost sharing on 144
218+the insured for the coverage of a colorectal cancer screening 145
219+test, procedure, or examination described in paragraph (a), 146
220+regardless of whether the test, procedure, or examination is 147
221+conducted by an in-network or out-of-network health care 148
222+provider. 149
223+ Section 4. Section 641.31093, Florida Statutes, is created 150
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232+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
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236+to read: 151
237+ 641.31093 Coverage for colorectal cancer screening and 152
238+diagnosis.— 153
239+ (1) As used in this section, the term "cost sharing" 154
240+includes copayments, coinsurance, dollar limits, and deductibles 155
241+imposed on the covered person. The term does not include 156
242+premiums. 157
243+ (2)(a) A health maintenance contract issued, amended, 158
244+delivered, or renewed on or after January 1, 2026, must provide 159
245+coverage for a colorectal cancer screening test, procedure, or 160
246+examination conducted by a health care provider which is: 161
247+ 1.a. Approved by the United States Food and Drug 162
248+Administration and meets the requirements of the National 163
249+Coverage Determination 210.3 made by th e Centers for Medicare 164
250+and Medicaid Services; or 165
251+ b. In accordance with the most recent or most recently 166
252+published guidelines and recommendations established by the 167
253+American Cancer Society for the ages, family histories, and 168
254+frequencies referenced in such guidelines and recommendations; 169
255+and 170
256+ 2. Deemed appropriate by the attending physician after 171
257+conferring with the patient. 172
258+ (b) The health maintenance organization may not impose any 173
259+cost sharing on the subscriber for the coverage of a colorectal 174
260+cancer screening test, procedure, or examination described in 175
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269+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
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273+paragraph (a), regardless of whether the test, procedure, or 176
274+examination is conducted by an in -network or out-of-network 177
275+health care provider. 178
276+ (3) This section does not apply to a nonrenewable 179
277+individual health maintenance contract written for a period of 180
278+less than 6 months. 181
279+ Section 5. This act shall take effect July 1, 2025. 182