15 | | - | An act relating to biomarker testing; amending s. 2 |
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16 | | - | 409.906, F.S.; revising the definition of the term 3 |
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17 | | - | "biomarker testing"; requiring the Agency for Health 4 |
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18 | | - | Care Administration to establish a provider 5 |
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19 | | - | reimbursement schedule and billing codes for a 6 |
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20 | | - | specified medical services and procedures coding to 7 |
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21 | | - | cover biomarker testing; authorizing Medicaid program 8 |
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22 | | - | coverage of certain colorectal cancer tests; amending 9 |
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23 | | - | s. 409.9745, F.S.; requiring Medicaid managed care 10 |
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24 | | - | plans to cover certain colorectal cancer tests at a 11 |
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25 | | - | certain level; requiring the agency to contract for a 12 |
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26 | | - | cost-benefit analysis; providing requirements for the 13 |
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27 | | - | analysis; providing reporting requirements; providing 14 |
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28 | | - | for future repeal; providing an effective date. 15 |
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29 | | - | 16 |
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30 | | - | Be It Enacted by the Legislature of the State of Florida: 17 |
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31 | | - | 18 |
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32 | | - | Section 1. Paragraphs (b), (c), and (d) of subsection (29) 19 |
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33 | | - | of section 409.906, Florida Statutes, are amended to read: 20 |
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34 | | - | 409.906 Optional Medi caid services.—Subject to specific 21 |
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35 | | - | appropriations, the agency may make payments for services which 22 |
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36 | | - | are optional to the state under Title XIX of the Social Security 23 |
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37 | | - | Act and are furnished by Medicaid providers to recipients who 24 |
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38 | | - | are determined to be eligible on the dates on which the services 25 |
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| 15 | + | An act relating to coverage for colorectal cancer 2 |
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| 16 | + | screening and diagnosis; amending s. 408.9091, F.S.; 3 |
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| 17 | + | revising the colorectal screening requirements for 4 |
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| 18 | + | specified plans under the Cover Florida Health Care 5 |
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| 19 | + | Access Program; creating s. 627.64192, F.S.; defin ing 6 |
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| 20 | + | the term "cost sharing"; requiring specified 7 |
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| 21 | + | individual health insurance policies to provide 8 |
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| 22 | + | coverage for specified colorectal cancer screening 9 |
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| 23 | + | tests, procedures, and examinations under certain 10 |
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| 24 | + | circumstances; prohibiting individual health insurers 11 |
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| 25 | + | from imposing any cost sharing for such coverage; 12 |
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| 26 | + | providing applicability; creating s. 627.6614, F.S.; 13 |
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| 27 | + | defining the term "cost sharing"; requiring specified 14 |
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| 28 | + | group, blanket, and franchise health insurance 15 |
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| 29 | + | policies to provide coverage for specified colorectal 16 |
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| 30 | + | cancer screening tests, procedures, and examinations 17 |
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| 31 | + | under certain circumstances; prohibiting group, 18 |
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| 32 | + | blanket, and franchise health insurers from imposing 19 |
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| 33 | + | any cost sharing for such coverage; creating s. 20 |
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| 34 | + | 641.31093, F.S.; defining the term "cost sharing"; 21 |
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| 35 | + | requiring specified health maintenance contracts to 22 |
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| 36 | + | provide coverage for specified colorectal cancer 23 |
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| 37 | + | screening tests, procedures, and examinations under 24 |
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| 38 | + | certain circumstances; prohibiting health maintenance 25 |
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51 | | - | were provided. Any optional service that is provided shall be 26 |
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52 | | - | provided only when medically necessary and in accordance with 27 |
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53 | | - | state and federal law. Optional services rendered by providers 28 |
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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 |
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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 |
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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 |
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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 |
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65 | | - | the Medicaid state plan to delete the optional Medicaid service 40 |
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66 | | - | known as "Intermediate Care Facilities for the Developmenta lly 41 |
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67 | | - | Disabled." Optional services may include: 42 |
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68 | | - | (29) BIOMARKER TESTING SERVICES. — 43 |
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69 | | - | (b) As used in this subsection, the term: 44 |
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70 | | - | 1. "Biomarker" means a defined characteristic that is 45 |
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71 | | - | measured as an indicator of normal biological processes, 46 |
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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 |
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| 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 |
---|
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 |
---|
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 |
---|
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 |
---|
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 |
---|
| 224 | + | |
---|
| 225 | + | HB 1335 2025 |
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| 226 | + | |
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| 227 | + | |
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| 228 | + | |
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| 229 | + | CODING: Words stricken are deletions; words underlined are additions. |
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| 230 | + | hb1335-00 |
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| 231 | + | Page 7 of 8 |
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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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| 233 | + | |
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| 234 | + | |
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| 235 | + | |
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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 |
---|
| 261 | + | |
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| 262 | + | HB 1335 2025 |
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| 263 | + | |
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| 264 | + | |
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| 265 | + | |
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| 266 | + | CODING: Words stricken are deletions; words underlined are additions. |
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| 267 | + | hb1335-00 |
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| 268 | + | Page 8 of 8 |
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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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| 270 | + | |
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| 271 | + | |
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| 272 | + | |
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| 273 | + | paragraph (a), regardless of whether the test, procedure, or 176 |
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| 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 |
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| 277 | + | individual health maintenance contract written for a period of 180 |
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| 278 | + | less than 6 months. 181 |
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| 279 | + | Section 5. This act shall take effect July 1, 2025. 182 |
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