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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
A bill to be entitled 1
An act relating to biomarker testing; amending s. 2
409.906, F.S.; revising the definition of the term 3
"biomarker testing"; requiring the Agency for Health 4
Care Administration to establish a provider 5
reimbursement schedule and billing codes for a 6
specified medical services and procedures coding to 7
cover biomarker testing; authorizing Medicaid program 8
coverage of certain colorectal cancer tests; amending 9
s. 409.9745, F.S.; requiring Medicaid managed care 10
plans to cover certain colorectal cancer tests at a 11
certain level; requiring the agency to contract for a 12
cost-benefit analysis; providing requirements for the 13
analysis; providing reporting requirements; providing 14
for future repeal; providing an effective date. 15
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Be It Enacted by the Legislature of the State of Florida: 17
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Section 1. Paragraphs (b), (c), and (d) of subsection (29) 19
of section 409.906, Florida Statutes, are amended to read: 20
409.906 Optional Medi caid services.—Subject to specific 21
appropriations, the agency may make payments for services which 22
are optional to the state under Title XIX of the Social Security 23
Act and are furnished by Medicaid providers to recipients who 24
are determined to be eligible on the dates on which the services 25
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were provided. Any optional service that is provided shall be 26
provided only when medically necessary and in accordance with 27
state and federal law. Optional services rendered by providers 28
in mobile units to Medicaid recipi ents may be restricted or 29
prohibited by the agency. Nothing in this section shall be 30
construed to prevent or limit the agency from adjusting fees, 31
reimbursement rates, lengths of stay, number of visits, or 32
number of services, or making any other adjustment s necessary to 33
comply with the availability of moneys and any limitations or 34
directions provided for in the General Appropriations Act or 35
chapter 216. If necessary to safeguard the state's systems of 36
providing services to elderly and disabled persons and s ubject 37
to the notice and review provisions of s. 216.177, the Governor 38
may direct the Agency for Health Care Administration to amend 39
the Medicaid state plan to delete the optional Medicaid service 40
known as "Intermediate Care Facilities for the Developmenta lly 41
Disabled." Optional services may include: 42
(29) BIOMARKER TESTING SERVICES. — 43
(b) 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
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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
that are: 58
a. Billed under either Current Procedural Terminology or 59
Proprietary Laboratory Analyses codes; and 60
b. Performed at a participating in -network laboratory 61
facility that is cer tified pursuant to the federal Clinical 62
Laboratory Improvement Amendment (CLIA) or that has obtained a 63
CLIA 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
(c) A recipient and participating provider shall have 70
access to a clear and convenient process to request 71
authorization for biomarker testing as provided under this 72
subsection. Such process shall be made readily accessible to all 73
recipients and participating providers online. By August 1, 74
2025, the agency shall establish a provider reimbursement 75
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schedule and billing codes for the Proprietary Laboratory 76
Analyses codes to cover biomarker testing as provided in this 77
subsection. 78
(d) This subsection does not require coverage of biomarker 79
testing for screening purposes. The agency may pay for medically 80
necessary blood-based biomarker tests for colorectal cancer 81
screening. 82
Section 2. Section 409.9745, Florida Statutes, is amended 83
to read: 84
409.9745 Managed care plan biomarker testing. — 85
(1) A managed care plan must provide coverage for 86
biomarker testing for recipients, as authorized under s. 87
409.906, at the same scope, duration, and frequency as the 88
Medicaid program provides for other medically necessary 89
treatments. 90
(a)(2) A recipient and health care provider shall have 91
access to a clear and convenient proc ess to request 92
authorization for biomarker testing as provided under this 93
section. Such process shall be made readily accessible on the 94
website of the managed care plan. 95
(b)(3) This section does not require coverage of biomarker 96
testing for screening pur poses. 97
(c)(4) The agency shall include the rate impact of this 98
section in the applicable Medicaid managed medical assistance 99
program and long-term care managed care program rates. 100
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(2) A managed care plan must provide coverage for 101
medically necessary bl ood-based biomarker tests for colorectal 102
cancer screening at the same scope and frequency as the Medicaid 103
program provides for other medically necessary tests or 104
screenings for colorectal cancer. 105
Section 3. The Agency for Health Care Administration mus t 106
contract for an independent, actuarially sound 5 -year 107
comparative cost-benefit analysis of the cost -effectiveness of 108
providing coverage of blood -based biomarker tests for colorectal 109
cancer in the Medicaid program. The analysis must address, at a 110
minimum, the following factors: 111
(1) Data on the utilization of blood -based biomarker tests 112
for colorectal cancer screening and other tests or screenings 113
for colorectal cancer, including fecal immunochemical tests, 114
fecal occult blood tests, stool DNA tests, and c olonoscopies, 115
and the total costs of such tests or screenings, broken out by 116
type. 117
(2) Numeric and demographic data on recipients who 118
received inpatient or outpatient treatment for colorectal 119
cancer, total costs of such treatment, and total costs of oth er 120
medically necessary care provided which was related to the 121
colorectal cancer diagnosis. 122
(3) Data on cost avoidance, if any, attributable to the 123
use of blood-based biomarker tests for colorectal cancer, 124
including, but not limited to, cost avoidance due to 125
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substitution for more costly tests and due to reductions in 126
treatment cost attributable to earlier diagnosis. 127
(4) Data on deaths of Medicaid recipients attributable to 128
colorectal cancer or a complication from colorectal cancer over 129
the term of the study. 130
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The agency must submit an interim report by November 30, 2028, 132
and a final report by November 30, 2030, respectively, to the 133
Governor, the President of the Senate, and the Speaker of the 134
House of Representatives. 135
Section 4. The provisions of this act amending s. 136
409.906(29)(d), Florida Statutes, and s. 409.9745, Florida 137
Statutes, shall stand repealed on July 1, 2031, unless saved 138
from repeal through reenactment by the Legislature. 139
Section 5. This act shall take effect upon becoming a law. 140