HB 1043 2023
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hb1043-00
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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 Medicaid coverage of rapid whole 2
genome sequencing; creating s. 409.9063, F.S.; 3
defining the term "rapid whole genome sequencing"; 4
requiring the Agency for Health Care Administration, 5
subject to federal approval, to include coverage of 6
rapid whole genome sequencing as a separately payable 7
service for certain Medicaid recipients; requiring 8
that genetic data generated as a result of the rapid 9
whole genome sequencing be used only for specified 10
purposes; providing for the use of such data in 11
scientific research if the patient or his or her legal 12
guardian provides express consent for that use; 13
providing for the rescission of such consent; 14
requiring the entities conducting the scientific 15
research, upon receipt of a written revocation of 16
consent, to cease use of the patient's data and 17
expunge it from any data repositories where it is 18
held; requiring the agency to seek federal approval to 19
amend current waivers, request a new waiver, and amend 20
contracts as necessary for a specified purpose; 21
requiring the agency to adopt rules; providing an 22
effective date. 23
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WHEREAS, rapid whole genome sequencing is a powerful 25
HB 1043 2023
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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
diagnostic tool for individuals w ith rare genetic conditions in 26
which the specific genetic etiology is unclear, and 27
WHEREAS, rapid whole genome sequencing for critically ill 28
children with an undiagnosed condition who are receiving 29
treatment in an intensive care unit demonstrates signific ant 30
clinical utility, is cost -effective, and yields life -changing 31
outcomes when ordered as a first -line test, and 32
WHEREAS, studies have shown that with rapid whole genome 33
sequencing, providers have been able to identify the exact cause 34
of rare genetic diseases in a matter of days, instead of the 35
standard 4 to 6 weeks that other genetic testing currently 36
offers, and this allows providers to deliver timely treatment 37
tailored to the child's specific condition, and 38
WHEREAS, access to the results of rapid whol e genome 39
sequencing empowers parents to join providers in making the most 40
informed care decisions, thereby avoiding other costly tests and 41
invasive procedures, which is shown to result in fewer days 42
spent in the hospital, and 43
WHEREAS, if ordered by the pr ovider, rapid whole genome 44
sequencing should be covered by all plans in this state when 45
clinical criteria are met, NOW, THEREFORE, 46
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Be It Enacted by the Legislature of the State of Florida: 48
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Section 1. Section 409.9063, Florida Statutes, is created 50
HB 1043 2023
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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
to read: 51
409.9063 Rapid whole genome sequencing services for 52
Medicaid recipients. — 53
(1) As used in this section, the term "rapid whole genome 54
sequencing" means an investigation of the entire human genome, 55
including coding and noncoding regions and mitoch ondrial 56
deoxyribonucleic acid, to identify disease -causing genetic 57
changes which yields preliminary results within 5 days and the 58
final results within 14 days. The term includes patient -only 59
whole genome sequencing and duo and trio whole genome sequencing 60
of the patient and biological parent or parents. 61
(2) Subject to any required approval of the Centers for 62
Medicare and Medicaid Services, the agency shall include 63
coverage of rapid whole genome sequencing as a separately 64
payable service for a Medicaid rec ipient who: 65
(a) Is 21 years of age or younger; 66
(b) Has a complex or acute illness of unknown etiology 67
which is confirmed not to have been caused by an environmental 68
exposure, a toxic ingestion, an infection with normal response 69
to therapy, or trauma; a nd 70
(c) Is receiving inpatient hospital services in an 71
intensive care unit or a high -acuity pediatric care unit. 72
(3)(a) Except as specified in paragraph (b), genetic data 73
generated as a result of performing rapid whole genome 74
sequencing covered by this section must be used only to assist 75
HB 1043 2023
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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
the ordering health care professional and treating care team in 76
diagnosing and treating the patient. As protected health 77
information, this patient genetic data is subject to the privacy 78
provisions of the federal Health Insurance Portability and 79
Accountability Act of 1996 and its implementing regulations. 80
(b) Genetic data generated from rapid whole genome 81
sequencing covered under this section may be used in scientific 82
research if the patient, o r the patient's legal guardian if the 83
patient is a minor, has given express consent for that use of 84
the data. A patient or patient's legal guardian, as applicable, 85
has the right to rescind the original consent to the use of the 86
data in scientific research at any time, and upon receipt of a 87
written revocation of the consent, the health care provider or 88
other entity using the data must cease its use of the data and 89
expunge the data from any data repository where it is held. 90
(4) The agency shall seek approva l to amend current 91
waivers, request a new waiver, and amend contracts as necessary 92
to provide for coverage of services under this section. 93
(5) The agency shall adopt rules to implement this 94
section. 95
Section 2. This act shall take effect July 1, 2023. 96