FL
Florida House Bill H1043

Florida 2023 Regular Session

Florida House Bill H1043 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
1515 An act relating to Medicaid coverage of rapid whole 2
1616 genome sequencing; creating s. 409.9063, F.S.; 3
1717 defining the term "rapid whole genome sequencing"; 4
1818 requiring the Agency for Health Care Administration, 5
1919 subject to federal approval, to include coverage of 6
2020 rapid whole genome sequencing as a separately payable 7
21-service for certain Medicaid recipients; requiring the 8
22-agency to adopt rules; providing an effective date. 9
23- 10
24-Be It Enacted by the Legislature of the State of Florida: 11
25- 12
26- Section 1. Section 409.9063, Florida Statutes, is created 13
27-to read: 14
28- 409.9063 Rapid whole genome sequencing services for 15
29-Medicaid recipients. — 16
30- (1) As used in this section, the term "rapi d whole genome 17
31-sequencing" means an investigation of the entire human genome, 18
32-including coding and noncoding regions and mitochondrial 19
33-deoxyribonucleic acid, to identify disease -causing genetic 20
34-changes which yields preliminary results within 5 days and the 21
35-final results within 14 days. The term includes patient -only 22
36-whole genome sequencing and duo and trio whole genome sequencing 23
37-of the patient and biological parent or parents. 24
38- (2) Subject to any required approval of the Centers for 25
21+service for certain Medicaid recipients; requiring 8
22+that genetic data generated as a result of the rapid 9
23+whole genome sequencing be used only for specified 10
24+purposes; providing for the use of such data in 11
25+scientific research if the patient or his or her legal 12
26+guardian provides express consent for that use; 13
27+providing for the rescission of such consent; 14
28+requiring the entities conducting the scientific 15
29+research, upon receipt of a written revocation of 16
30+consent, to cease use of the patient's data and 17
31+expunge it from any data repositories where it is 18
32+held; requiring the agency to seek federal approval to 19
33+amend current waivers, request a new waiver, and amend 20
34+contracts as necessary for a specified purpose; 21
35+requiring the agency to adopt rules; providing an 22
36+effective date. 23
37+ 24
38+Be It Enacted by the Legislature of the State of Florida: 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-Medicare and Medicaid Services, the agency shall include 26
52-coverage of rapid whole genome sequencing as a separately 27
53-payable service for a Medicaid recipient who: 28
54- (a) Is 20 years of age or younger; 29
55- (b) Has a complex or acute illness of unknown etiology 30
56-which is confirmed not to have been caused by an environmental 31
57-exposure, a toxic ingestion, an infection with normal response 32
58-to therapy, or trauma; and 33
59- (c) Is receiving inpatient hospital services in an 34
60-intensive care unit or a high -acuity pediatric care unit. 35
61- (3) The agency shall adopt rules to implement this 36
62-section. 37
63- Section 2. This act shall take effect July 1, 2023. 38
51+ 26
52+ Section 1. Section 409.9063, Flori da Statutes, is created 27
53+to read: 28
54+ 409.9063 Rapid whole genome sequencing services for 29
55+Medicaid recipients. — 30
56+ (1) As used in this section, the term "rapid whole genome 31
57+sequencing" means an investigation of the entire human genome, 32
58+including coding and non coding regions and mitochondrial 33
59+deoxyribonucleic acid, to identify disease -causing genetic 34
60+changes which yields preliminary results within 5 days and the 35
61+final results within 14 days. The term includes patient -only 36
62+whole genome sequencing and duo and trio whole genome sequencing 37
63+of the patient and biological parent or parents. 38
64+ (2) Subject to any required approval of the Centers for 39
65+Medicare and Medicaid Services, the agency shall include 40
66+coverage of rapid whole genome sequencing as a separately 41
67+payable service for a Medicaid recipient who: 42
68+ (a) Is 20 years of age or younger; 43
69+ (b) Has a complex or acute illness of unknown etiology 44
70+which is confirmed not to have been caused by an environmental 45
71+exposure, a toxic ingestion, an infection with normal response 46
72+to therapy, or trauma; and 47
73+ (c) Is receiving inpatient hospital services in an 48
74+intensive care unit or a high -acuity pediatric care unit. 49
75+ (3)(a) Except as specified in paragraph (b), genetic data 50
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84+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+generated as a result of performing rapid whole genome 51
89+sequencing covered by this section must be used only to assist 52
90+the ordering health care professional and treating care team in 53
91+diagnosing and treating the patient. As protected health 54
92+information, this patient genetic data is subject to the privacy 55
93+provisions of the federal Health Insurance Portability and 56
94+Accountability Act of 1996 and its implementing regulations. 57
95+ (b) Genetic data generated from rapid whole genome 58
96+sequencing covered under this section may be used in scientific 59
97+research if the patient, or the patient's legal guardian if the 60
98+patient is a minor, has given express consent for that use of 61
99+the data. A patient or patient's legal guardian, as applicable, 62
100+has the right to rescind the original consent to the use of the 63
101+data in scientific research at any time, and upon receipt of a 64
102+written revocation of the consent, the health care provider or 65
103+other entity using the data must cease its use of the data and 66
104+expunge the data from any data repository where it is held. 67
105+ (4) The agency shall seek approval to amend current 68
106+waivers, request a new waiver, and amend contracts as necessary 69
107+to provide for coverage of services under this section. 70
108+ (5) The agency shall adopt rules to implement this 71
109+section. 72
110+ Section 2. This act shall take effect July 1, 2023. 73