Florida Senate - 2023 SB 616
By Senator Yarborough
4-00579B-23 2023616__
1 A bill to be entitled
2 An act relating to Medicaid coverage of rapid whole
3 genome sequencing; creating s. 409.9063, F.S.;
4 defining the term “rapid whole genome sequencing”;
5 requiring the Agency for Health Care Administration,
6 subject to federal approval, to include coverage of
7 rapid whole genome sequencing as a separately payable
8 service for certain Medicaid recipients; requiring
9 that genetic data generated as a result of the rapid
10 whole genome sequencing be used only for specified
11 purposes; providing for the use of such data in
12 scientific research if the patient or his or her legal
13 guardian provides express consent for that use;
14 providing for the rescission of such consent;
15 requiring the entities conducting the scientific
16 research, upon receipt of a written revocation of
17 consent, to cease use of the patient’s data and
18 expunge it from any data repositories where it is
19 held; requiring the agency to seek federal approval to
20 amend current waivers, request a new waiver, and amend
21 contracts as necessary for a specified purpose;
22 requiring the agency to adopt rules; providing an
23 effective date.
24
25 WHEREAS, rapid whole genome sequencing is a powerful
26 diagnostic tool for individuals with rare genetic conditions in
27 which the specific genetic etiology is unclear, and
28 WHEREAS, rapid whole genome sequencing for critically ill
29 children with an undiagnosed condition who are receiving
30 treatment in an intensive care unit demonstrates significant
31 clinical utility, is cost-effective, and yields life-changing
32 outcomes when ordered as a first-line test, and
33 WHEREAS, studies have shown that with rapid whole genome
34 sequencing, providers have been able to identify the exact cause
35 of rare genetic diseases in a matter of days, instead of the
36 standard 4 to 6 weeks that other genetic testing currently
37 offers, and this allows providers to deliver timely treatment
38 tailored to the child’s specific condition, and
39 WHEREAS, access to the results of rapid whole genome
40 sequencing empowers parents to join providers in making the most
41 informed care decisions, thereby avoiding other costly tests and
42 invasive procedures, which is shown to result in fewer days
43 spent in the hospital, and
44 WHEREAS, if ordered by the provider, rapid whole genome
45 sequencing should be covered by all plans in this state when
46 clinical criteria are met, NOW, THEREFORE,
47
48 Be It Enacted by the Legislature of the State of Florida:
49
50 Section 1. Section 409.9063, Florida Statutes, is created
51 to read:
52 409.9063 Rapid whole genome sequencing services for
53 Medicaid recipients.—
54 (1) As used in this section, the term “rapid whole genome
55 sequencing” means an investigation of the entire human genome,
56 including coding and noncoding regions and mitochondrial
57 deoxyribonucleic acid, to identify disease-causing genetic
58 changes which yields preliminary results within 5 days and the
59 final results within 14 days. The term includes patient-only
60 whole genome sequencing and duo and trio whole genome sequencing
61 of the patient and biological parent or parents.
62 (2) Subject to any required approval of the Centers for
63 Medicare and Medicaid Services, the agency shall include
64 coverage of rapid whole genome sequencing as a separately
65 payable service for a Medicaid recipient who:
66 (a) Is 21 years of age or younger;
67 (b) Has a complex or acute illness of unknown etiology
68 which is confirmed not to have been caused by an environmental
69 exposure, a toxic ingestion, an infection with normal response
70 to therapy, or trauma; and
71 (c) Is receiving inpatient hospital services in an
72 intensive care unit or a high-acuity pediatric care unit.
73 (3)(a) Except as specified in paragraph (b), genetic data
74 generated as a result of performing rapid whole genome
75 sequencing covered by this section must be used only to assist
76 the ordering health care professional and treating care team in
77 diagnosing and treating the patient. As protected health
78 information, this patient genetic data is subject to the privacy
79 provisions of the federal Health Insurance Portability and
80 Accountability Act of 1996 and its implementing regulations.
81 (b) Genetic data generated from rapid whole genome
82 sequencing covered under this section may be used in scientific
83 research if the patient, or the patient’s legal guardian if the
84 patient is a minor, has given express consent for that use of
85 the data. A patient or patient’s legal guardian, as applicable,
86 has the right to rescind the original consent to the use of the
87 data in scientific research at any time, and upon receipt of a
88 written revocation of the consent, the health care provider or
89 other entity using the data must cease its use of the data and
90 expunge the data from any data repository where it is held.
91 (4) The agency shall seek approval to amend current
92 waivers, request a new waiver, and amend contracts as necessary
93 to provide for coverage of services under this section.
94 (5) The agency shall adopt rules to implement this section.
95 Section 2. This act shall take effect July 1, 2023.