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.