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ENGROSSED HOUSE
BILL NO. 1576 By: Lawson of the House
and
Hicks of the Senate
[ Medicaid - Oklahoma Health Care Authority -
coverage – criteria – Health Information
Portability and Accountability Act requirements -
scientific research - waiver application –
codification - effective date –
emergency]
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 4005 of Title 56, unless there
is created a duplication in numbering, reads as follows:
A. For purposes of this section, "rapid whole genome
sequencing" is defined as an investigation of the entire human
genome, including coding and non -coding regions and mitochondrial
deoxyribonucleic acid, to identify disease -causing genetic changes
that returns the preliminary positive results within seven (7) days
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and final results within fifteen (15) to twenty -one (21) days from
the date of receipt of the sample by the lab performing th e test,
and includes patient -only whole genome sequencing (WGS) and duo and
trio whole genome sequencing of the patient and biological parent or
parents.
B. Subject to any required approval of the Centers for Medicare
and Medicaid Services, the Oklahoma H ealth Care Authority shall
include coverage of rapid whole genome sequencing as a separately
payable service for Medicaid beneficiaries when all of the following
criteria are met:
1. Beneficiary is under twenty -one (21) years of age;
2. Beneficiary has a complex or acute illness of unknown
etiology, that is not confirmed to be caused by an environmental
exposure, toxic ingestion, infection with normal response to
therapy, or trauma; and
3. Beneficiary is receiving hospital services in an intensive
care unit or other high acuity care unit within a hospital.
C. The coverage provided pursuant to this section may be
subject to applicable evidence -based medical necessity criteria that
shall be based on all of the following:
1. The patient has symptoms that s uggest a broad differential
diagnosis that would require an evaluation by multiple genetic tests
if rapid whole genome sequencing is not performed;
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2. The patient's treating health care provider has determined
that timely identification of a molecular dia gnosis is necessary to
guide clinical decision -making and testing results may guide the
treatment or management of the patient 's condition; and
3. The patient has a complex or acute illness of unknown
etiology, including at least one of the following cond itions:
a. congenital anomalies involving at least two organ
systems or complex and multiple congenital anomalies
in one organ system,
b. specific organ malformations highly suggestive of a
genetic etiology,
c. abnormal laboratory tests or abnormal chemist ry
profiles suggesting the presence of a genetic disease,
complex metabolic disorder, or inborn error of
metabolism,
d. refractory or severe hypoglycemia or hyperglycemia,
e. abnormal response to therapy related to an underlying
medical condition affecting vital organs or bodily
systems,
f. severe muscle weakness, rigidity, or spasticity,
g. refractory seizures,
h. a high-risk stratification on evaluation for a brief
resolved unexplained event with any of the following:
(1) a recurrent event without respira tory infection,
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(2) a recurrent event witnessed seizure -like event,
or
(3) a recurrent cardiopulmonary resuscitation ,
i. abnormal cardiac diagnostic testing results suggestive
of possible channelopathies, arrhythmias,
cardiomyopathies, myocarditis, or stru ctural heart
disease,
j. abnormal diagnostic imaging studies suggestive of an
underlying genetic condition,
k. abnormal physiologic function studies suggestive of an
underlying genetic etiology, or
l. family genetic history related to the patient 's
condition.
D. Nothing in this section prohibits the Chief Operating
Officer of the Oklahoma Health Care Authority from adding additional
conditions to those contained in paragraph 3 of subsection C of this
section based upon new medical evidence or from providin g coverage
for rapid whole genome sequencing or other next generation
sequencing (NGS) and genetic testing for Medicaid beneficiaries that
is in addition to the coverage required under this section.
E. Genetic data generated as a result of performing rapi d whole
genome sequencing, covered pursuant to this section, shall have a
primary use of assisting the ordering health care professional and
treating care team to diagnose and treat the patient, and as
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protected health information , it shall be subject to t he
requirements applicable to protected health information as set forth
in the Health Information Portability and Accountability Act
(HIPAA), the Health Information Technology for Economic and Clinical
Health Act, and their attendant regulations, including , but not
limited to, the HIPAA privacy rule as promulgated at 45 CFR , Part
160 and Subparts A and E of 45 CFR , Part 164.
F. Genetic data generated from rapid whole genome sequencing,
covered pursuant to this section, can be used in scientific research
if consent for such use of the data has been expressly given by the
patient, or the patient 's legal guardian in the case of a minor.
The patient, the patient 's legal guardian in the case of a minor, or
the patient's health care provider with the patient 's consent, may
request access to the results of the testing covered by this section
for use in other clinical settings. A health care provider may only
charge a small fee to the patient based on the direct costs of
producing the results in a format usable in other clinical settings.
A patient, or patient 's legal guardian in the case of a minor, shall
have the right to rescind the original consent to the use of the
data in scientific research at any time, and upon receipt of a
written revocation of the consen t, the health care provider or other
entity using the data shall cease use and expunge the data from any
data repository where it is held.
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G. The Chief Operating Officer of the Oklahoma Health Care
Authority shall take any actions necessary to implement t he
provisions of this section, which may include, if deemed necessary,
the following:
1. Promulgation of rules and regulations to provide for
Medicaid coverage pursuant to this section;
2. Submission to the Centers for Medicare and Medicaid Services
of any new waiver application, amendment to an existing waiver, or
Medicaid state plan amendment necessary to ensure federal financial
participation for Medicaid coverage pursuant to this section; or
3. Any other administrative action determined by the Chief
Operating Officer as necessary to implement the requirements of this
section.
SECTION 2. This act shall become effective July 1, 2025.
SECTION 3. It being immediately necessary for the preservation
of the public peace, hea lth or safety, an emergency is hereby
declared to exist, by reason whereof this act shall take effect and
be in full force from and after its passage and approval.
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Passed the House of Representatives the 3rd day of March, 2025.
Presiding Officer of t he House
of Representatives
Passed the Senate the ____ day of __________, 2025.
Presiding Officer of the Senate