Okla. Stat. tit. 56, § 56-4005

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

and final results within fifteen (15) to twenty-one (21) days from

the date of receipt of the sample by the lab performing the 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 Health 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

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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 suggest a broad differential

diagnosis that would require an evaluation by multiple genetic tests

if rapid whole genome sequencing is not performed;

2. The patient's treating health care provider has determined

that timely identification of a molecular diagnosis 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 conditions:

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 chemistry

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 respiratory infection,

(2) a recurrent event witnessed seizure-like event,

or
e 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 respiratory infection,

(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 structural 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.

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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 providing 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 rapid 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

protected health information, it shall be subject to the

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 consent, 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.

G. The Chief Operating Officer of the Oklahoma Health Care

Authority shall take any actions necessary to implement the

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.

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