UNOFFICIAL COPY 25 RS BR 1087
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AN ACT relating to coverage for rapid whole genome sequencing. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
ď˘SECTION 1. A NEW SECTION OF KRS CHAPTER 18A IS CREATED TO 3
READ AS FOLLOWS: 4
(1) As used in this section, "rapid whole genome sequencing": 5
(a) Means an investigation of the entire human genome, including coding and 6
non-coding regions and mitochondrial deoxyribonucleic acid, to identify 7
disease-causing genetic changes that returns the preliminary positive results 8
within seven (7) days and final results within fifteen (15) days from the date 9
of receipt of the sample by the laboratory preforming the test; and 10
(b) Includes: 11
1. Patient-only whole genome sequencing; 12
2. Duo sequencing of the patient and one (1) biological parent; and 13
3. Trio sequencing of the patient and both biological parents. 14
(2) Notwithstanding any provision of law to the contrary, any fully insured or self-15
insured health benefit plan, as defined in KRS 304.17A-005, offered, issued, or 16
renewed to public employees under KRS 18A.225, 18A.2254, or any other 17
provision of this chapter shall provide coverage and reimbursement for rapid 18
whole genome sequencing when the insured: 19
(a) Is under twenty-one (21) years of age; 20
(b) Has a complex and acute illness of unknown etiology that is not confirmed 21
to be caused by environmental exposure, toxic ingestion, infection with 22
normal response to therapy, or trauma; and 23
(c) Is receiving hospital services in an intensive care unit or other high-acuity 24
care unit within a hospital. 25
(3) Coverage required under this section shall be subject to applicable evidence-26
based medical necessity criteria that shall include but may not be limited to: 27 UNOFFICIAL COPY 25 RS BR 1087
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(a) The patient has symptoms that suggest a broad differential diagnosis that 1
would require evaluation by multiple genetic tests if rapid whole genome 2
sequencing is not performed; 3
(b) The patient has a determination from the patient's treating healthcare 4
provider that: 5
1. Timely identification of a molecular diagnosis is necessary to guide 6
the clinical decision-making process; and 7
2. Testing results may guide treatment or management of the patient's 8
clinical condition; and 9
(c) The patient has a complex or acute illness of unknown etiology, including 10
at least one (1) of the following: 11
1. Congenital anomalies involving at least two (2) organ systems or 12
complex or multiple anomalies in one (1) organ system; 13
2. Specific organ malformations which are highly suggestive of a genetic 14
etiology; 15
3. Abnormal laboratory test results or abnormal chemistry profiles that 16
suggest the presence of a genetic disease, complex metabolic disorder, 17
or inborn error of metabolism; 18
4. Refractory or severe hypoglycemia or hyperglycemia; 19
5. Abnormal response to therapy related to an underlying medical 20
condition affecting vital organs or bodily systems; 21
6. Severe muscle weakness, rigidity, or spasticity; 22
7. Refractory seizures; 23
8. A high-risk stratification on evaluation for a brief resolved 24
unexplained event with: 25
a. A recurrent event without respiratory infection; 26
b. A recurrent witnessed seizure-like event; or 27 UNOFFICIAL COPY 25 RS BR 1087
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c. A recurrent cardiopulmonary resuscitation; 1
9. Abnormal cardiac diagnostic test results that suggest possible 2
channelopathies, arrhythmias, cardiomyopathies, myocarditis, or 3
structural heart disease; 4
10. Abnormal diagnostic imaging studies that suggest an underlying 5
genetic condition; 6
11. Abnormal physiologic function studies that suggest an underlying 7
genetic etiology; 8
12. A family history related to the patient's condition; or 9
13. Any other condition approved by the Department for Medicaid 10
Services based upon new medical evidence. 11
(4) (a) Genetic data generated from rapid whole genome sequencing covered under 12
this section has a primary use of assisting the ordering healthcare provider 13
and the treating care team to diagnose and treat the patient, is protected 14
health information, and is subject to the requirements of the federal Health 15
Insurance Portability and Accountability Act of 1996 and the federal Health 16
Information Technology for Economic and Clinical Health Act. 17
(b) Notwithstanding paragraph (a) of this subsection, genetic data generated 18
from rapid whole genome sequencing covered under this section may be 19
used in scientific research if informed consent for that use has been 20
expressly given by the patient, or the patient's legal guardian if the patient is 21
a minor. The patient, the patient's legal guardian, or the patient's 22
healthcare provider with the patient's informed consent may request access 23
to the results of the testing covered under this section for use in other 24
clinical settings. 25
(c) A patient, or a patient's legal guardian if the patient is a minor, may rescind 26
informed consent given under paragraph (b) of this subsection for the use 27 UNOFFICIAL COPY 25 RS BR 1087
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of genetic data in scientific research at any time. Upon receipt of a written 1
revocation of consent, the patient's healthcare provider and any other 2
individual or entity using the genetic data shall cease use and expunge all of 3
the patient's genetic data from any data repository where the data is held. 4