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AN ACT relating to coverage for biomarker testing. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF SUBTITLE 17A OF KRS CHAPTER 304 3
IS CREATED TO READ AS FOLLOWS: 4
(1) As used in this section: 5
(a) "Biomarker": 6
1. Means a characteristic that is objectively measured and evaluated as 7
an indicator of normal biologic processes, pathogenic processes, or 8
pharmacologic responses to a specific therapeutic intervention, 9
including known gene-drug interactions for medications being 10
considered for use or already being administered; and 11
2. Includes but is not limited to gene mutations and protein expression; 12
(b) "Biomarker testing": 13
1. Means the analysis of a patient's tissue, blood, or other biospecimen 14
for the presence of a biomarker; and 15
2. Includes but is not limited to single-analyte tests, multiplex panel tests, 16
and whole genome sequencing; 17
(c) "Consensus statements" means statements that are: 18
1. Developed by an independent, multidisciplinary panel of experts 19
utilizing a transparent methodology and reporting structure with a 20
conflict of interest policy; 21
2. Aimed at specific clinical circumstances; and 22
3. Based on the best available evidence for the purpose of optimizing the 23
outcomes of clinical care; 24
(d) "FDA" means the United States Food and Drug Administration; and 25
(e) "Nationally recognized clinical practice guidelines" means evidence-based 26
clinical practice guidelines that: 27 UNOFFICIAL COPY 23 RS BR 229
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1. Are developed by an independent organization or medical professional 1
society utilizing a transparent methodology and reporting structure 2
with a conflict of interest policy; 3
2. Establish standards of care informed by: 4
a. A systematic review of evidence; and 5
b. An assessment of the benefits and risks of alternative care 6
options; and 7
3. Include recommendations intended to optimize care. 8
(2) A health benefit plan shall provide coverage for biomarker testing when ordered 9
by a qualified health care provider operating within the provider's scope of 10
practice for the purpose of diagnosis, treatment, appropriate management, or 11
ongoing monitoring of an insured's disease or condition when the test is 12
supported by medical and scientific evidence, including but not limited to: 13
(a) Labeled indications for an FDA-approved or FDA-cleared test; 14
(b) Indicated tests for an FDA-approved drug; 15
(c) Warnings and precautions on FDA-approved drug labels; 16
(d) Centers for Medicare and Medicaid Services national coverage 17
determinations; 18
(e) Medicare Administrative Contractor local coverage determinations; 19
(f) Nationally recognized clinical practice guidelines; or 20
(g) Consensus statements. 21
(3) The coverage required under this section shall be provided in a manner that 22
limits disruptions in care, including the need for multiple biopsies or biospecimen 23
samples. 24
(4) When coverage for biomarker testing is restricted by an insurer or a third party 25
acting on behalf of the insurer, the insured and prescribing practitioner shall 26
have access to a clear, readily accessible, and convenient process on the insurer's 27 UNOFFICIAL COPY 23 RS BR 229
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website to request an exception to the coverage policy. 1
(5) Any prior authorization requirement applicable to coverage required under this 2
section shall comply with any existing prior authorization laws, including but not 3
limited to KRS 304.17A-607. 4
(6) Nothing in this section shall be construed to: 5
(a) Require coverage of biomarker testing for screening purposes; or 6
(b) Limit coverage required under: 7
1. KRS 304.17A-259; 8
2. Section 2 of this Act; or 9
3. Any other law. 10
Section 2. KRS 205.522 is amended to read as follows: 11
(1) The Department for Medicaid Services and any managed care organization 12
contracted to provide Medicaid benefits pursuant to this chapter shall comply with 13
the provisions of Section 1 of this Act and KRS 304.17A-163, 304.17A-1631, 14
304.17A-167, 304.17A-235, 304.17A-257, 304.17A-259, 304.17A-515, 304.17A-15
580, 304.17A-600, 304.17A-603, 304.17A-607, and 304.17A-740 to 304.17A-743, 16
as applicable. 17
(2) A managed care organization contracted to provide Medicaid benefits pursuant to 18
this chapter shall comply with the reporting requirements of KRS 304.17A-732. 19
Section 3. This Act shall apply to health benefit plans issued, delivered, 20
amended, or renewed on or after January 1, 2024. 21
Section 4. This Act takes effect January 1, 2024. 22