Biomarker testing coverage

AN ACT Relating to coverage for biomarker testing; adding a new 1
section to chapter 48.43 RCW; adding a new section to chapter 41.05 2
RCW; and adding a new section to chapter 74.09 RCW.3
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:4
NEW SECTION. Sec. 1. A new section is added to chapter 48.43 5
RCW to read as follows: 6
(1) For health plans issued or renewed on or after January 1, 7
2026, a health carrier shall include coverage for biomarker testing 8
pursuant to the criteria established under subsection (2) of this 9
section. 10
(2) Biomarker testing must be covered for the purposes of 11
diagnosis, treatment, appropriate management, or ongoing monitoring 12
of an enrollee's disease or condition when the test is supported by 13
medical and scientific evidence including, but not limited to:14
(a) Labeled indications for tests approved or cleared by the 15
United States food and drug administration or indicated tests for a 16
drug approved by the United States food and drug administration;17
(b) Centers for medicare and medicaid services national coverage 18
determinations or medicare administrative contractor local coverage 19
determinations; 20
(c) Nationally recognized clinical practice guidelines; or21
H-0187.1
HOUSE BILL 1062
State of Washington 69th Legislature 2025 Regular Session
By Representatives Stonier, Corry, Parshley, Thai, Macri, Ryu,
Leavitt, Berry, Reed, Alvarado, Callan, Tharinger, Fosse, Simmons,
Davis, Ormsby, Reeves, Bernbaum, Donaghy, and Hill
Prefiled 12/13/24. Read first time 01/13/25. Referred to Committee
on Health Care & Wellness.
p. 1 HB 1062
(d) Consensus statements. 1
(3) Health carriers shall ensure coverage as required in 2
subsection (2) of this section is provided in a manner that limits 3
disruptions in care including the need for multiple biopsies or 4
biospecimen samples. 5
(4) For the purposes of this section: 6
(a) "Biomarker" means a characteristic that is objectively 7
measured and evaluated as an indicator of normal biological 8
processes, pathogenic processes, or pharmacologic responses to a 9
specific therapeutic intervention. Biomarkers include but are not 10
limited to gene mutations or protein expression. 11
(b) "Biomarker testing" means the analysis of a patient's tissue, 12
blood, or other biospecimen for the presence of a biomarker. 13
Biomarker testing includes but is not limited to single-analyte 14
tests, multiplex panel tests, and whole genome sequencing.15
(c) "Consensus statements" means statements that are:16
(i) Developed by an independent, multidisciplinary panel of 17
experts utilizing a transparent methodology and reporting structure 18
and with a conflict of interest policy; 19
(ii) Aimed at specific clinical circumstances; and20
(iii) Based on the best available evidence for the purpose of 21
optimizing the outcomes of clinical care. 22
(d) "Nationally recognized clinical practice guidelines" means 23
evidence-based clinical practice guidelines that: 24
(i) Are developed by independent organizations or medical 25
professional societies utilizing a transparent methodology and 26
reporting structure and with a conflict of interest policy;27
(ii) Establish standards of care informed by a systematic review 28
of evidence and an assessment of the benefits and costs of 29
alternative care options; and 30
(iii) Include recommendations intended to optimize patient care.31
NEW SECTION. Sec. 2. A new section is added to chapter 41.05 32
RCW to read as follows: 33
(1) A health plan offered to public employees and their covered 34
dependents under this chapter issued or renewed on or after January 35
1, 2026, shall include coverage for biomarker testing pursuant to the 36
criteria established under subsection (2) of this section.37
(2) Biomarker testing must be covered for the purposes of 38
diagnosis, treatment, appropriate management, or ongoing monitoring 39
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of an enrollee's disease or condition when the test is supported by 1
medical and scientific evidence including, but not limited to:2
(a) Labeled indications for tests approved or cleared by the 3
United States food and drug administration or indicated tests for a 4
drug approved by the United States food and drug administration;5
(b) Centers for medicare and medicaid services national coverage 6
determinations or medicare administrative contractor local coverage 7
determinations; 8
(c) Nationally recognized clinical practice guidelines; or9
(d) Consensus statements. 10
(3) A health plan offered to public employees and their covered 11
dependents shall ensure coverage as required in subsection (2) of 12
this section is provided in a manner that limits disruptions in care 13
including the need for multiple biopsies or biospecimen samples.14
(4) For purposes of this section, "biomarker," "biomarker 15
testing," "consensus statements," and "nationally recognized clinical 16
practice guidelines" all have the same meaning as defined in section 17
1 of this act. 18
NEW SECTION. Sec. 3. A new section is added to chapter 74.09 19
RCW to read as follows: 20
(1) Beginning January 1, 2026, the authority shall provide 21
coverage under this chapter for biomarker testing pursuant to the 22
criteria established under subsection (2) of this section.23
(2) Biomarker testing must be covered for the purposes of 24
diagnosis, treatment, appropriate management, or ongoing monitoring 25
of an enrollee's disease or condition when the test is supported by 26
medical and scientific evidence including, but not limited to:27
(a) Labeled indications for tests approved or cleared by the 28
United States food and drug administration or indicated tests for a 29
drug approved by the United States food and drug administration;30
(b) Centers for medicare and medicaid services national coverage 31
determinations or medicare administrative contractor local coverage 32
determinations; 33
(c) Nationally recognized clinical practice guidelines; or34
(d) Consensus statements. 35
(3) The authority shall ensure coverage as required in subsection 36
(2) of this section is provided in a manner that limits disruptions 37
in care including the need for multiple biopsies or biospecimen 38
samples. 39
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(4) In administering this program, the authority shall seek any 1
available federal financial participation under the medical 2
assistance program, as codified at Title XIX of the federal social 3
security act, or any other federal funding sources that are now 4
available or may become available. 5
(5) For purposes of this section, "biomarker," "biomarker 6
testing," "consensus statements," and "nationally recognized clinical 7
practice guidelines" all have the same meaning as defined in section 8
1 of this act. 9
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