H-2977.2
SECOND SUBSTITUTE HOUSE BILL 1450
State of Washington 68th Legislature 2024 Regular Session
By House Health Care & Wellness (originally sponsored by
Representatives Stonier, Harris, Simmons, Reed, and Macri)
READ FIRST TIME 01/31/24.
1 AN ACT Relating to coverage for biomarker testing; adding a new
2 section to chapter 48.43 RCW; adding a new section to chapter 41.05
3 RCW; and adding a new section to chapter 74.09 RCW.
4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
5 NEW SECTION. Sec. 1. A new section is added to chapter 48.43
6 RCW to read as follows:
7 (1) For health plans issued or renewed on or after January 1,
8 2025, a health carrier shall include coverage for biomarker testing
9 pursuant to the criteria established under subsection (2) of this
10 section.
11 (2) Biomarker testing must be covered for the purposes of
12 diagnosis, treatment, appropriate management, or ongoing monitoring
13 of an enrollee's disease or condition when the test is supported by
14 medical and scientific evidence including, but not limited to:
15 (a) Labeled indications for tests approved or cleared by the
16 United States food and drug administration or indicated tests for a
17 drug approved by the United States food and drug administration;
18 (b) Centers for medicare and medicaid services national coverage
19 determinations or medicare administrative contractor local coverage
20 determinations; or
21 (c) Nationally recognized clinical practice guidelines.
p. 1 2SHB 1450
 1 (3) Health carriers shall ensure coverage as required in
2 subsection (2) of this section is provided in a manner that limits
3 the need for multiple biopsies or biospecimen samples.
4 (4) Biomarker screening tests and biomarker testing that is
5 investigatory in nature are not required to be covered under this
6 section.
7 (5) To the extent allowed under this chapter and not prohibited
8 under this section, health plans may apply prior authorization and
9 utilization management strategies to biomarker testing.
10 (6) For the purposes of this section:
11 (a) "Biomarker" means a characteristic that is objectively
12 measured and evaluated as an indicator of normal biological
13 processes, pathogenic processes, or pharmacologic responses to a
14 specific therapeutic intervention. Biomarkers include but are not
15 limited to gene mutations or protein expression.
16 (b) "Biomarker testing" means the analysis of a patient's tissue,
17 blood, or other biospecimen for the presence of a biomarker.
18 Biomarker testing includes but is not limited to single-analyte
19 tests, multiplex panel tests, and whole genome sequencing.
20 (c) "Nationally recognized clinical practice guidelines" means
21 evidence-based clinical practice guidelines that:
22 (i) Are developed by independent organizations or medical
23 professional societies utilizing a transparent methodology and
24 reporting structure and with a conflict of interest policy;
25 (ii) Establish standards of care informed by a systematic review
26 of evidence and an assessment of the benefits and costs of
27 alternative care options; and
28 (iii) Include recommendations intended to optimize patient care.
29 NEW SECTION. Sec. 2. A new section is added to chapter 41.05
30 RCW to read as follows:
31 (1) A health plan offered to public employees and their covered
32 dependents under this chapter issued or renewed on or after January
33 1, 2025, shall include coverage for biomarker testing pursuant to the
34 criteria established under subsection (2) of this section.
35 (2) Biomarker testing must be covered for the purposes of
36 diagnosis, treatment, appropriate management, or ongoing monitoring
37 of an enrollee's disease or condition when the test is supported by
38 medical and scientific evidence including, but not limited to:
p. 2 2SHB 1450
 1 (a) Labeled indications for tests approved or cleared by the
2 United States food and drug administration or indicated tests for a
3 drug approved by the United States food and drug administration;
4 (b) Centers for medicare and medicaid services national coverage
5 determinations or medicare administrative contractor local coverage
6 determinations; or
7 (c) Nationally recognized clinical practice guidelines.
8 (3) A health plan offered to public employees and their covered
9 dependents shall ensure coverage as required in subsection (2) of
10 this section is provided in a manner that limits the need for
11 multiple biopsies or biospecimen samples.
12 (4) Biomarker screening tests and biomarker testing that is
13 investigatory in nature are not required to be covered under this
14 section.
15 (5) To the extent allowed under this chapter and not prohibited
16 under this section, health plans may apply prior authorization and
17 utilization management strategies to biomarker testing.
18 (6) For the purposes of this section:
19 (a) "Biomarker" means a characteristic that is objectively
20 measured and evaluated as an indicator of normal biological
21 processes, pathogenic processes, or pharmacologic responses to a
22 specific therapeutic intervention. Biomarkers include but are not
23 limited to gene mutations or protein expression.
24 (b) "Biomarker testing" means the analysis of a patient's tissue,
25 blood, or other biospecimen for the presence of a biomarker.
26 Biomarker testing includes but is not limited to single-analyte
27 tests, multiplex panel tests, and whole genome sequencing.
28 (c) "Nationally recognized clinical practice guidelines" means
29 evidence-based clinical practice guidelines that:
30 (i) Are developed by independent organizations or medical
31 professional societies utilizing a transparent methodology and
32 reporting structure and with a conflict of interest policy;
33 (ii) Establish standards of care informed by a systematic review
34 of evidence and an assessment of the benefits and costs of
35 alternative care options; and
36 (iii) Include recommendations intended to optimize patient care.
37 NEW SECTION. Sec. 3. A new section is added to chapter 74.09
38 RCW to read as follows:
p. 3 2SHB 1450
 1 (1) Beginning January 1, 2025, the authority shall provide
2 coverage under this chapter for biomarker testing pursuant to the
3 criteria established under subsection (2) of this section.
4 (2) Biomarker testing must be covered for the purposes of
5 diagnosis, treatment, appropriate management, or ongoing monitoring
6 of an enrollee's disease or condition when the test is supported by
7 medical and scientific evidence including, but not limited to:
8 (a) Labeled indications for tests approved or cleared by the
9 United States food and drug administration or indicated tests for a
10 drug approved by the United States food and drug administration;
11 (b) Centers for medicare and medicaid services national coverage
12 determinations or medicare administrative contractor local coverage
13 determinations; or
14 (c) Nationally recognized clinical practice guidelines.
15 (3) The authority shall ensure coverage as required in subsection
16 (2) of this section is provided in a manner that limits the need for
17 multiple biopsies or biospecimen samples.
18 (4) In administering this program, the authority shall seek any
19 available federal financial participation under the medical
20 assistance program, as codified at Title XIX of the federal social
21 security act, or any other federal funding sources that are now
22 available or may become available.
23 (5) Biomarker screening tests and biomarker testing that is
24 investigatory in nature are not required to be covered under this
25 section.
26 (6) To the extent allowed under this chapter and not prohibited
27 under this section, health plans may apply prior authorization and
28 utilization management strategies to biomarker testing.
29 (7) For the purposes of this section:
30 (a) "Biomarker" means a characteristic that is objectively
31 measured and evaluated as an indicator of normal biological
32 processes, pathogenic processes, or pharmacologic responses to a
33 specific therapeutic intervention. Biomarkers include but are not
34 limited to gene mutations or protein expression.
35 (b) "Biomarker testing" means the analysis of a patient's tissue,
36 blood, or other biospecimen for the presence of a biomarker.
37 Biomarker testing includes but is not limited to single-analyte
38 tests, multiplex panel tests, and whole genome sequencing.
39 (c) "Nationally recognized clinical practice guidelines" means
40 evidence-based clinical practice guidelines that:
p. 4 2SHB 1450
1 (i) Are developed by independent organizations or medical
2 professional societies utilizing a transparent methodology and
3 reporting structure and with a conflict of interest policy;
4 (ii) Establish standards of care informed by a systematic review
5 of evidence and an assessment of the benefits and costs of
6 alternative care options; and
7 (iii) Include recommendations intended to optimize patient care.
--- END ---
p. 5 2SHB 1450