Bill Summary – FastDemocracy

S-0327.1
                               SENATE BILL 5074
     State of Washington       68th Legislature       2023 Regular Session
     By Senators L. Wilson, Cleveland, Braun, Dozier, Fortunato, Van De
     Wege, and Warnick
     Prefiled 12/20/22. Read first time 01/09/23.    Referred to Committee
     on Health & Long Term Care.
      AN ACT Relating to coverage for biomarker testing; adding a new
  section to chapter 48.43 RCW; adding a new section to chapter 41.05
  RCW; and adding a new section to chapter 74.09 RCW.
  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
     NEW SECTION.   Sec. 1.   A new section is added to chapter 48.43
 RCW to read as follows:
     (1) For health plans issued or renewed on or after January 1,
 2024, a health carrier shall include coverage for biomarker testing
 pursuant to the criteria established under subsection (2) of this
 section.
     (2) Biomarker testing must be covered for the purposes of
 diagnosis, treatment, appropriate management, or ongoing monitoring
 of an enrollee's disease or condition when the test is supported by
 medical and scientific evidence including, but not limited to:
     (a) Labeled indications for tests approved or cleared by the
 United States food and drug administration or indicated tests for a
 drug approved by the United States food and drug administration;
     (b) Centers for medicare and medicaid services national coverage
 determinations or medicare administrative contractor local coverage
 determinations;
     (c) Nationally recognized clinical practice guidelines; or
                                     p. 1                           SB 5074
     (d) Consensus statements.
     (3) Health carriers shall ensure coverage as required in
 subsection (2) of this section is provided in a manner that limits
 disruptions in care including the need for multiple biopsies or
 biospecimen samples.
     (4) For the purposes of this section:
     (a) "Biomarker" means a characteristic that is objectively
 measured and evaluated as an indicator of normal biological
 processes, pathogenic processes, or pharmacologic responses to a
 specific therapeutic intervention. Biomarkers include but are not
 limited to gene mutations or protein expression.
     (b) "Biomarker testing" means the analysis of a patient's tissue,
 blood, or other biospecimen for the presence of a biomarker.
 Biomarker testing includes but is not limited to single-analyte
 tests, multiplex panel tests, and whole genome sequencing.
     (c) "Consensus statements" means statements that are:
     (i) Developed by an independent, multidisciplinary panel of
 experts utilizing a transparent methodology and reporting structure
 and with a conflict of interest policy;
     (ii) Aimed at specific clinical circumstances; and
     (iii) Based on the best available evidence for the purpose of
 optimizing the outcomes of clinical care.
     (d) "Nationally recognized clinical practice guidelines" means
 evidence-based clinical practice guidelines that:
     (i) Are developed by independent organizations or medical
 professional societies utilizing a transparent methodology and
 reporting structure and with a conflict of interest policy;
     (ii) Establish standards of care informed by a systematic review
 of evidence and an assessment of the benefits and costs of
 alternative care options; and
     (iii) Include recommendations intended to optimize patient care.
     NEW SECTION.   Sec. 2.   A new section is added to chapter 41.05
 RCW to read as follows:
     (1) A health plan offered to public employees and their covered
 dependents under this chapter issued or renewed on or after January
 1, 2024, shall include coverage for biomarker testing pursuant to the
 criteria established under subsection (2) of this section.
     (2) Biomarker testing must be covered for the purposes of
 diagnosis, treatment, appropriate management, or ongoing monitoring
                                     p. 2                          SB 5074
 of an enrollee's disease or condition when the test is supported by
 medical and scientific evidence including, but not limited to:
     (a) Labeled indications for tests approved or cleared by the
 United States food and drug administration or indicated tests for a
 drug approved by the United States food and drug administration;
     (b) Centers for medicare and medicaid services national coverage
 determinations or medicare administrative contractor local coverage
 determinations;
     (c) Nationally recognized clinical practice guidelines; or
     (d) Consensus statements.
     (3) A health plan offered to public employees and their covered
 dependents shall ensure coverage as required in subsection (2) of
 this section is provided in a manner that limits disruptions in care
 including the need for multiple biopsies or biospecimen samples.
     (4) For the purposes of this section:
     (a) "Biomarker" means a characteristic that is objectively
 measured and evaluated as an indicator of normal biological
 processes, pathogenic processes, or pharmacologic responses to a
 specific therapeutic intervention. Biomarkers include but are not
 limited to gene mutations or protein expression.
     (b) "Biomarker testing" means the analysis of a patient's tissue,
 blood, or other biospecimen for the presence of a biomarker.
 Biomarker testing includes but is not limited to single-analyte
 tests, multiplex panel tests, and whole genome sequencing.
     (c) "Consensus statements" means statements that are:
     (i) Developed by an independent, multidisciplinary panel of
 experts utilizing a transparent methodology and reporting structure
 and with a conflict of interest policy;
     (ii) Aimed at specific clinical circumstances; and
     (iii) Based on the best available evidence for the purpose of
 optimizing the outcomes of clinical care.
     (d) "Nationally recognized clinical practice guidelines" means
 evidence-based clinical practice guidelines that:
     (i) Are developed by independent organizations or medical
 professional societies utilizing a transparent methodology and
 reporting structure and with a conflict of interest policy;
     (ii) Establish standards of care informed by a systematic review
 of evidence and an assessment of the benefits and costs of
 alternative care options; and
     (iii) Include recommendations intended to optimize patient care.
                                     p. 3                          SB 5074
     NEW SECTION.   Sec. 3.   A new section is added to chapter 74.09
 RCW to read as follows:
     (1) Beginning January 1, 2024, the authority shall provide
 coverage under this chapter for biomarker testing pursuant to the
 criteria established under subsection (2) of this section.
     (2) Biomarker testing must be covered for the purposes of
 diagnosis, treatment, appropriate management, or ongoing monitoring
 of an enrollee's disease or condition when the test is supported by
 medical and scientific evidence including, but not limited to:
     (a) Labeled indications for tests approved or cleared by the
 United States food and drug administration or indicated tests for a
 drug approved by the United States food and drug administration;
     (b) Centers for medicare and medicaid services national coverage
 determinations or medicare administrative contractor local coverage
 determinations;
     (c) Nationally recognized clinical practice guidelines; or
     (d) Consensus statements.
     (3) The authority shall ensure coverage as required in subsection
 (2) of this section is provided in a manner that limits disruptions
 in care including the need for multiple biopsies or biospecimen
 samples.
     (4) In administering this program, the authority shall seek any
 available   federal   financial  participation   under    the  medical
 assistance program, as codified at Title XIX of the federal social
 security act, or any other federal funding sources that are now
 available or may become available.
     (5) For the purposes of this section:
     (a) "Biomarker" means a characteristic that is objectively
 measured and evaluated as an indicator of normal biological
 processes, pathogenic processes, or pharmacologic responses to a
 specific therapeutic intervention. Biomarkers include but are not
 limited to gene mutations or protein expression.
     (b) "Biomarker testing" means the analysis of a patient's tissue,
 blood, or other biospecimen for the presence of a biomarker.
 Biomarker testing includes but is not limited to single-analyte
 tests, multiplex panel tests, and whole genome sequencing.
     (c) "Consensus statements" means statements that are:
     (i) Developed by an independent, multidisciplinary panel of
 experts utilizing a transparent methodology and reporting structure
 and with a conflict of interest policy;
                                     p. 4                          SB 5074
     (ii) Aimed at specific clinical circumstances; and
     (iii) Based on the best available evidence for the purpose of
 optimizing the outcomes of clinical care.
     (d) "Nationally recognized clinical practice guidelines" means
 evidence-based clinical practice guidelines that:
     (i) Are developed by independent organizations or medical
 professional societies utilizing a transparent methodology and
 reporting structure and with a conflict of interest policy;
     (ii) Establish standards of care informed by a systematic review
 of evidence and an assessment of the benefits and costs of
 alternative care options; and
     (iii) Include recommendations intended to optimize patient care.
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