Bill Summary – FastDemocracy

WEST VIRGINIA LEGISLATURE
       2024 REGULAR SESSION
                 ENGROSSED
          Committee Substitute for House Bill 4753
    By Delegates Westfall, Barnhart, Riley, Young,
  Hornbuckle, W. Hall, Garcia, Jeffries, Hott, Cannon,
                      and Akers [Originating in the Committee on the Judiciary;
           Reported on February 21, 2024]
    Eng CS for HB 4753
 A BILL to amend the code of West Virginia, 1931, by adding thereto a new section designated, §5-
        16-7h; to amend said code by adding thereto a new section designated §9-5-34; to amend
        said code by adding thereto a new section designated §33-15-4x; to amend said code by
        adding thereto a new section designated §33-16-3aa; to amend said code by adding
        thereto a new section designated §33-24-7y; to amend said code by adding thereto a new
        section designated §33-25-8v; and to amend said code by adding thereto a new section
        designated §33-25A-8y, all relating to providing health insurance coverage concerning
        biomarker testing.
    Be it enacted by the Legislature of West Virginia:
           CHAPTER 5. GENERAL POWERS AND AUTHORITY OF THE
       GOVERNOR, SECRETARY OF STATE AND ATTORNEY GENERAL;
           BOARD OF PUBLIC WORKS; MISCELLANEOUS AGENCIES,
                       COMMISSIONS, OFFICES, PROGRAMS, ETC.
    ARTICLE      16.    WEST      VIRGINIA      PUBLIC      EMPLOYEES        INSURANCE        ACT.
    §5-16-7h.                                   Biomarker testing.
        (a) As used in this section:
        (1) "Biomarker": means a characteristic that is objectively measured and evaluated as an
 indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a
 specific therapeutic intervention, including known gene-drug interactions for medications being
 considered for use or already being administered; and includes but is not limited to gene
 mutations, characteristics of genes and protein expression;
        (2) "Biomarker testing": means the analysis of a patient's tissue, blood, or other
 biospecimen for the presence of a biomarker; and includes but is not limited to single-analyte
                                                1   1
     Eng CS for HB 4753
  tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole
 transcriptome sequencing;
         (3) "Consensus statements" means statements that are:
         (A) Developed by an independent, multidisciplinary panel of experts utilizing a transparent
 methodology and reporting structure with a conflict of interest policy;
         (B) Aimed at specific clinical circumstances; and
         (C) Based on the best available evidence for the purpose of optimizing the outcomes of
 clinical care;
         (4) "FDA" means the United States Food and Drug Administration; and
         (5) "Nationally recognized clinical practice guidelines" means evidence-based clinical
 practice guidelines that:
         (A) Are developed by an independent organization or medical professional society utilizing
 a transparent methodology and reporting structure with a conflict of interest policy and include
 recommendations intended to optimize care;
         (B) Establish standards of care informed by:
         (i) A systematic review of evidence; and
         (ii) An assessment of the benefits and risks of alternative care options.
         (6) "Precision diagnosis" means the use of biomarker testing after a covered individual has
 received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
         (7) "Prior authorization" means obtaining advanced approval from a health insurer about
 the coverage of a service or medication.
         (b)(1) The Public Employees Insurance Agency shall provide coverage for biomarker
 testing for the purposes of precision diagnosis, treatment, appropriate management, or ongoing
 monitoring of a covered person's disease or condition when supported by medical and scientific
 evidence, including, but not limited to:
         (A) Labeled indications for a test approved or cleared by the FDA;
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     Eng CS for HB 4753
        (B) Indicated tests for an FDA-approved drug;
        (C) Warnings and precautions on FDA-approved drug labels;
        (D) Centers for Medicare and Medicaid Services national coverage determinations and
 Medicare administrative contractor local coverage determinations; or
        (E) Nationally recognized clinical practice guidelines such as, but not limited to, those of
 the National Comprehensive Cancer Network or the American Society of Clinical Oncology, and
 consensus statements: Provided, That any treatment provided in accordance with such practice
 guidelines is limited to the use of drugs and tests approved or cleared by the FDA.
        (2) Nothing in this section shall require coverage of biomarker testing for the purpose of
 screening an individual prior to receiving a diagnosis of a disease or condition for which biomarker
 testing is appropriate.
        (3) The coverage shall be provided in a manner that shall limit disruptions in care including
 the need for multiple biopsies or biospecimen samples.
        (4) The Public Employees Insurance Agency may require that biomarker testing be subject
 to prior authorization in accordance with §33-16-3dd.
        (5) The covered person and prescribing practitioner shall have access to a clear, readily
 accessible, and convenient process to request an exception to a coverage policy provided
 pursuant to the provisions of this section. The process shall be made readily accessible on the
 website of the insurer.
        (c) One year following implementation, the Public Employees Insurance Agency shall
 report to the Joint Committee on Government and Finance the cost of this change.
                               CHAPTER 9. HUMAN SERVICES.
     ARTICLE                    5.                MISCELLANEOUS                         PROVISIONS.
     §9-5-34.                                    Biomarker testing.
         (a) As used in this section:
                                                 1    3
     Eng CS for HB 4753
          (1) "Biomarker": means a characteristic that is objectively measured and evaluated as an
  indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a
  specific therapeutic intervention, including known gene-drug interactions for medications being
  considered for use or already being administered; and includes but is not limited to gene
  mutations, characteristics of genes and protein expression;
          (2) "Biomarker testing": means the analysis of a patient's tissue, blood, or other
  biospecimen for the presence of a biomarker; and includes but is not limited to single-analyte
  tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole
 transcriptome sequencing;
         (3) "Consensus statements" means statements that are:
         (A) Developed by an independent, multidisciplinary panel of experts utilizing a transparent
 methodology and reporting structure with a conflict of interest policy;
         (B) Aimed at specific clinical circumstances; and
         (C) Based on the best available evidence for the purpose of optimizing the outcomes of
 clinical care;
         (4) "FDA" means the United States Food and Drug Administration; and
         (5) "Nationally recognized clinical practice guidelines" means evidence-based clinical
 practice guidelines that:
         (A) Are developed by an independent organization or medical professional society utilizing
 a transparent methodology and reporting structure with a conflict of interest policy and include
 recommendations intended to optimize care;
         (B) Establish standards of care informed by:
         (i) A systematic review of evidence; and
         (ii) An assessment of the benefits and risks of alternative care options.
         (6) "Precision diagnosis" means the use of biomarker testing after a covered individual has
 received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
                                                  1     4
     Eng CS for HB 4753
         (7) "Prior authorization" means obtaining advanced approval from a health insurer about
 the coverage of a service or medication.
         (b)(1) The Bureau for Medical Services shall provide coverage for biomarker testing for the
 purposes of precision diagnosis, treatment, appropriate management, or ongoing monitoring of a
 covered person's disease or condition when supported by medical and scientific evidence,
 including, but not limited to:
         (A) Labeled indications for a test approved or cleared by the FDA;
         (B) Indicated tests for an FDA-approved drug;
         (C) Warnings and precautions on FDA-approved drug labels;
         (D) Centers for Medicare and Medicaid Services national coverage determinations and
 Medicare administrative contractor local coverage determinations; or
         (E) Nationally recognized clinical practice guidelines such as, but not limited to, those of
 the National Comprehensive Cancer Network or the American Society of Clinical Oncology, and
 consensus statements: Provided, That any treatment provided in accordance with such practice
 guidelines is limited to the use of drugs and tests approved or cleared by the FDA.
         (2) Nothing in this section shall require coverage of biomarker testing for the purpose of
 screening an individual prior to receiving a diagnosis of a disease or condition for which biomarker
 testing is appropriate.
         (3) The coverage shall be provided in a manner that shall limit disruptions in care including
 the need for multiple biopsies or biospecimen samples.
         (4) The Bureau of Medical Services may require that biomarker testing be subject to prior
 authorization in accordance with §33-16-3dd.
         (5) The covered person and prescribing practitioner shall have access to a clear, readily
 accessible, and convenient process to request an exception to a coverage policy provided
 pursuant to the provisions of this section. The process shall be made readily accessible on the
 website of the insurer.
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     Eng CS for HB 4753
         (c) One year following implementation, the Bureau of Medical Services shall report to the
 Joint Committee on   Government and Finance the cost of   this change.
                                    CHAPTER 33. INSURANCE.
     ARTICLE            15.        ACCIDENT             AND         SICKNESS               INSURANCE.
     §33-15-4x.                                   Biomarker testing.
          (a) As used in this section:
          (1) "Biomarker": means a characteristic that is objectively measured and evaluated as an
  indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a
  specific therapeutic intervention, including known gene-drug interactions for medications being
  considered for use or already being administered; and includes but is not limited to gene
  mutations, characteristics of genes and protein expression;
          (2) "Biomarker testing": means the analysis of a patient's tissue, blood, or other
  biospecimen for the presence of a biomarker; and includes but is not limited to single-analyte
  tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole
 transcriptome sequencing;
         (3) "Consensus statements" means statements that are:
         (A) Developed by an independent, multidisciplinary panel of experts utilizing a transparent
 methodology and reporting structure with a conflict of interest policy;
         (B) Aimed at specific clinical circumstances; and
         (C) Based on the best available evidence for the purpose of optimizing the outcomes of
 clinical care;
         (4) "FDA" means the United States Food and Drug Administration; and
         (5) "Nationally recognized clinical practice guidelines" means evidence-based clinical
 practice guidelines that:
                                                  1   6
     Eng CS for HB 4753
         (A) Are developed by an independent organization or medical professional society utilizing
 a transparent methodology and reporting structure with a conflict of interest policy and include
 recommendations intended to optimize care;
         (B) Establish standards of care informed by:
         (i) A systematic review of evidence; and
         (ii) An assessment of the benefits and risks of alternative care options.
         (6) "Precision diagnosis" means the use of biomarker testing after a covered individual has
 received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
         (7) "Prior authorization" means obtaining advanced approval from a health insurer about
 the coverage of a service or medication.
         (b)(1) The health insurers shall provide coverage for biomarker testing for the purposes of
 precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered
 person's disease or condition when supported by medical and scientific evidence, including, but
 not limited to:
         (A) Labeled indications for a test approved or cleared by the FDA;
         (B) Indicated tests for an FDA-approved drug;
         (C) Warnings and precautions on FDA-approved drug labels;
         (D) Centers for Medicare and Medicaid Services national coverage determinations and
 Medicare administrative contractor local coverage determinations; or
         (E) Nationally recognized clinical practice guidelines such as, but not limited to, those of
 the National Comprehensive Cancer Network or the American Society of Clinical Oncology, and
 consensus statements: Provided, That any treatment provided in accordance with such practice
 guidelines is limited to the use of drugs and tests approved or cleared by the FDA.
         (2) Nothing in this section shall require coverage of biomarker testing for the purpose of
 screening an individual prior to receiving a diagnosis of a disease or condition for which biomarker
 testing is appropriate.
                                                  1     7
     Eng CS for HB 4753
         (3) The coverage shall be provided in a manner that shall limit disruptions in care including
 the need for multiple biopsies or biospecimen samples.
         (4) The health insurers may require that biomarker testing be subject to prior authorization
 in accordance with §33-16-3dd.
         (5) The covered person and prescribing practitioner shall have access to a clear, readily
 accessible, and convenient process to request an exception to a coverage policy provided
 pursuant to the provisions of this section. The process shall be made readily accessible on the
 website of                          the insurer.
     ARTICLE          16.    GROUP           ACCIDENT        AND          SICKNESS       INSURANCE.
     §33-16-3aa.                                      Biomarker testing.
          (a) As used in this section:
          (1) "Biomarker": means a characteristic that is objectively measured and evaluated as an
  indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a
  specific therapeutic intervention, including known gene-drug interactions for medications being
  considered for use or already being administered; and includes but is not limited to gene
  mutations, characteristics of genes and protein expression;
          (2) "Biomarker testing": means the analysis of a patient's tissue, blood, or other
  biospecimen for the presence of a biomarker; and includes but is not limited to single-analyte
  tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole
 transcriptome sequencing;
         (3) "Consensus statements" means statements that are:
         (A) Developed by an independent, multidisciplinary panel of experts utilizing a transparent
 methodology and reporting structure with a conflict of interest policy;
         (B) Aimed at specific clinical circumstances; and
         (C) Based on the best available evidence for the purpose of optimizing the outcomes of
 clinical care;
                                                  1     8
     Eng CS for HB 4753
         (4) "FDA" means the United States Food and Drug Administration; and
         (5) "Nationally recognized clinical practice guidelines" means evidence-based clinical
 practice guidelines that:
         (A) Are developed by an independent organization or medical professional society utilizing
 a transparent methodology and reporting structure with a conflict of interest policy and include
 recommendations intended to optimize care;
         (B) Establish standards of care informed by:
         (i) A systematic review of evidence; and
         (ii) An assessment of the benefits and risks of alternative care options.
         (6) "Precision diagnosis" means the use of biomarker testing after a covered individual has
 received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
         (7) "Prior authorization" means obtaining advanced approval from a health insurer about
 the coverage of a service or medication.
         (b)(1) The health insurers shall provide coverage for biomarker testing for the purposes of
 precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered
 person's disease or condition when supported by medical and