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WEST virginia legislature
2024 regular session
Introduced
House Bill 4753
By Delegates Westfall, Barnhart, Riley, Hornbuckle, W. Hall, Garcia, Jeffries, Hott, Cannon, Akers and Young
[Introduced January 15, 2024; Referred
to the Committee Banking and Insurance then Judiciary ]
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:
(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.
(b) (1) The Public Employees Insurance Agency shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) Indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The Bureau for Medical Services shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The health insurers shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The health insurers shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The health insurers shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The health insurers shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
(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:
(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.
(b) (1) The health insurers shall provide coverage for biomarker testing for the purposes of 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 federal food and drug administration;
(B) indicated tests for a food and drug administration 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.
(2) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(3) 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.
NOTE: The purpose of this bill is to require insurance coverage for biomarker testing.
Strike-throughs indicate language that would be stricken from a heading or the present law and underscoring indicates new language that would be added.
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