HB4753 HFA Garcia 2-26
Delegate Garcia moves to amend Com Sub for HB4753 on page one, following the enacting clause, by striking out the remainder of the bill and inserting in lieu thereof, the following:
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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.
(2) Nothing in this section shall require coverage of biomarker testing for the purpose of screening an individual prior to initiating diagnostic testing or care for 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) Biomarker testing may be subject to prior authorization in accordance with §33-16-3dd of this code..
(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.
(6) Biomarker testing shall be covered subject to the availability of federal matching funds.
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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
(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) Biomarker testing may 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.
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate. (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 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 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) Nothing in this section shall require coverage of biomarker testing for the purpose of screening an individual prior to initiating diagnostic testing or care receiving a diagnosis for a disease or condition for which biomarker testing is appropriate.
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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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.
(2) Nothing in this section shall require coverage of biomarker testing for the purpose of screening an individual prior to initiating diagnostic testing or care for 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) Biomarker testing may 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.
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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.
(2) Nothing in this section shall require coverage of biomarker testing for the purpose of screening an individual prior to initiating diagnostic testing or care for 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) Biomarker testing may 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.
(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) “Precision diagnosis" means the use of biomarker testing to confirm a suspected disease or condition or after a covered individual has received a medical diagnosis of a disease or condition for which biomarker testing is appropriate.
(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 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 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.
(2) Nothing in this section shall require coverage of biomarker testing for the purpose of screening an individual prior to initiating diagnostic testing or care for 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) Biomarker testing may be subject to prior authorization in accordance with §33-16-3dd of this code.
(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."