Requiring insurance coverage for biomarker testing

SB 464 Text

skip navigation

SENATE

PRESIDENT

SENATORS

COMMITTEES

VIDEO/AUDIO

DISTRICT MAPS

SENATE CLERK

SENATE RULES

HOUSE

SPEAKER

DELEGATES

COMMITTEES

VIDEO/AUDIO

DISTRICT MAPS

HOUSE CLERK

HOUSE RULES

HOUSE STAFF

JOINT

INTERIM COMMITTEES

LEGISLATIVE ADMINISTRATOR

LEGISLATIVE SERVICES DIVISION

PUBLIC INFORMATION

LEGISLATIVE AUTOMATED SYSTEMS DIVISION

LEGISLATIVE AUDITOR'S OFFICE

PERFORMANCE EVALUATION & RESEARCH DIVISION

POST AUDIT DIVISION

BUDGET DIVISION

REGULATORY AND FISCAL AFFAIRS DIVISION

CLAIMS COMMISSION

CRIME VICTIMS

RULE-MAKING REVIEW

SPECIAL INVESTIGATIONS

JUDICIAL COMP. COMMISSION

JOINT RULES

STAFF INFO

BILL STATUS

BILL STATUS

BILL TRACKING

STATE LAW

WEST VIRGINIA CODE

ACTS OF THE LEGISLATURE

CODE OF 1931

WV CONSTITUTION

US CONSTITUTION

REPORTS

AGENCY REPORTS

AGENCY GRANT AWARDS

PERFORMANCE EVALUATIONS

POST AUDITS

EDUCATIONAL

CITIZEN’S GUIDE

INTERNSHIP PROGRAM

PAGE PROGRAM

PUBLICATIONS

PHOTO GALLERY

CAPITOL HISTORY

HOW A BILL BECOMES LAW

CONTACT

SENATE ROSTER

HOUSE ROSTER

PUBLIC INFO.

NEWS RELEASES

HELPFUL LINKS

Introduced Version

Senate Bill 464 History

|
Email

Key:
Green
= existing Code.
Red
= new code to be enacted

WEST virginia legislature
2026 regular session

FISCAL NOTE

Introduced
Senate Bill 464
By Senator Chapman
[Introduced January 16, 2026; referred
to the Committee on Health and Human Resources; and then to the Committee on Finance]
A BILL to amend the Code of West Virginia, 1931, as amended, by adding seven new sections, designated §5-16-7h, §9-5-34, §33-15-4y, §33-16-3ii, §33-24-7z, §33-25-8w, and §33-25A-8z, relating the West Virginia Public Employees Insurance Act, Human Services, and insurance; defining biomarker testing and other specific terms; requiring the coverage of biomarker testing; and requiring reporting.
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:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.
"Consensus statements" means statements that are:
(1) Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict of interest policy;
(2) Aimed at specific clinical circumstances; and
(3) Based on the best available evidence for the purpose of optimizing the outcomes of clinical care;
"FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;
"Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that:
(1) 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;
(2) Establish standards of care informed by:
(A) A systematic review of evidence; and
(B) An assessment of the benefits and risks of alternative care options.
"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. and
"Prior authorization" means obtaining advanced approval from a health insurer about the coverage of a service or medication.
(b) The Public Employees Insurance Agency shall provide coverage for biomarker testing when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated by medical and scientific evidence, including, but not limited to:
(1) Labeled indications for a test approved or cleared by the FDA;
(2) Indicated tests for an FDA-approved drug;
(3) Warnings and precautions on FDA-approved drug labels;
(4) Centers for Medicare and Medicaid Services national coverage determinations and Medicare administrative contractor local coverage determinations; or
(5) 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.
(c) Nothing in this section may 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.
(d) The coverage shall be provided in a manner that shall limit disruptions in care including the need for multiple biopsies or biospecimen samples.
(e) The Public Employees Insurance Agency may require that biomarker testing be subject to prior authorization in accordance with §5-16-7f of this code.
(f) The covered person and treating physician 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
.
(g) 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:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.
"Consensus statements" means statements that are:
(1) Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict of interest policy;
(2) Aimed at specific clinical circumstances; and
(3) Based on the best available evidence for the purpose of optimizing the outcomes of clinical care;
"FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;
"Nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that:
(1) 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;
(2) Establish standards of care informed by:
(A) A systematic review of evidence; and
(B) An assessment of the benefits and risks of alternative care options.
"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; and
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
when ordered by a treating physician operating within the provider's scope of practice
for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when
the test is medically indicated and provides clinical utility
as demonstrated 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 may 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 limits 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 §9-5-32 of this code.
(5) The covered person and treating physician 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 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.

§33-15-4y. Biomarker testing.

(a) As used in this section:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision;
"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;
"FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;
"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.
"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; and
"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 when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated 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 may 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 limits 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 §33-15-4s of this code.
(5) The covered person and treating physician 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.

§33-16-3ii. Biomarker testing.

(a) As used in this section:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision;
"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;
"FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;
"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.
"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; and
"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 when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated by 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 may 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 limits 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 of this code.
(5) The covered person and treating physician 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 24. HOSPITAL SERVICE CORPORATIONS, MEDICAL SERVICE CORPORATIONS, DENTAL SERVICE CORPORATIONS, AND HEALTH SERVICE CORPORATIONS.

§33-24-7z. Biomarker testing.

(a) As used in this section:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision;
"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;
"FDA" means the United States Food and Drug Administration;
(6) "Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;

"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.
"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; and
"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 when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated 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 may 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 limits 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 §33-24-7s of this code.
(5) The covered person and treating physician 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 25. HEALTH CARE CORPORATIONS.

§33-25-8w
. Biomarker testing.

(a) As used in this section:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision;
"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;
"FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;

"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.
"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; and
"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 when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated 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 may 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 limits 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 treating physician 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 25A. HEALTH MAINTENANCE ORGANIZATION ACT.

§33-25A-8z. Biomarker testing.

(a) As used in this section:
"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;
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen performed at a participating in-network laboratory facility that is either CLIA certified or CLIA waived by the Federal Food and Drug Administration 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;
"Clinical utility" means a test result to provide information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision;
(4) "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;
(6) "FDA" means the United States Food and Drug Administration;
"Medically indicated" means a patient’s treating physician determines the biomarker test is necessary based upon the individual’s specific medical condition and nationally recognized clinical practice guidelines;

"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.
"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; and
"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 when ordered by a treating physician operating within the provider's scope of practice for the purposes of diagnosis, precision diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is medically indicated and provides clinical utility as demonstrated 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 may 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 limits 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 §33-25A-8s of this code.
(5) The covered person and treating physician 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.

Bill Status
|

Bill Tracking
|

Legacy WV Code
|

Bulletin Board
|

District Maps
|

Senate Roster
|

House Roster
|

Live
|

Blog
|

Jobs
|

Links
|

Home

This Web site is maintained by the
West Virginia Legislature's Office of Reference & Information.
|
Terms of Use
|

Webmaster
| © 2026 West Virginia Legislature **

Print On Demand

Name:

Email:

Phone: