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Legislation Document
SPONSOR:
Sen. Mantzavinos & Rep. Bush
Sens. Cruce, Hansen, Hoffner, Seigfried, Walsh, Wilson; Reps. Berry, Gorman, Morrison
DELAWARE STATE SENATE
153rd GENERAL ASSEMBLY
SENATE BILL NO. 120
AN ACT TO AMEND TITLES 18, 29, AND 31 OF THE DELAWARE CODE RELATING TO HEALTH INSURANCE.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
Section 1. Amend Chapter 33, Title 18 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows and by redesignating accordingly:
§ 3370M. Biomarker testing.
(a) For purposes of this section:
(1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression.
(2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
(3) “Consensus statement” means a statement that describes optimal clinical care outcomes, based on the best available evidence, for a specific clinical circumstance and is developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure and adhering to a conflict-of-interest policy.
(4) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care.
(b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State 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 the test is supported by medical and scientific evidence, including any of the following:
(1) Labeled indications for an FDA-approved or FDA-cleared test.
(2) Indicated tests for an FDA-approved drug.
(3) Warnings and precautions on FDA-approved drug labels.
(4) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations.
(5) Nationally recognized clinical practice guidelines and consensus statements.
(c) Insurers, health-benefit plans, and health-service corporations must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
(d) Nothing in this section prevents the operation of a policy provision required by this section as a deductible, coinsurance, allowable charge limitation, or coordination of benefits.
(e) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies.
Section 2. Amend Chapter 35, Title 18 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows and by redesignating accordingly:
§ 3571EE. Biomarker testing.
(a) For purposes of this section:
(1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression.
(2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
(3) “Consensus statement” means a statement that describes optimal clinical care outcomes, based on the best available evidence, for a specific clinical circumstance and is developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure and adhering to a conflict-of-interest policy.
(4) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care.
(b) All group and blanket health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State 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 the test is supported by medical and scientific evidence, including any of the following:
(1) Labeled indications for an FDA-approved or FDA-cleared test.
(2) Indicated tests for an FDA-approved drug.
(3) Warnings and precautions on FDA-approved drug labels.
(4) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations.
(5) Nationally recognized clinical practice guidelines and consensus statements.
(c) Insurers, health-benefit plans, and health-service corporations must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
(d) Nothing in this section prevents the operation of a policy provision required by this section as a deductible, coinsurance, allowable charge limitation, or coordination of benefits.
(e) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies.
Section 3. Amend Chapter 52, Title 29 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows and by redesignating accordingly:
§ 5223. Biomarker testing.
(a) For purposes of this section:
(1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression.
(2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
(3) “Consensus statement” means a statement that describes optimal clinical care outcomes, based on the best available evidence, for a specific clinical circumstance and is developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure and adhering to a conflict-of-interest policy.
(4) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care.
(b) This plan 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 the test is supported by medical and scientific evidence, including any of the following:
(1) Labeled indications for an FDA-approved or FDA-cleared test.
(2) Indicated tests for an FDA-approved drug.
(3) Warnings and precautions on FDA-approved drug labels.
(4) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations.
(5) Nationally recognized clinical practice guidelines and consensus statements.
(c) Carriers must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
Section 4. Amend Chapter 5, Title 31 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows and by redesignating accordingly:
§ 538. Biomarker testing.
(a) For purposes of this section:
(1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression.
(2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
(3) “Consensus statement” means a statement that describes optimal clinical care outcomes, based on the best available evidence, for a specific clinical circumstance and is developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure and adhering to a conflict-of-interest policy.
(4) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care.
(b) Carriers shall provide, in all health benefit plans delivered or issued for delivery under § 503(3) of this title, coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person’s disease or condition when the test is supported by medical and scientific evidence, including any of the following:
(1) Labeled indications for an FDA-approved or FDA-cleared test.
(2) Indicated tests for an FDA-approved drug.
(3) Warnings and precautions on FDA-approved drug labels.
(4) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations.
(5) Nationally recognized clinical practice guidelines and consensus statements.
(c) Carriers must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
Section 5.
Effective Date. This Act applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2026.
SYNOPSIS
This Act requires that individual, group, State employee, and public assistance insurance plans provide coverage for biomarker testing, when the test is supported by medical and scientific evidence. The Act applies to all such policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2026.
Author: Senator Mantzavinos