SENATE BILL REPORT
SB 5822
As of January 26, 2022
Title: An act relating to insurance coverage for biomarker testing.
Brief Description: Concerning insurance coverage for biomarker testing.
Sponsors: Senators Wilson, L., Brown, Dozier, Frockt, Hasegawa, Stanford and Warnick.
Brief History:
Committee Activity: Health & Long Term Care: 1/28/22.
Brief Summary of Bill
  • Requires insurance coverage for biomarker testing when supported by medical and scientific evidence.
SENATE COMMITTEE ON HEALTH & LONG TERM CARE
Staff: Greg Attanasio (786-7410)
Background:

The United States Food and Drug Administration (FDA) defines a biomarker as a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.  According to the National Institutes of Health, a biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease, which may be used to see how well the body responds to a treatment for a disease or condition.  Biomarker testing has been used in a number of clinical applications, including screening and diagnostic tests, treatment and post-treatment monitoring, prognostic tests for estimating risk or time to clinical outcomes, and to predict patient response to specific treatments. 
Summary of Bill:

Beginning January 1, 2023,  health carriers, nonprofit health benefit plans, and health maintenance organizations must provide coverage for biomarker testing for the diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the test is supported by medical and scientific evidence, including:

  • labeled indications for tests approved by the FDA or indicated tests for a drug approved by the FDA;
  • Centers for Medicare and Medicaid Services national coverage determinations; or
  • nationally recognized clinical practice guidelines.

 

Carriers must ensure coverage is provided in a manner that limits disruptions in care, including limiting the need for multiple biopsies or biospecimen samples. 

 

"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.  Biomarkers include, but are not limited to, gene mutations or protein expression.

 

"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes, but is not limited to, single-analyte tests, multiplex panel tests, and whole genome sequencing.
Appropriation: None.
Fiscal Note: Requested on January 25, 2022.
Creates Committee/Commission/Task Force that includes Legislative members: No.
Effective Date: Ninety days after adjournment of session in which bill is passed.