S.B. No. 989
AN ACT
relating to health benefit plan coverage for certain biomarker
testing.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle E, Title 8, Insurance Code, is amended
by adding Chapter 1372 to read as follows:
CHAPTER 1372. COVERAGE FOR BIOMARKER TESTING
Sec. 1372.001. DEFINITIONS. In this chapter:
(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. The term
includes:
(A) gene mutations; and
(B) protein expression.
(2) "Biomarker testing" means the analysis of a
patient's tissue, blood, or other biospecimen for the presence of a
biomarker. The term includes:
(A) single-analyte tests;
(B) multiplex panel tests; and
(C) whole genome sequencing.
(3) "Consensus statements" means statements that:
(A) address specific clinical circumstances
based on the best available evidence for the purpose of optimizing
clinical care outcomes; and
(B) are developed by an independent,
multidisciplinary panel of experts that uses a transparent
methodology and reporting structure and is subject to a conflict of
interest policy.
(4) "Nationally recognized clinical practice
guidelines" means evidence-based clinical practice guidelines
that:
(A) establish a standard of care informed by a
systematic review of evidence and an assessment of the benefits and
costs of alternative care options;
(B) include recommendations intended to optimize
patient care; and
(C) are developed by an independent organization
or medical professional society that uses a transparent methodology
and reporting structure and is subject to a conflict of interest
policy.
Sec. 1372.002. APPLICABILITY OF CHAPTER. (a) This chapter
applies only to a health benefit plan that provides benefits for
medical or surgical expenses incurred as a result of a health
condition, accident, or sickness, including an individual, group,
blanket, or franchise insurance policy or insurance agreement, a
group hospital service contract, or an individual or group evidence
of coverage or similar coverage document that is offered by:
(1) an insurance company;
(2) a group hospital service corporation operating
under Chapter 842;
(3) a health maintenance organization operating under
Chapter 843;
(4) an approved nonprofit health corporation that
holds a certificate of authority under Chapter 844;
(5) a multiple employer welfare arrangement that holds
a certificate of authority under Chapter 846;
(6) a stipulated premium company operating under
Chapter 884;
(7) a fraternal benefit society operating under
Chapter 885;
(8) a Lloyd's plan operating under Chapter 941; or
(9) an exchange operating under Chapter 942.
(b) Notwithstanding any other law, this chapter applies to:
(1) a small employer health benefit plan subject to
Chapter 1501, including coverage provided through a health group
cooperative under Subchapter B of that chapter;
(2) a standard health benefit plan issued under
Chapter 1507;
(3) a basic coverage plan under Chapter 1551;
(4) a basic plan under Chapter 1575;
(5) a primary care coverage plan under Chapter 1579;
(6) a plan providing basic coverage under Chapter
1601;
(7) the state Medicaid program, including the Medicaid
managed care program operated under Chapter 533, Government Code;
(8) the child health plan program under Chapter 62,
Health and Safety Code; and
(9) a self-funded health benefit plan sponsored by a
professional employer organization under Chapter 91, Labor Code.
Sec. 1372.003. COVERAGE REQUIRED. (a) Subject to
Subsection (b), a health benefit plan must provide coverage for
biomarker testing for the purpose of diagnosis, treatment,
appropriate management, or ongoing monitoring of an enrollee's
disease or condition to guide treatment when the test is supported
by the following kinds of medical and scientific evidence:
(1) a labeled indication for a test approved or
cleared by the United States Food and Drug Administration;
(2) an indicated test for a drug approved by the United
States Food and Drug Administration;
(3) a national coverage determination made by the
Centers for Medicare and Medicaid Services or a local coverage
determination made by a Medicare administrative contractor;
(4) nationally recognized clinical practice
guidelines; or
(5) consensus statements.
(b) A health benefit plan issuer must provide coverage under
Subsection (a) only when use of biomarker testing provides clinical
utility because use of the test for the condition:
(1) is evidence-based;
(2) is scientifically valid based on the medical and
scientific evidence described by Subsection (a);
(3) informs a patient's outcome and a provider's
clinical decision; and
(4) predominately addresses the acute or chronic issue
for which the test is being ordered, except that a test may include
some information that cannot be immediately used in the formulation
of a clinical decision.
(c) A health benefit plan must provide coverage under
Subsection (a) in a manner that limits disruptions in care,
including limiting the number of biopsies and biospecimen samples.
SECTION 2. If before implementing any provision of this Act
a state agency determines that a waiver or authorization from a
federal agency is necessary for implementation of that provision,
the agency affected by the provision shall request the waiver or
authorization and may delay implementing that provision until the
waiver or authorization is granted.
SECTION 3. The change in law made by this Act applies only
to a health benefit plan that is delivered, issued for delivery, or
renewed on or after January 1, 2024.
SECTION 4. This Act takes effect September 1, 2023.
______________________________ ______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 989 passed the Senate on
April 12, 2023, by the following vote: Yeas 26, Nays 4.
______________________________
Secretary of the Senate
I hereby certify that S.B. No. 989 passed the House on
May 16, 2023, by the following vote: Yeas 114, Nays 24, two
present not voting.
______________________________
Chief Clerk of the House
Approved:
______________________________
Date
______________________________
Governor