88R7022 RDS-F
 
  By: Bonnen H.B. No. 3188
 
 
 
A BILL TO BE ENTITLED
 
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)  health benefits provided by or through a church
  benefits board under Subchapter I, Chapter 22, Business
  Organizations Code;
               (8)  the state Medicaid program, including the Medicaid
  managed care program operated under Chapter 533, Government Code;
               (9)  the child health plan program under Chapter 62,
  Health and Safety Code;
               (10)  a regional or local health care program operated
  under Section 75.104, Health and Safety Code;
               (11)  a self-funded health benefit plan sponsored by a
  professional employer organization under Chapter 91, Labor Code;
               (12)  county employee group health benefits provided
  under Chapter 157, Local Government Code; and
               (13)  health and accident coverage provided by a risk
  pool created under Chapter 172, Local Government 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 medical and scientific evidence, including:
               (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;
               (3)  is outcome focused; and
               (4)  predominately addresses the acute 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.