SENATE BILL 435
By Reeves
HOUSE BILL 484
By Martin B
HB0484
001522
- 1 -
AN ACT to amend Tennessee Code Annotated, Title 56
and Title 71, relative to coverage of biomarker
testing.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 56, Chapter 7, Part 23, is amended by
adding the following as a new section:
(a) As used in this section:
(1) "Biomarker":
(A) 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; and
(B) Includes gene mutations, characteristics of genes, and protein
expression;
(2) "Biomarker testing":
(A) Means the analysis of a patient's tissue, blood, or other
biospecimen for the presence of a biomarker; and
(B) 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 developed by an
independent, multidisciplinary panel of experts utilizing a transparent
- 2 - 001522
methodology and reporting structure that includes a conflict of interest policy, that
is aimed at specific clinical circumstances, and that bases the statement on the
best available evidence for the purpose of optimizing the outcomes of clinical
care;
(4) "Health benefit plan" means health insurance coverage as defined in
§ 56-7-109;
(5) "Health insurer" means a health insurance entity as defined in § 56-7-
109; and
(6) "Nationally recognized clinical practice guideline" means an evidence-
based clinical practice guideline developed by an independent organization or
professional medical society utilizing a transparent methodology and reporting
structure that includes a conflict of interest policy, and that establishes standards
of care informed by a systematic review of evidence and an assessment of the
benefits and risks of alternative care options, including recommendations
intended to optimize patient care.
(b) A health insurer that issues, amends, delivers, or renews a contract or
agreement for a health benefit plan to take effect on or after January 1, 2026, shall
include coverage for biomarker testing pursuant to subsection (c).
(c) A health benefit plan must provide coverage for biomarker testing for the
purposes of 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, but not limited to:
(1) Labeled indications for a federal food and drug administration (FDA)-
approved or FDA-cleared test;
(2) Indicated tests for an FDA-approved drug;
- 3 - 001522
(3) Warnings and precautions on FDA-approved drug labels;
(4) Centers for medicare and medicaid services national coverage
determinations or medicare administrative contractor local coverage
determinations; or
(5) Nationally recognized clinical practice guidelines and consensus
statements.
(d) A health insurer shall ensure that biomarker testing coverage under this
section is provided in a manner that limits disruptions in care, including the need for
multiple biopsies or biospecimen samples.
(e) If utilization review, including, but not limited to, prior authorization is
required, then the health insurer, nonprofit health service plan, health maintenance
organization, utilization review entity, or a third party acting on behalf of an organization
or entity subject to this section must approve or deny a prior authorization request and
notify the enrollee, the enrollee's healthcare provider, and each entity requesting
authorization of the service within seventy-two (72) hours of a non-urgent request or
within twenty-four (24) hours of an urgent request.
(f) A patient and prescribing practitioner shall have access to a clear, readily
accessible, and convenient process to request an exception to a coverage policy or an
adverse utilization review determination of a health insurer, nonprofit health service plan,
or health maintenance organization. The process must be made readily accessible on
the public website of the health insurer, nonprofit health service plan, or health
maintenance organization.
SECTION 2. Tennessee Code Annotated, Title 71, Chapter 5, Part 1, is amended by
adding the following as a new section:
(a) As used in this section:
- 4 - 001522
(1) "Biomarker" has the same meaning as defined in SECTION 1;
(2) "Biomarker testing" has the same meaning as defined in SECTION 1;
(3) "Consensus statement" has the same meaning as defined in
SECTION 1;
(4) "Health benefit plan" means health insurance coverage as defined in
§ 56-7-109;
(5) "Health insurer" means a health insurance entity as defined in § 56-7-
109;
(6) "Nationally recognized clinical practice guideline" has the same
meaning as defined in SECTION 1; and
(7) "TennCare health benefit plan" means a health benefit plan issued by
a health insurer pursuant to an agreement with the bureau of TennCare to
provide health insurance coverage for an enrollee in the medical assistance
program.
(b) A TennCare health benefit plan that is issued, amended, or renewed to take
effect on or after January 1, 2026, must provide coverage for biomarker testing.
(c) Biomarker testing must be covered for the purposes of 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, but not limited
to:
(1) Labeled indications for a federal food and drug administration (FDA)-
approved or FDA-cleared test;
(2) Indicated tests for an FDA-approved drug;
(3) Warnings and precautions on FDA-approved drug labels;
- 5 - 001522
(4) Centers for medicare and medicaid services national coverage
determinations or medicare administrative contractor local coverage
determinations; or
(5) Nationally recognized clinical practice guidelines and consensus
statements.
(d) A health insurer that issues a TennCare health benefit plan shall provide
biomarker testing within the same scope, and at the same duration and frequency, that
other TennCare benefits are provided to enrollees.
(e) If utilization review, including, but not limited to, prior authorization is
required, then the health insurer, nonprofit health service plan, health maintenance
organization, utilization review entity, or a third party acting on behalf of an organization
or entity subject to this section must approve or deny a prior authorization request and
notify the enrollee, the enrollee's healthcare provider, and each entity requesting
authorization of the service within seventy-two (72) hours of a non-urgent request or
within twenty-four (24) hours of an urgent request.
(f) An enrollee and participating provider must have access to a clear, readily
accessible, and convenient process to request an exception to a coverage policy of, or
an adverse utilization review by, a health insurer that issues a TennCare health benefit
plan. The process must be made readily accessible on the public website of TennCare
and each health insurer that issues TennCare health benefit plans.
(g) The director of TennCare is authorized to seek any federal waiver the
director deems necessary to effectuate this section.
SECTION 3. The commissioner of commerce and insurance is authorized to promulgate
rules to effectuate Section 1 of this act. The rules must be promulgated in accordance with the
Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
- 6 - 001522
SECTION 4. This act takes effect upon becoming a law, the public welfare requiring it.