Shown verbatim: the complete text as captured from the official PDF posted by the Tennessee General Assembly, fetched 2026-09-25. Page and line markers are part of the official record; nothing is edited or removed. This is the chaptered version. The official bill page.
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~tate of \ltenne~~ee
PUBLIC CHAPTER NO. 929
HOUSE BILL NO. 484
By Representatives Brock Martin, Hemmer, Helton-Haynes, Behn, White, Warner, Boyd,
Freeman, Moody, Renea Jones, Hakeem, Parkinson, Sherrell, Terry, Faison, Hale,
McKenzie, Kumar, Rudder, Towns, Slater, Sparks, McCalmon, Harris, Hardaway,
Clemmons, Russell, Maberry, Capley, Reeves, Gillespie, Lamberth, Brooks, Camper,
Davis, Miller, Chism
Substituted for: Senate Bill No. 435
By Senators Reeves, Akbari, Campbell, Rose, Jackson, Hensley, White, Bailey, Bowling,
Hatcher, Walley
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:
56-7-2369.
(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
(8) 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
(8) Includes single-analyte tests, multi-plex panel tests, protein
expression, and whole exome, whole genome, and whole transcriptome
sequencing;
(3) "Health benefit plan" means health insurance coverage as defined in §
56-7-109 that is offered under a state or local insurance program pursuant to title
8, chapter 27;
(4) "Health insurer" means a health insurance entity, as defined in§ 56-7-
109, that offers a hea1th benefit plan; and
(5) "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.
HB484
(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, 2027, shall
include coverage for biomarker testing pursuant to subsection (c).
(c) A health benefit plan must provide coverage for biomarker testing when
ordered by a healthcare provider for the purposes of diagnosis, treatment, appropriate
management, or ongoing monitoring to guide treatment decisions for 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;
(4) Centers for medicare and medicaid services national coverage
determinations or medicare administrative contractor local coverage
determinations; or
(5) Nationally recognized clinical practice guidelines.
(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) This section does not require coverage of biomarker testing for the purpose of
screening asymptomatic individuals.
(f) 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 in accordance with state law.
(g) A patient and prescribing practitioner must 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.
(h) This section does not limit a health insurer's ability to require prior
authorization or other utilization management techniques.
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:
(1) "Biomarker" has the same meaning as defined in§ 56-7-2369;
(2) "Biomarker testing" has the same meaning as defined in § 56-7-2369;
(3) "Health benefit plan" means health insurance coverage as defined in §
56-7-109;
(4) "Health insurer" means a health insurance entity as defined in§ 56-7-
109;
(5) "Nationally recognized clinical practice guideline" has the same
meaning as defined in§ 56-7-2369; and
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HB484
(6) "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 on or
after January 1, 2027, must provide coverage for biomarker testing when medically
necessary pursuant to§ 71-5-144.
(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;
(4) Centers for medicare and medicaid services national coverage
determinations or medicare administrative contractor local coverage
determinations; or
(5) Nationally recognized clinical practice guidelines.
(d) A health insurer that issues a TennCare health benefit plan that covers
biomarker testing 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 in accordance with 42 CFR Part 438.
(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.
(h)
(1) The commissioner of commerce and insurance shall compile a report
on the usage of covered biomarker testing and cost savings generated pursuant
to this section, based upon data reported to the department of commerce and
insurance by health insurers.
(2) The commissioner may establish reporting standards by rule for the
purpose of compiling data necessary to complete the report required by this
subsection (h). The rules must be promulgated in accordance with the Uniform
Administrative Procedures Act, compiled in title 4, chapter 5.
(3) No later than February 1, 2029, the commissioner shall deliver a copy
of the report to the chief clerk of the senate, the chief clerk of the house of
representatives, and the legislative librarian. The report may be delivered by
electronic means.
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HB484
SECTION 3. The commissioner of commerce and insurance may 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.
SECTION 4. This act takes effect upon becoming a law, the public welfare requiring it.
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HOUSE BILL NO. 484
PASSED: April 16, 2026
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CAMERONSEXTON,SPEAKER
HOUSE OF REPRESENTATIVES
RANDY MCNAIi-Y
SPEAKER OF THE SENAtE
APPROVED this J_tl day of (V:'t:u...1~1• 2026
BILL LEE, GOVERNOR uEvery fact on this page links to its source, starting with the official bill record.