Tennessee legislation · 114th General Assembly
Tennessee SB435: AN ACT to amend Tennessee Code Annotated, Title 56 and Title 71, relative to coverage of biomarker testing.
Status: Chaptered, May 14, 2026
Fiscal Summary STATE GOVERNMENTEXPENDITURESGeneral FundFY25-26$1,465,700FY26-27 & Subsequent Years$2,931,500 OTHER FISCAL IMPACT Increased biomarker testing utilization under the Division of TennCare and the State Group Insurance Program could result in increased expenditures for such additional services; however, the precise amounts of such increases attributable to the proposed legislation cannot be quantified with reasonable certainty. Potential Impact on Health Insurance Premiums (required by Tenn. Code Ann. § 3-2-111): Such legislation will result in an increase in the cost of health insurance premiums for procedures and treatments being provided by plans that do not currently offer these benefits at the proposed mandated levels. It is estimated that the increase to each individual’s total premium will be less than one percent. Bill Summary HEALTH INSURERS This bill requires 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, to include 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, (i) labeled indications for a federal food and drug administration (FDA)-approved or FDA-cleared test; (ii) indicated tests for an FDA-approved drug; (iii) warnings and precautions on FDA-approved drug labels; (iv) centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations; or (v) nationally recognized clinical practice guidelines and consensus statements. This bill requires a health insurer to ensure that biomarker testing coverage under this bill is provided in
What the bill says
From the amended text:
Senate Commerce and Labor 1 Amendment No. 1 to SB0435 Bailey Signature of Sponsor AMEND S e n ate Bill No. 435* House Bill No. 484 by deleting all language after the enacting clause and substituting: 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 (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; SA1015 (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 § 567-109, that offers a health benefit plan; and (5) "Nationally recognized clinical practice guideline" means an evidencebased clinical practice guideline …