SB 435

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)-appr ov ed 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 a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. 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 must approve or deny a pri or authorization request and notify the enrollee, the enrollee's healthcare provider, and each entity requesting authorization of the service within 72 hours of a non-urgent request or within 24 hours of an urgent request. This bill requires a patient and prescribing practitioner to 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 hea lth 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. This bill authorizes the commissioner of commerce and insurance to promulgate rules to effectuate this bill. TENNCARE This bill requires a TennCare health benefit plan that is issued, amended, or renewed to take effect on or after January 1, 2026, to provide coverage for biomarker testing. Biomarker testing must be covered for the purposes of diagnosis, treatment, appr opriate 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 o r 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 cov erage determinations; or (v) nationally recognized clinical practice guidelines and consensus statements. This bill requires a health insurer that issues a TennCare health benefit plan to provide biomarker testing within the same scope, and at the same duration and frequency, that other TennCare benefits are provided to enrollees. If utilization review, inc luding, 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 must approve or d eny a prior authorization request and notify the enrollee, the enrollee's healthcare provider, and each entity requesting authorization of the service within 72 hours of a non-urgent request or within 24 hours of an urgent request. This bill requires an enrollee and participating provider to 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. This bill authorizes the director of TennCare is authorized to seek any federal waiver the director deems necessary to effectuate this bill. ON MARCH 30, 2026, THE HOUSE ADOPTED AMENDMENT #2 AND PASSED HOUSE BILL 484, AS AMENDED. AMENDMENT #2 limits this bill's coverage mandate for biomarker testing to group insurance plans for public employees and TennCare. This amendment makes the coverage mandate applicable to policies that are issued, amended, delivered, or renewed on or after January 1, 2027. This amendment conditions coverage for biomarker testing to situations when a health care provider or ders such testing, or, in the case of TennCare, when medically necessary. This amendment specifies that coverage of biomarker testing is not mandatory for the purpose of screening asymptomatic individuals. This amendment removes the deadlines for utilization review decisions under this bill, with were 24 hours for urgent requests and within 72 hours for non-urgent requests. This amendment specifies that this bill does not limit a health insurer's ability to require prior authorization or other utilization management techniques. This amendment requires the commissioner of commerce and insurance to compile a report on the usage of covered biomarker testing and cost savings generated for TennCare, based upon data reported to the department of commerce and insurance by health insur ers. The commissioner may establish reporting standards by rule for the purpose of compiling data necessary to complete the report. This amendment requires the commissioner to deliver the report no later than February 1, 2029.