RÉSUMÉ DIGEST
ACT 324 (SB 104) 2023 Regular Session Stine
New law requires any health coverage plan that is renewed, delivered, or issued for delivery
in this state to include coverage for biomarker testing for the purpose of the diagnosis,
treatment, appropriate management, or ongoing monitoring of an individual's disease or
condition when the test provides clinical utility as demonstrated by medical and scientific
evidence, including any one of the following:
(1)Labeled indications for diagnostic tests approved or cleared by the U.S. Food and
Drug Administration (FDA) or indicated diagnostic tests for a drug approved by the
FDA.
(2)Warnings and precautions listed on a FDA-approved drug label.
(3)National Coverage Determinations of the Centers for Medicare and Medicaid
Services or Local Coverage Determinations of Medicare Administrative Contractors.
(4)Nationally recognized clinical practice guidelines.
New law provides that coverage may be subject to annual deductibles, coinsurance, and
copayment provisions as are consistent with those established under the health coverage
plan.
New law requires individuals and healthcare providers to have access to a clear, readily
accessible, convenient process to request exceptions to a coverage policy or adverse
utilization review determination of a health coverage plan. New law further requires the
process be included on a health coverage plan's website or be clearly outlined in the
notification of adverse determination.
New law requires a health coverage plan to ensure that coverage is provided in a manner that
limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
New law defines "biomarker", "biomarker testing", "clinical utility", "health coverage plan",
and "nationally recognized clinical practice guidelines".
New law applies to any new policy, contract, program, or health coverage plan issued on and
after the January first immediately following the effective date of new law. New law further
requires any policy, contract, or health coverage plan in effect prior to the effective date of
new law to convert to conform to new law on or before the renewal date, but no later than
the first January first that is at least one year after the effective date of this Act.
Effective date is subject to appropriation of monies by the legislature.
(Adds R.S. 22:1028.5)