RDCSB104 3264 3864
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
SB 104 Engrossed 2023 Regular Session Stine
Proposed law outlines legislative findings and requires any health coverage plan 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.
Proposed 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.
Proposed 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
determination of a health coverage plan. Further requires the process to be included on a
health coverage plan's website or be clearly outlined in the notification of adverse
determination.
Proposed law requires a health coverage plan to ensure that coverage in proposed law is
provided in a manner that limits disruptions in care, including the need for multiple biopsies
or biospecimen samples.
Proposed law defines "biomarker", "biomarker testing", "clinical utility", "health coverage
plan", and "nationally recognized clinical practice guidelines".
Proposed law applies to any new policy, contract, program, or health coverage plan issued
on and after Jan. 1, 2024. Further requires any policy, contract, or health coverage plan in
effect prior to Jan. 1, 2024, to convert to conform to proposed law on before the renewal
date, but no later than Jan. 1, 2025.
(Adds R.S. 22:1028.5)
Summary of Amendments Adopted by Senate
Committee Amendments Proposed by Senate Committee on Insurance to the original
bill
1. Provides that tests are diagnostic tests.
2. Makes technical changes.
Summary of Amendments Adopted by House
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The Committee Amendments Proposed by House Committee on Insurance to the
engrossed bill:
1. Add that a biomarker test may identify any other medical condition.
2. Delete the definition of "consensus statements" and applicable references.
3. Define "clinical utility" and provide applicable references.
4. Add that proposed law does not require a health coverage plan to cover
biomarker testing for screening purposes.
5. Add that the process for making exceptions to coverage may also be clearly
outlined in a notification of adverse determination.
6. Add that proposed law applies to any new policy, contract, program, or health
coverage plan issued on and after Jan. 1, 2024. Require any policy, contract, or
health coverage plan in effect prior to Jan. 1, 2024, to convert to conform to
proposed law on before the renewal date, but no later than Jan. 1, 2025.
7. Make technical changes.
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