RDCSB118 3264 3668 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 118 Engrossed 2022 Regular Session Talbot Present law requires a health coverage plan in this state to include coverage for genetic or molecular testing for cancer including but not limited to tumor mutation testing, next generation sequencing, hereditary germline mutation testing, pharmacogenomic testing, whole exome and genome sequencing, and biomarker testing. Proposed law retains present law. Present law provides that coverage may be subject to annual deductibles, coinsurance, and copayments established under a health coverage plan. Proposed law retains present law. Present law provides that coverage may be subject to applicable evidence-based medical necessity criteria of a health coverage plan. Proposed law deletes present law. Proposed law requires coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an individual's disease or condition when the test is supported in certain respects by any of the following: the U.S. Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services National Coverage Determinations, Medicare Administrative Contractor Local Coverage Determinations, National Comprehensive Cancer Network, or American Society of Clinical Oncology. Present law defines "biomarker testing". Proposed law expands the definition to include whole exome and whole transcriptome sequencing. Otherwise retains the present law definition. Proposed law defines "consensus statements" and "nationally recognized clinical practice guidelines". Effective on July 1, 2022. (Amends R.S. 22:1028.3(B)(2) and (D)(intro. para.) and (2); Adds R.S. 22:1028.3(D)(3) and (4)) Summary of Amendments Adopted by Senate Committee Amendments Proposed by Senate Committee on Insurance to the original bill 1. Makes technical changes. 2. Adds provision requiring an insurer cover biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an individual's disease or condition when the test is supported by, but not limited to labeled indications for tests approved or cleared by the United States Food and Drug Administration (FDA), or indicated tests for drugs approved by the FDA, or the Centers for Medicare and Medicaid Services National Coverage Determinations, or Medicare Administrative Contractor Local Coverage Determinations, or a nationally recognized clinical practice guidelines and consensus statements. 3. Adds definitions for "consensus statements" and a "nationally recognized clinical practice guidelines". Page 1 of 2 RDCSB118 3264 3668 Summary of Amendments Adopted by House The Committee Amendments Proposed by House Committee on Insurance to the engrossed bill: 1. Add that biomarker tests may be supported for coverage by nationally recognized consensus statements and clinical practice guidelines provided by the National Comprehensive Cancer Network or the American Society of Clinical Oncology. 2. Modify the definition of "biomarker testing" to include whole exome and whole transcriptome sequencing. 3. Make technical changes including modifications to the definitions of "consensus statements" and "nationally recognized clinical practice guidelines". Page 2 of 2