SLS 22RS-264 ENGROSSED
2022 Regular Session
SENATE BILL NO. 118
BY SENATOR TALBOT
HEALTH/ACC INSURANCE. Requires medical necessity for genetic testing of certain
cancer mutations is based on nationally recognized clinical practice guidelines. (7/1/22)
1 AN ACT
2 To amend and reenact R.S. 22:1028.3(B)(2) and to enact R.S. 22:1028.3(D)(3) and (4),
3 relative to the medical necessity for genetic testing of certain cancer mutations; to
4 require medical necessity for genetic testing of certain cancer mutations is based on
5 nationally recognized clinical practice guidelines; to provide definitions; and to
6 provide for related matters.
7 Be it enacted by the Legislature of Louisiana:
8 Section 1. R.S. 22:1028.3(B)(2) is hereby amended and reenacted and R.S.
9 22:1028.3(D)(3) and (4) are hereby enacted to read as follows:
10 ยง1028.3. Required coverage for genetic testing for cancer
11 B.(1) * * *
12 (2) The coverage provided in this Section may be subject to annual
13 deductibles, coinsurance, and copayment provisions as are consistent with those
14 established under the health coverage plan. The coverage provided under this Section
15 may be subject to applicable evidence-based medical necessity criteria under the
16 plan. The biomarker test shall be covered for the purposes of diagnosis,
17 treatment, appropriate management or ongoing monitoring of an individual's
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions. SB NO. 118
SLS 22RS-264 ENGROSSED
1 disease or condition when the test is supported by medical and scientific
2 evidence, including but not limited to the following:
3 (a) Labeled indications for tests are approved or cleared by the United
4 States Food and Drug Administration or indicated tests for a drug that is
5 approved by the United States Food and Drug Administration.
6 (b) Centers for Medicare and Medicaid Services National Coverage
7 Determinations or Medicare Administrative Contractor Local Coverage
8 Determinations.
9 (c) Nationally recognized clinical practice guidelines and consensus
10 statements.
11 * * *
12 D. As used in this Section, the following definitions shall apply unless the
13 context indicates otherwise:
14 (1) * * *
15 (3) "Consensus statements" means statements developed by an
16 independent, multidisciplinary panel of experts utilizing a transparent
17 methodology and reporting structure and with a conflict-of-interest policy and
18 these statements are aimed at specific clinical circumstances and base the
19 statements on the best available evidence for the purposes of optimizing the
20 outcomes of clinical care.
21 (4) "Nationally recognized clinical practice guidelines" means evidence-
22 based clinical guidelines developed by independent organizations or medical
23 professional societies utilizing a transparent methodology and reporting
24 structure and with a conflict-of-interest policy and clinical guidelines establish
25 standards of care informed by a systematic review of evidence and an
26 assessment of the benefits and costs alternative care options and include
27 recommendations intended to optimize patient care.
28 Section 2. This Act shall become effective on July 1, 2022.
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions. SB NO. 118
SLS 22RS-264 ENGROSSED
The original instrument and the following digest, which constitutes no part
of the legislative instrument, were prepared by Beth O'Quin.
DIGEST
SB 118 Engrossed 2022 Regular Session Talbot
Present law provides coverage can be subject to annual deductibles, coinsurance, copayment
provisions established under a health coverage plan and coverage for genetic testing of
certain cancer mutations can be subject to applicable evidence-based medical necessity
criteria under a health plan.
Proposed law retains present law, but requires an insurer to 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 the 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.
Present law provides definitions for "biomarker" and "biomarker test".
Proposed law retains present law but adds definitions for "consensus statements" and
"nationally recognized clinical practice guidelines".
Effective on July 1, 2022.
(Amends R.S. 22:1028.3(B)(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".
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.