HLS 20RS-650 ORIGINAL
2020 Regular Session
HOUSE BILL NO. 407
BY REPRESENTATIVE LACOMBE
INSURANCE/HEALTH: Provides for health insurance coverage for participants in clinical
trials
1 AN ACT
2To amend and reenact R.S. 22:1044(E)(2), relative to insurance coverage for participation
3 in a clinical trial; to require health insurance coverage for a treatment provided or
4 study conducted in a Phase I clinical trial for cancer; to provide for an effective date;
5 and to provide for related matters.
6Be it enacted by the Legislature of Louisiana:
7 Section 1. R.S. 22:1044(E)(2) is hereby amended and reenacted to read as follows:
8 ยง1044. Health coverage; participants in clinical trials
9 * * *
10 E. Costs of investigational treatments and costs of associated protocol-
11 related patient care shall be covered if all of the following criteria are met:
12 * * *
13 (2) The treatment is being provided or the studies are being conducted in a
14 Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer.
15 * * *
16 Section 2. This Act shall become effective upon signature by the governor or, if not
17signed by the governor, upon expiration of the time for bills to become law without signature
18by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If
19vetoed by the governor and subsequently approved by the legislature, this Act shall become
20effective on the day following such approval.
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions. HLS 20RS-650 ORIGINAL
HB NO. 407
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)]
HB 407 Original 2020 Regular Session LaCombe
Abstract: Requires health insurance coverage for a treatment provided or study conducted
in a Phase I clinical trial for cancer.
Present law requires a health insurance issuer to provide coverage for the costs of
investigational treatments and associated protocol-related patient care if all of the following
criteria are met:
(1)The treatment is being provided with a therapeutic or palliative intent for patients
with cancer, or for the prevention or early detection of cancer.
(2)The treatment is being provided or the studies are being conducted in a Phase II,
Phase III, or Phase IV clinical trial for cancer.
(3)The treatment is being provided in accordance with a clinical trial approved by
certain entities.
(4) The proposed protocol has been reviewed and approved by a qualified institutional
review board which operates in this state and which has a multiple project assurance
contract approved by the office of protection from research risks.
(5)The facility and personnel providing the protocol provided the treatment within their
scope of practice, experience, and training and are capable of doing so by virtue of
their experience, training, and volume of patients treated to maintain expertise.
(6) There is no clearly superior, non-investigational approach.
(7)The available clinical or preclinical data provide a reasonable expectation that the
treatment will be at least as efficacious as the non-investigational alternative.
(8)The patient has signed an institutional review board-approved consent form.
Proposed law retains present law and extends coverage to a treatment provided or study
conducted in a Phase I clinical trial for cancer.
Effective upon signature of governor or lapse of time for gubernatorial action.
(Amends R.S. 22:1044(E)(2))
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions.