RDCSB204 3264 2688
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 204 Engrossed 2020 Regular Session Talbot
Present law requires a health insurance issuer to provide coverage for the costs of
investigational treatments and associated protocol-related patient care if treatment is
provided or a study is conducted in a Phase II, Phase III, or Phase IV clinical trial for cancer.
Proposed law retains present law and extends coverage to a treatment provided or study
conducted in a Phase I clinical trial for cancer.
Proposed law does not require a health insurance issuer to provide coverage for the
following:
(1)Non-healthcare services provided as part of the clinical trial.
(2)Costs for managing research data associated with the clinical trial.
(3)Investigational drugs, devices, items, or services associated with the clinical trial.
Proposed law prohibits a health coverage plan delivered or issued for delivery in this state
from denying coverage for the treatment of metastatic or unresectable tumors with a
medically necessary drug prescribed by a physician on the sole basis that the drug is not
indicated for the location in the body of the patient's cancer, if the drug is approved by the
United States Food and Drug Administration (FDA) for the treatment of the specific
mutation of the patient's cancer.
Proposed law further provides that coverage may be denied if an alternative treatment has
proven to be more effective in published randomized clinical trials and is not contraindicated
in the patient.
Proposed law requires any health coverage plan delivered or issued for delivery in this state
to include coverage for a minimum initial treatment period of at least 3 months for a
medically necessary drug prescribed by a physician that is not indicated for the location in
the body of the patient's cancer, if the drug is approved by the FDA for the treatment of the
specific mutation of the patient's cancer.
Proposed law requires the health coverage plan to continue to provide coverage of the
prescribed drug after the initial treatment period if the treating physician certifies that the
prescribed drug is medically necessary for the treatment of the patient's cancer, based on
documented improvement of the patient.
Effective Jan. 1, 2021.
(Amends R.S. 22:1044(E)(2); Adds R.S. 22:1054.1)
Summary of Amendments Adopted by House
The Committee Amendments Proposed by House Committee on Insurance to the
engrossed bill:
1. Modify the title to add citations and descriptions relative to Phase 1 clinical trials
for cancer.
2. Provide that a health coverage plan is not required to cover non-healthcare
services, costs for managing research data, investigational drugs, devices, items,
or services associated with clinical trials. RDCSB204 3264 2688
3. Prohibit a health coverage plan from denying coverage for the treatment of
metastatic or unresectable tumors with a medically necessary drug prescribed by
a physician under certain circumstances.
4. Provide that coverage may be denied if an alternative treatment proves to be
more effective in published randomized clinical trials and is not contraindicated
in the patient.
5. Modify proposed law to require a health coverage plan to continue to provide
coverage of a prescribed drug after the initial treatment period if the drug is
physician-certified as medically necessary for the treatment of the patient's
cancer, based on documented improvement of the patient.
6. Provide an effective date of Jan. 1, 2021 and require any policy, contract, or
health coverage plan currently in place to comply with present and proposed law
by Jan. 1, 2022.
7. Make technical changes.