Bill Text: IL SB3734 | 2023-2024 | 103rd General Assembly | Introduced

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Bill Title: Amends the Medical Patient Rights Act. Requires the Department of Public Health to develop an expanded informed consent document and expanded informed consent process for all patients scheduled to undergo atherectomy.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2024-02-09 - Referred to Assignments [SB3734 Detail]

Download: Illinois-2023-SB3734-Introduced.html

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103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 SB3734 Introduced 2/9/2024, by Sen. Ram Villivalam SYNOPSIS AS INTRODUCED:
410 ILCS 50/5.3 new
Amends the Medical Patient Rights Act. Requires the Department of Public Health to develop an expanded informed consent document and expanded informed consent process for all patients scheduled to undergo atherectomy.
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A BILL FOR
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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Medical Patient Rights Act is amended by
adding Section 5.3 as follows:
(410 ILCS 50/5.3 new)
Sec. 5.3. Informed consent for patients undergoing
atherectomy.
(a) By October 1, 2024, the Department of Public Health
shall develop an expanded informed consent document and
expanded informed consent process for all patients scheduled
to undergo atherectomy, which is a procedure that involves
opening arteries blocked by plaque using a long, narrow tube
with a sharp blade, laser or rotating device on the end to
scrape away, dissolve, or break up plaque without making a
large incision. The expanded informed consent document and
expanded informed consent process shall be completed and shall
include, at a minimum, all of the following:
(1) all informed consent questions required by federal
law, including, but not limited to, questions that
address:
(A) the nature of the procedure;
(B) the risks and benefits of the procedure;

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(C) reasonable alternatives to the procedure;
(D) the risks and benefits of alternative
treatment options; and
(E) the patient's understanding of the factors
described in subparagraphs (A) through (D).
(2) a description of the specific risks and outcomes
that are associated with atherectomies and that are
identified by the National Institutes of Health,
including, but not limited to:
(A) the impact that smoking has on the patient's
risk of repeated claudication;
(B) the impact that smoking will have after
claudication;
(C) the increased risk that occurs when 2 or more
arteries are treated, including, but not limited to, a
shorter time to repeat claudication, duration between
procedures, or an increased likelihood that a repeat
atherectomy or another surgical intervention may be
needed;
(D) common complications that may result from
atherectomy, including, but not limited to, the
perforation of an artery, and the likelihood of death
after these complications;
(E) the impact of atherectomy on long-term health,
including, but not limited to, the likelihood of a
major adverse limb event, amputation, and repeated

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atherectomies;
(F) the increased likelihood of death, amputation,
and repeat atherectomies, based on race or ethnicity;
and
(G) a description of how Black and hispanic
patients have a significantly greater risk of death
after amputation, if the atherectomy results in a
major amputation.
(d) The expanded informed consent process shall require:
(1) the informed consent document to be first read and
completed directly by the patient;
(2) after the informed consent document is read and
completed by the patient, a health provider to read each
line of the informed consent document to the patient and
document the patient's answers;
(3) the provider to record any discrepancies between
the patient's written answers and the patient's verbal
answers as documented by the provider;
(4) the provider and the patient to sign the document;
(5) the provider to provide copies of the informed
consent documents to the patient; and
(6) the provider to retain and store a copy of the
document in medical records.
(e) The informed consent document shall minimally include:
(1) one column for patient answers and one column for
the provider to record the patient's verbal answers; and

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