State of Illinois
2023 and 2024


Introduced 2/9/2024, by Sen. Ram Villivalam


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.

LRB103 38783 CES 68920 b





SB3734LRB103 38783 CES 68920 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 5. The Medical Patient Rights Act is amended by
5adding Section 5.3 as follows:
6    (410 ILCS 50/5.3 new)
7    Sec. 5.3. Informed consent for patients undergoing
9    (a) By October 1, 2024, the Department of Public Health
10shall develop an expanded informed consent document and
11expanded informed consent process for all patients scheduled
12to undergo atherectomy, which is a procedure that involves
13opening arteries blocked by plaque using a long, narrow tube
14with a sharp blade, laser or rotating device on the end to
15scrape away, dissolve, or break up plaque without making a
16large incision. The expanded informed consent document and
17expanded informed consent process shall be completed and shall
18include, at a minimum, all of the following:
19        (1) all informed consent questions required by federal
20    law, including, but not limited to, questions that
21    address:
22            (A) the nature of the procedure;
23            (B) the risks and benefits of the procedure;



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



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



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1        (2) a space to reconcile discrepancies that exist
2    between the patient's written answers and the patient's
3    verbal answers as documented by the provider.
4    (f) Given the significant risks associated with
5atherectomies, providers shall ask the patient their preferred
6or native language and all informed consent documents and
7verbal questions asked by the provider shall be in the
8language requested by the patient.