103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB2438

 

Introduced 2/15/2023, by Rep. Camille Y. Lilly

 

SYNOPSIS AS INTRODUCED:
 
305 ILCS 5/5-5.28 new

    Amends the Medical Assistance Article of the Illinois Public Aid Code. Provides that the medical assistance program shall provide coverage for routine care costs that are incurred in the course of an approved clinical trial if the medical assistance program would provide coverage for the same routine care costs not incurred in a clinical trial. Defines "approved clinical trial" to mean a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life-threatening disease or condition. Defines "routine care cost" to mean the cost of medically necessary services related to the care method that is under evaluation in a clinical trial, including the cost of services related to the detection and treatment of any complications arising from the patient's medical care and any complications related to participation in the clinical trial. Defines other terms.


LRB103 28969 KTG 55355 b

 

 

A BILL FOR

 

HB2438LRB103 28969 KTG 55355 b

1    AN ACT concerning public aid.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Public Aid Code is amended by
5changing Section 5-5.28 as follows:
 
6    (305 ILCS 5/5-5.28 new)
7    Sec. 5-5.28. Coverage for clinical trials.
8    (a) The medical assistance program shall provide coverage
9for routine care costs that are incurred in the course of an
10approved clinical trial if the medical assistance program
11would provide coverage for the same routine care costs not
12incurred in a clinical trial.
13    (b) The coverage that must be provided under this Section
14is subject to the terms, conditions, restrictions, exclusions,
15and limitations that apply generally under the medical
16assistance program, including terms, conditions, restrictions,
17exclusions, or limitations that apply to health care services
18rendered by participating providers and nonparticipating
19providers.
20    (c) As used in this Section:
21    "Approved clinical trial" means a phase I, II, III, or IV
22clinical trial involving the prevention, detection, or
23treatment of cancer or any other life-threatening disease or

 

 

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1condition if one or more of the following conditions apply:
2        (1) the Department makes a determination that the
3    study or investigation is an approved clinical trial;
4        (2) the study or investigation is conducted under an
5    investigational new drug application or an investigational
6    device exemption reviewed by the federal Food and Drug
7    Administration;
8        (3) the study or investigation is a drug trial that is
9    exempt from having an investigational new drug application
10    or an investigational device exemption from the federal
11    Food and Drug Administration; or
12        (4) the study or investigation is approved or funded
13    (which may include funding through in-kind contributions)
14    by:
15            (A) the National Institutes of Health;
16            (B) the Centers for Disease Control and
17        Prevention;
18            (C) the Agency for Healthcare Research and
19        Quality;
20            (D) the Patient-Centered Outcomes Research
21        Institute;
22            (E) the federal Centers for Medicare and Medicaid
23        Services;
24            (F) a cooperative group or center of any of the
25        entities described in subparagraphs (A) through (E) or
26        the United States Department of Defense or the United

 

 

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1        States Department of Veterans Affairs;
2            (G) a qualified non-governmental research entity
3        identified in the guidelines issued by the National
4        Institutes of Health for center support grants; or
5            (H) the United States Department of Veterans
6        Affairs, the United States Department of Defense, or
7        the United States Department of Energy, provided that
8        review and approval of the study or investigation
9        occurs through a system of peer review that is
10        comparable to the peer review of studies performed by
11        the National Institutes of Health, including an
12        unbiased review of the highest scientific standards by
13        qualified individuals who have no interest in the
14        outcome of the review.
15    "Care method" means the use of a particular drug or device
16in a particular manner.
17    "Life-threatening disease or condition" means a disease or
18condition from which the likelihood of death is probable
19unless the course of the disease or condition is interrupted.
20    "Routine care cost" means the cost of medically necessary
21services related to the care method that is under evaluation
22in a clinical trial. Routine care costs include the cost of
23services related to the detection and treatment of any
24complications arising from the patient's medical care,
25including any complications related to participation in the
26clinical trial. The term does not include the following:

 

 

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1        (1) The drug or device that is under evaluation in a
2    clinical trial.
3        (2) Items or services that are:
4            (A) provided solely for data collection and
5        analysis and not in the direct clinical management of
6        an individual enrolled in a clinical trial;
7            (B) customarily provided at no cost by a research
8        sponsor to an individual enrolled in a clinical trial;
9        or
10            (C) provided solely to determine eligibility of an
11        individual for participation in a clinical trial.