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1 | AN ACT concerning State government, which may be referred | |||||||||||||||||||
2 | to as Lilly's Law.
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3 | Be it enacted by the People of the State of Illinois,
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4 | represented in the General Assembly:
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5 | Section 5. The Department of Public Health Powers and | |||||||||||||||||||
6 | Duties Law of the
Civil Administrative Code of Illinois is | |||||||||||||||||||
7 | amended by adding Section 2310-640 as follows: | |||||||||||||||||||
8 | (20 ILCS 2310/2310-640 new)
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9 | Sec. 2310-640. Neonatal Diabetes Mellitus Registry Pilot | |||||||||||||||||||
10 | Program. | |||||||||||||||||||
11 | (a) In this Section, "neonatal diabetes mellitus research | |||||||||||||||||||
12 | institution" means an Illinois academic medical research | |||||||||||||||||||
13 | institution that (i) conducts research in the area of diabetes | |||||||||||||||||||
14 | mellitus with onset before 12 months of age and (ii) is | |||||||||||||||||||
15 | functioning in this capacity as of the effective date of this | |||||||||||||||||||
16 | amendatory Act of the 96th General Assembly. | |||||||||||||||||||
17 | (b) The Department, subject to appropriation or other funds | |||||||||||||||||||
18 | made available for this purpose, shall develop and implement a | |||||||||||||||||||
19 | 3-year pilot program to create and maintain a monogenic | |||||||||||||||||||
20 | neonatal diabetes mellitus registry. The Department shall | |||||||||||||||||||
21 | create an electronic registry to track the glycosylated | |||||||||||||||||||
22 | hemoglobin level of each person with monogenic neonatal | |||||||||||||||||||
23 | diabetes who has a laboratory test to determine that level |
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1 | performed by a physician or healthcare provider or at a | ||||||
2 | clinical laboratory in this State. The Department shall | ||||||
3 | facilitate collaborations between participating physicians and | ||||||
4 | other healthcare providers and the Kovler Diabetes Center at | ||||||
5 | the University of Chicago in order to assist participating | ||||||
6 | physicians and other healthcare providers with genetic testing | ||||||
7 | and follow-up care for participating patients. | ||||||
8 | The goals of the registry are as follows: | ||||||
9 | (1) to help identify new and existing patients with | ||||||
10 | neonatal diabetes; | ||||||
11 | (2) to provide a clearinghouse of information for | ||||||
12 | individuals, their families, and doctors about these | ||||||
13 | syndromes; | ||||||
14 | (3) to keep track of patients with these mutations who | ||||||
15 | are being treated with sulfonylurea drugs and their | ||||||
16 | treatment outcomes; and | ||||||
17 | (4) to help identify new genes responsible for | ||||||
18 | diabetes. | ||||||
19 | (c) Physicians and other healthcare providers treating a | ||||||
20 | patient in this State with diabetes mellitus with onset before | ||||||
21 | 12 months of age shall
report to the Department the following | ||||||
22 | information from all such cases no more than 30 days after | ||||||
23 | diagnosis: the name of the physician, the name of the patient, | ||||||
24 | the birthdate of the patient, the patient's age at the onset of | ||||||
25 | diabetes, the patient's birth weight, the patient's blood sugar | ||||||
26 | level at the onset of diabetes, any family history of diabetes |
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1 | of any type, and any other pertinent medical history of the | ||||||
2 | patient. Clinical laboratories performing glycosylated | ||||||
3 | hemoglobin tests in this State as of the effective date of this | ||||||
4 | amendatory Act of the 96th General Assembly for patients with | ||||||
5 | diabetes mellitus with onset before 12 months of age must | ||||||
6 | report the results of each test that the laboratory performs to | ||||||
7 | the Department within 30 days after performing such test. | ||||||
8 | (d) The Department shall create for dissemination to | ||||||
9 | physicians, healthcare providers, and clinical laboratories | ||||||
10 | performing glycosylated hemoglobin tests for patients with | ||||||
11 | monogenic neonatal diabetes mellitus a consent form. The | ||||||
12 | physician, healthcare provider, or laboratory shall obtain the | ||||||
13 | informed consent of the patient to the disclosure of the | ||||||
14 | patient's information. At initial consultation, the physician, | ||||||
15 | healthcare provider, or laboratory representative shall | ||||||
16 | provide the patient with a copy of the consent form and orally | ||||||
17 | review the form together with the patient in order to obtain | ||||||
18 | the informed consent of the patient and the physician's, or | ||||||
19 | healthcare provider's, or laboratory's agreement to | ||||||
20 | participate in the pilot program. A copy of the informed | ||||||
21 | consent document, signed and dated by the client and by the | ||||||
22 | physician, healthcare provider, or laboratory representative | ||||||
23 | must be kept in each client's chart. The consent form shall | ||||||
24 | contain the following: | ||||||
25 | (1) an explanation of the pilot program's purpose and | ||||||
26 | protocol; |
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1 | (2) an explanation of the privacy provisions set forth | ||||||
2 | in subsections (f) and (g) of this Section; and | ||||||
3 | (3) signature lines for the physician, healthcare | ||||||
4 | provider, or laboratory representative and for the patient | ||||||
5 | to indicate in writing their agreement to participate in | ||||||
6 | the pilot program. | ||||||
7 | (e) The Department shall allow access of the registry to | ||||||
8 | neonatal diabetes mellitus research institutions participating | ||||||
9 | in the pilot program. The Department and the participating | ||||||
10 | neonatal diabetes mellitus research institution shall do the | ||||||
11 | following: | ||||||
12 | (1) compile results submitted under subsection (c) of
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13 | this Section in order to track: | ||||||
14 | (A) the prevalence and incidence of monogenic | ||||||
15 | neonatal diabetes mellitus among
people tested in this | ||||||
16 | State; | ||||||
17 | (B) the level of control the patients in each
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18 | demographic group exert over the monogenic neonatal | ||||||
19 | diabetes mellitus; | ||||||
20 | (C) the trends of new diagnoses of monogenic | ||||||
21 | neonatal diabetes
mellitus in this State; and | ||||||
22 | (D) the health care costs associated with
diabetes | ||||||
23 | mellitus; and | ||||||
24 | (2) promote discussion and public information
programs | ||||||
25 | regarding monogenic neonatal diabetes mellitus. | ||||||
26 | (f) Reports, records, and information obtained under this |
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1 | Section are confidential, privileged, not subject to | ||||||
2 | disclosure, and
not subject to subpoena and may not otherwise | ||||||
3 | be released or made
public except as provided by this Section. | ||||||
4 | The reports, records, and
information obtained under this | ||||||
5 | Section are for the confidential use of
the Department and the | ||||||
6 | participating neonatal diabetes mellitus research institutions | ||||||
7 | and the persons or public or private entities that the | ||||||
8 | Department determine are necessary to carry out the intent of | ||||||
9 | this Section.
Medical or epidemiological information may be | ||||||
10 | released as follows: | ||||||
11 | (1) for statistical purposes in a manner that prevents
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12 | identification of individuals, health care facilities, | ||||||
13 | clinical
laboratories, or health care practitioners; | ||||||
14 | (2) with the consent of each person identified in the
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15 | information; or | ||||||
16 | (3) to promote diabetes mellitus research, including
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17 | release of information to other diabetes registries and | ||||||
18 | appropriate
State and federal agencies, under rules | ||||||
19 | adopted by the Department to
ensure confidentiality as | ||||||
20 | required by State and federal laws. | ||||||
21 | (g) An employee of this State or a participating neonatal | ||||||
22 | diabetes mellitus research institution may not testify in a | ||||||
23 | civil, criminal, special, or other proceeding as to the | ||||||
24 | existence or contents of records, reports, or information | ||||||
25 | concerning an individual whose medical records have been used | ||||||
26 | in
submitting data required under this Section unless the |
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1 | individual
consents in advance. | ||||||
2 | (h) Not later than December 1, 2012, the Department shall | ||||||
3 | submit a report to the General Assembly regarding the pilot | ||||||
4 | program that includes the following: | ||||||
5 | (1) an evaluation of the effectiveness of the pilot
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6 | program; and | ||||||
7 | (2) a recommendation to continue, expand, or eliminate
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8 | the pilot program. | ||||||
9 | (i) The Department shall adopt rules to implement the pilot | ||||||
10 | program, including rules to govern the format and method of | ||||||
11 | collecting glycosylated hemoglobin data, in accordance with | ||||||
12 | the Illinois Administrative Procedure Act. | ||||||
13 | (j) This Section is repealed on December 31, 2012.
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14 | Section 99. Effective date. This Act takes effect upon | ||||||
15 | becoming law.
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