| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
1 | AN ACT concerning State government, which may be referred | |||||||||||||||||||
2 | to as Lilly's Law.
| |||||||||||||||||||
3 | Be it enacted by the People of the State of Illinois,
| |||||||||||||||||||
4 | represented in the General Assembly:
| |||||||||||||||||||
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)
| |||||||||||||||||||
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 diabetes mellitus | |||||||||||||||||||
20 | registry. The Department shall create an electronic registry to | |||||||||||||||||||
21 | track the glycosylated hemoglobin level of each person who has | |||||||||||||||||||
22 | a laboratory test to determine that level performed by a | |||||||||||||||||||
23 | physician or healthcare provider or at a clinical laboratory in |
| |||||||
| |||||||
1 | this State. | ||||||
2 | The goals of the registry are as follows: | ||||||
3 | (1) to help identify new and existing patients with | ||||||
4 | neonatal diabetes; | ||||||
5 | (2) to provide a clearinghouse of information for | ||||||
6 | individuals, their families, and doctors about these | ||||||
7 | syndromes; | ||||||
8 | (3) to keep track of patients with these mutations who | ||||||
9 | are being treated with sulfonylurea drugs and their | ||||||
10 | treatment outcomes; and | ||||||
11 | (4) to help identify new genes responsible for | ||||||
12 | diabetes. | ||||||
13 | (c) Physicians and other healthcare providers treating a | ||||||
14 | patient in this State with diabetes mellitus with onset before | ||||||
15 | 12 months of age shall
report to the Department the following | ||||||
16 | information from all such cases: the name of the physician, the | ||||||
17 | name of the patient, the birthdate of the patient, the | ||||||
18 | patient's age at the onset of diabetes, the patient's birth | ||||||
19 | weight, the patient's blood sugar level at the onset of | ||||||
20 | diabetes, any family history of diabetes of any type, and any | ||||||
21 | other pertinent medical history of the patient. Clinical | ||||||
22 | laboratories performing glycosylated hemoglobin tests in this | ||||||
23 | State as of the effective date of this amendatory Act of the | ||||||
24 | 96th General Assembly for patients with diabetes mellitus with | ||||||
25 | onset before 12 months of age must report the results of each | ||||||
26 | test that the laboratory performs to the Department. The |
| |||||||
| |||||||
1 | physician, healthcare provider, or laboratory shall obtain the | ||||||
2 | informed consent of the patient to the disclosure of the | ||||||
3 | patient's information. | ||||||
4 | (d) The Department shall allow access of the registry to | ||||||
5 | neonatal diabetes mellitus research institutions participating | ||||||
6 | in the pilot program. The Department and the participating | ||||||
7 | neonatal diabetes mellitus research institution shall do the | ||||||
8 | following: | ||||||
9 | (1) compile results submitted under subsection (c) of
| ||||||
10 | this Section in order to track: | ||||||
11 | (A) the prevalence and incidence of diabetes | ||||||
12 | mellitus among
people tested in this State; | ||||||
13 | (B) the level of control the patients in each
| ||||||
14 | demographic group exert over the diabetes mellitus; | ||||||
15 | (C) the trends of new diagnoses of diabetes
| ||||||
16 | mellitus in this State; and | ||||||
17 | (D) the health care costs associated with
diabetes | ||||||
18 | mellitus; and | ||||||
19 | (2) promote discussion and public information
programs | ||||||
20 | regarding diabetes mellitus. | ||||||
21 | (e) Reports, records, and information obtained under this | ||||||
22 | Section are confidential, privileged, not subject to | ||||||
23 | disclosure, and
not subject to subpoena and may not otherwise | ||||||
24 | be released or made
public except as provided by this Section. | ||||||
25 | The reports, records, and
information obtained under this | ||||||
26 | Section are for the confidential use of
the Department and the |
| |||||||
| |||||||
1 | participating neonatal diabetes mellitus research institutions | ||||||
2 | and the persons or public or private entities that the | ||||||
3 | Department determine are necessary to carry out the intent of | ||||||
4 | this Section.
Medical or epidemiological information may be | ||||||
5 | released as follows: | ||||||
6 | (1) for statistical purposes in a manner that prevents
| ||||||
7 | identification of individuals, health care facilities, | ||||||
8 | clinical
laboratories, or health care practitioners; | ||||||
9 | (2) with the consent of each person identified in the
| ||||||
10 | information; or | ||||||
11 | (3) to promote diabetes mellitus research, including
| ||||||
12 | release of information to other diabetes registries and | ||||||
13 | appropriate
State and federal agencies, under rules | ||||||
14 | adopted by the Department to
ensure confidentiality as | ||||||
15 | required by State and federal laws. | ||||||
16 | (f) An employee of this State or a participating neonatal | ||||||
17 | diabetes mellitus research institution may not testify in a | ||||||
18 | civil, criminal, special, or other proceeding as to the | ||||||
19 | existence or contents of records, reports, or information | ||||||
20 | concerning an individual whose medical records have been used | ||||||
21 | in
submitting data required under this Section unless the | ||||||
22 | individual
consents in advance. | ||||||
23 | (g) Not later than December 1, 2012, the Department shall | ||||||
24 | submit a report to the General Assembly regarding the pilot | ||||||
25 | program that includes the following: | ||||||
26 | (1) an evaluation of the effectiveness of the pilot
|
| |||||||
| |||||||
1 | program; and | ||||||
2 | (2) a recommendation to continue, expand, or eliminate
| ||||||
3 | the pilot program. | ||||||
4 | (h) The Department shall adopt rules to implement the pilot | ||||||
5 | program, including rules to govern the format and method of | ||||||
6 | collecting glycosylated hemoglobin data, in accordance with | ||||||
7 | the Illinois Administrative Procedure Act. | ||||||
8 | (i) This Section is repealed on December 31, 2012.
| ||||||
9 | Section 99. Effective date. This Act takes effect upon | ||||||
10 | becoming law.
|