Full Text of HB2481 096th General Assembly
HB2481enr 96TH GENERAL ASSEMBLY
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| AN ACT concerning State government, which may be referred | 2 |
| to as Lilly's Law.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| 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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| 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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| 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 licensed to practice medicine in all its | 20 |
| branches and other healthcare providers treating a patient in | 21 |
| this State with diabetes mellitus with onset before 12 months | 22 |
| of age shall
report to the Department the following information | 23 |
| from all such cases no more than 30 days after diagnosis: the | 24 |
| name of the physician, the name of the patient, the birthdate | 25 |
| of the patient, the patient's age at the onset of diabetes, the | 26 |
| patient's birth weight, the patient's blood sugar level at the |
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| onset of diabetes, any family history of diabetes of any type, | 2 |
| and any other pertinent medical history of the patient. | 3 |
| Clinical laboratories performing glycosylated hemoglobin tests | 4 |
| in this State as of the effective date of this amendatory Act | 5 |
| of the 96th General Assembly for patients with diabetes | 6 |
| mellitus with onset before 12 months of age must report the | 7 |
| results of each test that the laboratory performs to the | 8 |
| Department within 30 days after performing such test. | 9 |
| (d) The Department shall create for dissemination to | 10 |
| physicians, healthcare providers, and clinical laboratories | 11 |
| performing glycosylated hemoglobin tests for patients with | 12 |
| monogenic neonatal diabetes mellitus a consent form. The | 13 |
| physician, healthcare provider, or laboratory shall obtain the | 14 |
| written informed consent of the patient to the disclosure of | 15 |
| the patient's information. At initial consultation, the | 16 |
| physician, healthcare provider, or laboratory representative | 17 |
| shall provide the patient with a copy of the consent form and | 18 |
| orally review the form together with the patient in order to | 19 |
| obtain the informed consent of the patient and the physician's, | 20 |
| or healthcare provider's, or laboratory's agreement to | 21 |
| participate in the pilot program. A copy of the informed | 22 |
| consent document, signed and dated by the client and by the | 23 |
| physician, healthcare provider, or laboratory representative | 24 |
| must be kept in each client's chart. The consent form shall | 25 |
| contain the following: | 26 |
| (1) an explanation of the pilot program's purpose and |
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| protocol; | 2 |
| (2) an explanation of the privacy provisions set forth | 3 |
| in subsections (f) and (g) of this Section; and | 4 |
| (3) signature lines for the physician, healthcare | 5 |
| provider, or laboratory representative and for the patient | 6 |
| to indicate in writing their agreement to participate in | 7 |
| the pilot program. | 8 |
| (e) The Department shall allow access of the registry to | 9 |
| neonatal diabetes mellitus research institutions participating | 10 |
| in the pilot program. The Department and the participating | 11 |
| neonatal diabetes mellitus research institution shall do the | 12 |
| following: | 13 |
| (1) compile results submitted under subsection (c) of
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| this Section in order to track: | 15 |
| (A) the prevalence and incidence of monogenic | 16 |
| neonatal diabetes mellitus among
people tested in this | 17 |
| State; | 18 |
| (B) the level of control the patients in each
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| demographic group exert over the monogenic neonatal | 20 |
| diabetes mellitus; | 21 |
| (C) the trends of new diagnoses of monogenic | 22 |
| neonatal diabetes
mellitus in this State; and | 23 |
| (D) the health care costs associated with
diabetes | 24 |
| mellitus; and | 25 |
| (2) promote discussion and public information
programs | 26 |
| regarding monogenic neonatal diabetes mellitus. |
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| (f) Reports, records, and information obtained under this | 2 |
| Section are confidential, privileged, not subject to | 3 |
| disclosure, and
not subject to subpoena and may not otherwise | 4 |
| be released or made
public except as provided by this Section. | 5 |
| The reports, records, and
information obtained under this | 6 |
| Section are for the confidential use of
the Department and the | 7 |
| participating neonatal diabetes mellitus research institutions | 8 |
| and the persons or public or private entities that the | 9 |
| Department determine are necessary to carry out the intent of | 10 |
| this Section.
No duty to report under this Section exists if | 11 |
| the patient's legal representative refuses written informed | 12 |
| consent to report. Medical or epidemiological information may | 13 |
| be released as follows: | 14 |
| (1) for statistical purposes in a manner that prevents
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| identification of individuals, health care facilities, | 16 |
| clinical
laboratories, or health care practitioners; | 17 |
| (2) with the consent of each person identified in the
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| information; or | 19 |
| (3) to promote diabetes mellitus research, including
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| release of information to other diabetes registries and | 21 |
| appropriate
State and federal agencies, under rules | 22 |
| adopted by the Department to
ensure confidentiality as | 23 |
| required by State and federal laws. | 24 |
| (g) An employee of this State or a participating neonatal | 25 |
| diabetes mellitus research institution may not testify in a | 26 |
| civil, criminal, special, or other proceeding as to the |
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| existence or contents of records, reports, or information | 2 |
| concerning an individual whose medical records have been used | 3 |
| in
submitting data required under this Section unless the | 4 |
| individual
consents in advance. | 5 |
| (h) Not later than December 1, 2012, the Department shall | 6 |
| submit a report to the General Assembly regarding the pilot | 7 |
| program that includes the following: | 8 |
| (1) an evaluation of the effectiveness of the pilot
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| program; and | 10 |
| (2) a recommendation to continue, expand, or eliminate
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| the pilot program. | 12 |
| (i) The Department shall adopt rules to implement the pilot | 13 |
| program, including rules to govern the format and method of | 14 |
| collecting glycosylated hemoglobin data, in accordance with | 15 |
| the Illinois Administrative Procedure Act. | 16 |
| (j) This Section is repealed on December 31, 2012.
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| Section 99. Effective date. This Act takes effect upon | 18 |
| becoming law.
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