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Public Act 096-0395 |
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AN ACT concerning State government, which may be referred | ||||
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 | ||||
Duties Law of the
Civil Administrative Code of Illinois is | ||||
amended by adding Section 2310-640 as follows: | ||||
(20 ILCS 2310/2310-640 new)
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Sec. 2310-640. Neonatal Diabetes Mellitus Registry Pilot | ||||
Program. | ||||
(a) In this Section, "neonatal diabetes mellitus research | ||||
institution" means an Illinois academic medical research | ||||
institution that (i) conducts research in the area of diabetes | ||||
mellitus with onset before 12 months of age and (ii) is | ||||
functioning in this capacity as of the effective date of this | ||||
amendatory Act of the 96th General Assembly. | ||||
(b) The Department, subject to appropriation or other funds | ||||
made available for this purpose, shall develop and implement a | ||||
3-year pilot program to create and maintain a monogenic | ||||
neonatal diabetes mellitus registry. The Department shall | ||||
create an electronic registry to track the glycosylated | ||||
hemoglobin level of each person with monogenic neonatal | ||||
diabetes who has a laboratory test to determine that level |
performed by a physician or healthcare provider or at a | ||
clinical laboratory in this State. The Department shall | ||
facilitate collaborations between participating physicians and | ||
other healthcare providers and the Kovler Diabetes Center at | ||
the University of Chicago in order to assist participating | ||
physicians and other healthcare providers with genetic testing | ||
and follow-up care for participating patients. | ||
The goals of the registry are as follows: | ||
(1) to help identify new and existing patients with | ||
neonatal diabetes; | ||
(2) to provide a clearinghouse of information for | ||
individuals, their families, and doctors about these | ||
syndromes; | ||
(3) to keep track of patients with these mutations who | ||
are being treated with sulfonylurea drugs and their | ||
treatment outcomes; and | ||
(4) to help identify new genes responsible for | ||
diabetes. | ||
(c) Physicians licensed to practice medicine in all its | ||
branches and other healthcare providers treating a patient in | ||
this State with diabetes mellitus with onset before 12 months | ||
of age shall
report to the Department the following information | ||
from all such cases no more than 30 days after diagnosis: the | ||
name of the physician, the name of the patient, the birthdate | ||
of the patient, the patient's age at the onset of diabetes, the | ||
patient's birth weight, the patient's blood sugar level at the |
onset of diabetes, any family history of diabetes of any type, | ||
and any other pertinent medical history of the patient. | ||
Clinical laboratories performing glycosylated hemoglobin tests | ||
in this State as of the effective date of this amendatory Act | ||
of the 96th General Assembly for patients with diabetes | ||
mellitus with onset before 12 months of age must report the | ||
results of each test that the laboratory performs to the | ||
Department within 30 days after performing such test. | ||
(d) The Department shall create for dissemination to | ||
physicians, healthcare providers, and clinical laboratories | ||
performing glycosylated hemoglobin tests for patients with | ||
monogenic neonatal diabetes mellitus a consent form. The | ||
physician, healthcare provider, or laboratory shall obtain the | ||
written informed consent of the patient to the disclosure of | ||
the patient's information. At initial consultation, the | ||
physician, healthcare provider, or laboratory representative | ||
shall provide the patient with a copy of the consent form and | ||
orally review the form together with the patient in order to | ||
obtain the informed consent of the patient and the physician's, | ||
or healthcare provider's, or laboratory's agreement to | ||
participate in the pilot program. A copy of the informed | ||
consent document, signed and dated by the client and by the | ||
physician, healthcare provider, or laboratory representative | ||
must be kept in each client's chart. The consent form shall | ||
contain the following: | ||
(1) an explanation of the pilot program's purpose and |
protocol; | ||
(2) an explanation of the privacy provisions set forth | ||
in subsections (f) and (g) of this Section; and | ||
(3) signature lines for the physician, healthcare | ||
provider, or laboratory representative and for the patient | ||
to indicate in writing their agreement to participate in | ||
the pilot program. | ||
(e) The Department shall allow access of the registry to | ||
neonatal diabetes mellitus research institutions participating | ||
in the pilot program. The Department and the participating | ||
neonatal diabetes mellitus research institution shall do the | ||
following: | ||
(1) compile results submitted under subsection (c) of
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this Section in order to track: | ||
(A) the prevalence and incidence of monogenic | ||
neonatal diabetes mellitus among
people tested in this | ||
State; | ||
(B) the level of control the patients in each
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demographic group exert over the monogenic neonatal | ||
diabetes mellitus; | ||
(C) the trends of new diagnoses of monogenic | ||
neonatal diabetes
mellitus in this State; and | ||
(D) the health care costs associated with
diabetes | ||
mellitus; and | ||
(2) promote discussion and public information
programs | ||
regarding monogenic neonatal diabetes mellitus. |
(f) Reports, records, and information obtained under this | ||
Section are confidential, privileged, not subject to | ||
disclosure, and
not subject to subpoena and may not otherwise | ||
be released or made
public except as provided by this Section. | ||
The reports, records, and
information obtained under this | ||
Section are for the confidential use of
the Department and the | ||
participating neonatal diabetes mellitus research institutions | ||
and the persons or public or private entities that the | ||
Department determine are necessary to carry out the intent of | ||
this Section.
No duty to report under this Section exists if | ||
the patient's legal representative refuses written informed | ||
consent to report. Medical or epidemiological information may | ||
be released as follows: | ||
(1) for statistical purposes in a manner that prevents
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identification of individuals, health care facilities, | ||
clinical
laboratories, or health care practitioners; | ||
(2) with the consent of each person identified in the
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information; or | ||
(3) to promote diabetes mellitus research, including
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release of information to other diabetes registries and | ||
appropriate
State and federal agencies, under rules | ||
adopted by the Department to
ensure confidentiality as | ||
required by State and federal laws. | ||
(g) An employee of this State or a participating neonatal | ||
diabetes mellitus research institution may not testify in a | ||
civil, criminal, special, or other proceeding as to the |
existence or contents of records, reports, or information | ||
concerning an individual whose medical records have been used | ||
in
submitting data required under this Section unless the | ||
individual
consents in advance. | ||
(h) Not later than December 1, 2012, the Department shall | ||
submit a report to the General Assembly regarding the pilot | ||
program that includes the following: | ||
(1) an evaluation of the effectiveness of the pilot
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program; and | ||
(2) a recommendation to continue, expand, or eliminate
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the pilot program. | ||
(i) The Department shall adopt rules to implement the pilot | ||
program, including rules to govern the format and method of | ||
collecting glycosylated hemoglobin data, in accordance with | ||
the Illinois Administrative Procedure Act. | ||
(j) This Section is repealed on December 31, 2012.
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Section 99. Effective date. This Act takes effect upon | ||
becoming law.
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