Public Act 096-0395
 
HB2481 Enrolled LRB096 05834 RPM 15914 b

    AN ACT concerning State government, which may be referred
to as Lilly's Law.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    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)
    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
    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
        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
    identification of individuals, health care facilities,
    clinical laboratories, or health care practitioners;
        (2) with the consent of each person identified in the
    information; or
        (3) to promote diabetes mellitus research, including
    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
    program; and
        (2) a recommendation to continue, expand, or eliminate
    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.
 
    Section 99. Effective date. This Act takes effect upon
becoming law.