101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB3268

 

Introduced , by Rep. Sara Feigenholtz

 

SYNOPSIS AS INTRODUCED:
 
305 ILCS 5/5-30.11 new

    Amends the Illinois Public Aid Code. Provides that the Department of Healthcare and Family Services shall not make recommendations or determinations that are more restrictive than federal labeling requirements by the U.S. Food and Drug Administration when making coverage recommendations or determinations affecting medical assistance recipients' access to (1) drugs and biological products for rare diseases and (2) drugs and biological products that are genetically targeted therapies. Requires the Department to implement an open and transparent process that includes clear guidelines for open public comment for the review and study of those drugs and biological products for rare diseases and those that are genetically targeted therapies. Requires the Illinois Drug and Therapeutics Advisory Board (Board) to develop and maintain a list of external experts who (i) possess scientific or medical training with respect to one or more rare diseases and (ii) are qualified to provide advice on rare disease issues and specified topics, including the impact of particular coverage, utilization management, and other relevant drug access policies. Requires the Department to adopt rules to ensure that any provisions of the Illinois Title XIX State Plan that affect medical assistance recipients' access to drugs and biological products for rare diseases are available to the public in a user-friendly and searchable format. Prohibits the Department from disclosing any confidential commercial or trade secret information of a drug manufacturer. Provides that the Board shall not be subject to the 6-month review moratorium for new drugs and shall review new drugs and biological products for rare diseases at the next regularly scheduled meeting. Effective immediately.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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1    AN ACT concerning public aid.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Public Aid Code is amended by
5adding Section 5-30.11 as follows:
 
6    (305 ILCS 5/5-30.11 new)
7    Sec. 5-30.11. Consultation with external experts on rare
8diseases and genetically targeted treatments.
9    (a) When making coverage recommendations or determinations
10affecting recipients access to (i) drugs and biological
11products for rare diseases, as defined in the federal Orphan
12Drug Act of 1983 (Public Law 97-414) and (ii) drugs and
13biological products that are genetically targeted therapies,
14the Department of Healthcare and Family Services shall not make
15recommendations or determinations that are more restrictive
16than federal labeling requirements by the United States Food
17and Drug Administration. In accordance with this Section, the
18Department shall also implement an open and transparent process
19that includes clear guidelines for open public comment for the
20review and study of access to drugs and biological products for
21rare diseases and drugs and biological products that are
22genetically targeted therapies.
23    (b)(1) The Illinois Drug and Therapeutics Advisory Board

 

 

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1shall develop and maintain a list of external experts who:
2        (A) possess scientific or medical training that the
3    Illinois Drug and Therapeutics Advisory Board lacks with
4    respect to one or more rare diseases; and
5        (B) because of their special expertise, are qualified
6    to provide advice on rare disease issues, including topics
7    described in subsection (c).
8    (2) The Illinois Drug and Therapeutics Advisory Board shall
9ensure that opportunities exist, at a time the Board determines
10appropriate, for consultations with external experts on the
11topics described in subsection (c).
12    (3) When appropriate to address a specific question related
13to drugs and biological products for rare diseases or drugs and
14biological products that are genetically targeted therapies,
15the Illinois Drug and Therapeutics Advisory Board may consult
16external experts on issues related to coverage, payment, drug
17utilization review, medication therapy management, prior
18authorization, appeals for coverage, or other topics the Board
19chooses regarding functions performed by the Board.
20    (c) Topics for consultation may include, but are not
21limited to:
22        (1) Rare diseases.
23        (2) The severity of rare diseases.
24        (3) The unmet medical need associated with rare
25    diseases.
26        (4) The impact of particular coverage, utilization

 

 

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1    management, prior authorization, medication therapy
2    management, or other policies on access to rare disease
3    therapies under the Medical Assistance Program.
4        (5) An assessment of the benefits and risks of
5    therapies to treat rare diseases.
6        (6) The impact of particular coverage, utilization
7    management, prior authorization, medication therapy
8    management, or other policies on patients' adherence to the
9    treatment regimen prescribed or otherwise recommended by
10    their physicians.
11        (7) Whether beneficiaries who need treatment from or a
12    consultation with a rare disease specialist have adequate
13    access and, if not, what factors are causing the limited
14    access.
15        (8) The demographics and the clinical description of
16    patient populations.
17    (d) All recommendations made by external experts to the
18Illinois Drug and Therapeutics Advisory Board, including
19recommendations for other drug review processes performed
20under the Medical Assistance Program on an applicable treatment
21of a rare disease shall be:
22        (1) provided in writing to members of the Illinois Drug
23    and Therapeutics Advisory Board;
24        (2) summarized and explained during public hearings;
25    and
26        (3) posted on the Department of Healthcare and Family

 

 

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1    Services' website.
2    (e) The Department of Healthcare and Family Services, in
3consultation with the Illinois Drug and Therapeutics Advisory
4Board and external experts and stakeholders including the
5Illinois Rare Disease Commission, shall adopt rules and
6procedures to ensure that any provisions under the Illinois
7Title XIX State Plan that affect beneficiaries' access to drugs
8and biological products that are for rare diseases or that are
9genetically targeted therapies are available to the public in a
10user-friendly and searchable format. The rules and procedures
11adopted in accordance with this subsection shall include:
12        (1) prior authorization or other utilization
13    management policies;
14        (2) preferred drug list policies; and
15        (3) policies for stakeholder input and public comment
16    at meetings of the Illinois Drug and Therapeutics Advisory
17    Board, which policies shall:
18            (A) include at least 60 days' notice of any
19        proposed policy, and the meeting date, time, and
20        location;
21            (B) comply with the Open Meetings Act; and
22            (C) ensure that the written or verbal public
23        comments received regarding the proposed policies are
24        carefully and systematically considered by the
25        Department of Healthcare and Family Services before
26        the Department develops final policies.

 

 

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1    (f)(1) Except as provided in paragraph (2), nothing in this
2Section shall be construed to alter any laws, regulations, or
3policies concerning the disclosure of any confidential
4commercial or trade secret information obtained by the
5Department of Healthcare and Family Services or the Illinois
6Drug and Therapeutics Advisory Board during a consultation with
7an external expert as provided under this Section.
8    (2) The Department of Healthcare and Family Services shall
9not disclose any confidential commercial or trade secret
10information obtained from an expert consulted under this
11Section unless the Department has received prior written
12consent from the drug manufacturer whose commercial or trade
13secret information was initially disclosed by the expert.
14    Any expert consulted under this Section is subject to the
15same restrictions on disclosure of confidential commercial or
16trade secret information as the Department of Healthcare and
17Family Services and may not disclose information discussed with
18the Department of Healthcare and Family Services unless the
19disclosure is authorized by law.
20    (g) Nothing in this Section shall be construed to:
21        (1) limit the ability of the Department of Healthcare
22    and Family Services to consult with individuals and
23    organizations for purposes other than the purposes
24    described in this Section; and
25        (2) create a legal right for a consultation on any
26    matter, or require the Illinois Drug and Therapeutics

 

 

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1    Advisory Board or the Department of Healthcare and Family
2    Services to meet with any particular expert or stakeholder.
3    (h) The requirements of this Section apply only where the
4consultation with an external expert is undertaken solely under
5the authority of this Section. The requirements of this Section
6do not apply to any consultation with an external expert
7initiated under any other authority.
8    (i) For the purposes of any review of new drugs and
9biological products for rare diseases and drugs and biological
10products that are genetically targeted therapies, the Illinois
11Drug and Therapeutics Advisory Board shall not be subject to
12the 6-month review moratorium for new drugs and shall review
13such drugs at the next regularly scheduled board meeting or no
14later than 90 days after the drug is approved by the United
15States Food and Drug Administration. Prior to a review of any
16new drug, access shall be granted on a case-by-case basis
17according to the federal labeling requirement by the United
18States Food and Drug Administration.
 
19    Section 99. Effective date. This Act takes effect upon
20becoming law.