Bill Text: IL HB4472 | 2023-2024 | 103rd General Assembly | Introduced

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Bill Title: Creates the Health Care Availability and Access Board Act. Establishes the Health Care Availability and Access Board to protect State residents, State and local governments, commercial health plans, health care providers, pharmacies licensed in the State, and other stakeholders within the health care system from the high costs of prescription drug products. Contains provisions concerning Board membership and terms; staff for the Board; Board meetings; circumstances under which Board members must recuse themselves; and other matters. Provides that the Board shall perform the following actions in open session: (i) deliberations on whether to subject a prescription drug product to a cost review; and (ii) any vote on whether to impose an upper payment limit on purchases, payments, and payor reimbursements of prescription drug products in the State. Permits the Board to adopt rules to implement the Act and to enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the Board. Creates the Health Care Availability and Access Stakeholder Council to provide stakeholder input to assist the Board in making decisions as required by the Act. Contains provisions concerning Council membership, member terms, and other matters. Provides that the Board shall adopt the federal Medicare Maximum Fair Price as the upper payment limit for a prescription drug product intended for use by individuals in the State. Provides that the Attorney General shall have authority to enforce the Act and may pursue any available remedy under State law when enforcing the Act. Effective 180 days after becoming law.

Spectrum: Partisan Bill (Democrat 28-0)

Status: (Introduced) 2024-10-09 - Added Co-Sponsor Rep. Mary Beth Canty [HB4472 Detail]

Download: Illinois-2023-HB4472-Introduced.html

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103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4472 Introduced , by Rep. Nabeela Syed SYNOPSIS AS INTRODUCED:
New Act
30 ILCS 105/5.1015 new
Creates the Health Care Availability and Access Board Act. Establishes the Health Care Availability and Access Board to protect State residents, State and local governments, commercial health plans, health care providers, pharmacies licensed in the State, and other stakeholders within the health care system from the high costs of prescription drug products. Contains provisions concerning Board membership and terms; staff for the Board; Board meetings; circumstances under which Board members must recuse themselves; and other matters. Provides that the Board shall perform the following actions in open session: (i) deliberations on whether to subject a prescription drug product to a cost review; and (ii) any vote on whether to impose an upper payment limit on purchases, payments, and payor reimbursements of prescription drug products in the State. Permits the Board to adopt rules to implement the Act and to enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the Board. Creates the Health Care Availability and Access Stakeholder Council to provide stakeholder input to assist the Board in making decisions as required by the Act. Contains provisions concerning Council membership, member terms, and other matters. Provides that the Board shall adopt the federal Medicare Maximum Fair Price as the upper payment limit for a prescription drug product intended for use by individuals in the State. Requires the Attorney General to enforce the Act. Effective 180 days after becoming law.
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A BILL FOR
HB4472 LRB103 36317 CES 67585 b
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the Health
Care Availability and Access Board Act.
Section 5. Definitions. In this Act:
"Biologic" means a drug that is produced or distributed in
accordance with a biologics license application approved under
42 U.S.C. 447.502.
"Biosimilar" means a drug that is produced or distributed
in accordance with a biologics license application approved
under 42 U.S.C. 262(k)(3).
"Board" means the Health Care Availability and Access
Board.
"Brand name drug" means a drug that is produced or
distributed in accordance with an original new drug
application approved under 21 U.S.C. 355(c). "Brand name drug"
does not include an authorized generic drug as defined by 42
CFR 447.502.
"Council" means the Health Care Availability and Access
Stakeholder Council.
"Generic drug" means:
(1) a retail drug that is marketed or distributed in

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accordance with an abbreviated new drug application,
approved under 21 U.S.C. 355(j);
(2) an authorized generic drug as defined by 42 CFR
447.502; or
(3) a drug that entered the market before 1962 that
was not originally marketed under a new drug application.
"Manufacturer" means an entity that:
(1) owns the patent to a prescription drug product; or
(2) enters into a lease with another manufacturer to
market and distribute a prescription drug product under
the entity's own name;
(3) is the labeled entity of the generic product at
the point of manufacture; and
(4) sets or changes the wholesale acquisition cost of
the prescription drug product it manufactures or markets.
"Prescription drug product" means a brand name drug, a
generic drug, a biologic, or a biosimilar.
Section 10. Health Care Availability and Access Board.
(a) There is established a Health Care Availability and
Access Board. The purpose of the Board is to protect State
residents, State and local governments, commercial health
plans, health care providers, pharmacies licensed in the
State, and other stakeholders within the health care system
from the high costs of prescription drug products. The Board
is a public body and is an instrumentality of the State. The

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Board is an independent unit of State government. The exercise
by the Board of its authority under this Act is an essential
function.
(b)(1) The 5 members of the Board and 3 alternate members
shall be appointed by the Governor with the advice and consent
of the Senate.
(2) The Board membership must include individuals with
demonstrated expertise in health care economics,
pharmaceutical market, and clinical medicine. A member or an
alternate member may not be an employee of, a Board member of,
or a consultant to a manufacturer or trade association for
manufacturers.
(3) Any conflict of interest, including whether the
individual has an association, including a financial or
personal association, that has the potential to bias or has
the appearance of biasing an individual's decision in matters
related to the Board or the conduct of the Board's activities,
shall be considered and disclosed when appointing members and
alternate members to the Board.
(c) The term of a member or an alternate member is 5 years,
except that the terms of the initial members and alternate
members shall be staggered as required by the terms provided
for members in Section 55. Initial Board members shall be
appointed within 4 months after the effective date of this
Act. The Board may begin its work if there is a delay in
appointments to the Health Care Availability and Access

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Stakeholder Council created under Section 20.
(d) The Chair shall hire an executive director, general
counsel, and staff for the Board. Staff of the Board shall
receive a salary as provided in the budget of the Board. A
member of the Board: (i) may receive compensation as a member
of the Board; and (ii) is entitled to reimbursement for
expenses.
(e) A majority of the members of the Board shall
constitute a quorum for the purposes of conducting the
business of the Board.
(f) Subject to the requirements of this subsection, the
Board shall meet in open session at least 4 times per year to
review prescription drug product information. Information
concerning the location, date, and time of the meeting must be
made publicly available in accordance with the Open Meetings
Act. The Chair may cancel or postpone a meeting if there are no
prescription drug products to review.
The Board shall perform the following actions in open
session: (i) deliberations on whether to subject a
prescription drug product to a cost review under subsection
(f) of Section 25; and (ii) any vote on whether to impose an
upper payment limit on purchases, payments, and payor
reimbursements of prescription drug products in the State. The
Board may otherwise meet in closed session to discuss
proprietary data and information.
The Board shall provide public notice of each Board

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meeting at least 3 weeks in advance of the meeting. Materials
for each Board meeting shall be made available to the public at
least 3 weeks in advance of the meeting. The Board shall
provide an opportunity for public comment at each open meeting
of the Board. The Board shall provide the public with the
opportunity to provide written comments on pending decisions
of the Board. The Board may allow expert testimony at Board
meetings, including when the Board meets in closed session.
(g)(1) Members of the Board shall recuse themselves from
decisions related to a prescription drug product if the
member, or an immediate family member of the member, has
received or could receive any of the following:
(A) a direct financial benefit of any amount deriving
from the result or finding of a study or determination by
or for the Board; or
(B) a financial benefit from any person who owns,
manufactures, or provides prescription drug products,
services, or items to be studied by the Board that in the
aggregate exceeds $5,000 per year.
A disclosure of interests under this paragraph shall
include the type, nature, and magnitude of the interests of
the member or his or her immediate family member involved.
For the purposes of this paragraph, "financial benefit"
includes honoraria, fees, stock, the value of the member's or
immediate family member's stock holdings, and any direct
financial benefit deriving from the finding of a review

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conducted under this Act.
(2) A conflict of interest shall be disclosed in advance
of the first open meeting after the conflict is identified or
within 5 days after the conflict is identified. A conflict of
interest shall be disclosed by:
(A) the Board when hiring Board staff;
(B) the appointing authority when appointing members
and alternate members to the Board and members to the
Council; and
(C) the Board when a member of the Board is recused in
any final decision resulting from a review of a
prescription drug product.
(3) A conflict of interest disclosed under this Section
shall be posted on the website of the Board unless the Chair of
the Board recuses the member from any final decision resulting
from a review of a prescription drug product.
(4) Members and alternate members of the Board, Board
staff, and third-party contractors may not accept any gift or
donation of services or property that indicates a potential
conflict of interest or has the appearance of biasing the work
of the Board.
Section 15. Powers and duties of the Board. In addition to
the powers set forth elsewhere in this Act, the Board may:
(1) adopt rules for the implementation of this Act;
and

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(2) enter into a contract with a qualified,
independent third party for any service necessary to carry
out the powers and duties of the Board.
Unless permission is granted by the Board, a third party
hired by the Board may not release, publish, or otherwise use
any information to which the third party has access under its
contract.
Section 20. Health Care Availability and Access
Stakeholder Council.
(a) The Health Care Availability and Access Stakeholder
Council is created. The purpose of the Council is to provide
stakeholder input to assist the Board in making decisions as
required under this Act. The Council consists of 15 members
appointed within 4 months after the effective date of this Act
as follows:
(1) 3 members appointed by the Speaker of the House of
Representatives;
(2) 2 members appointed by the Minority Leader of the
House of Representatives;
(3) 3 members appointed by the President of the
Senate;
(4) 2 members appointed by the Minority Leader of the
Senate; and
(5) 5 members appointed by the Governor.
(b) The members of the Council shall have knowledge in one

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or more of the following:
(1) the pharmaceutical business model;
(2) supply chain business models;
(3) the practice of medicine or clinical training;
(4) consumer or patient perspectives;
(5) clinical and health services research; or
(6) the State's health care marketplace.
(c) From among the membership of the Council, the Board
Chair shall appoint one member to be Council Chair.
(d) The term of a member is 3 years, except that the
initial members of the Council shall serve staggered terms as
required by the terms provided for members in Section 55.
(e) A member of the Council may not receive compensation
as a member of the Council, but is entitled to reimbursement
for travel expenses.
Section 25. Drug cost affordability review.
(a) The Board shall limit its review of prescription drug
products to those that are:
(1) brand name drugs or biologics that, as adjusted
annually for inflation in accordance with the Consumer
Price Index, have:
(A) a wholesale acquisition cost of $60,000 or
more per year or course of treatment if less than a
year; or
(B) a wholesale acquisition cost increase of

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$3,000 or more in any 12-month period;
(2) biosimilar drugs that have a wholesale acquisition
cost that is not at least 20% lower than the referenced
brand biologic at the time the biosimilars are launched,
and that have been suggested for review by the members of
public, medical professionals, and other stakeholders;
(3) generic drugs that, as adjusted annually for
inflation in accordance with the Consumer Price Index,
have a wholesale acquisition cost of at least $100 for a
30-day supply or course of treatment less than 30 days and
which increased by 200% or more during the immediately
preceding 12-month period, as determined by the difference
between the resulting wholesale acquisition cost and the
average of the wholesale acquisition cost reported over
the immediately preceding 12 months; and
(4) other prescription drug products that may create
affordability challenges for the State health care system
or patients, including, but not limited to, drugs to
address public health emergencies.
The Board is not required to identify every drug to
identify every prescription drug that meets the criteria of
this subsection.
(b) The Board shall solicit public input on prescription
drugs thought to be creating affordability challenges that
meet the parameters of paragraphs (1) through (4) of
subsection (a). The Board shall determine whether to conduct a

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full affordability review for the proposed prescription drugs
after compiling preliminary information about the cost of the
product, patient cost sharing for the product, health plan
spending on the product, stakeholder input, and other
information decided by the Board.
(c) If the Board conducts a review of the cost and
affordability of a prescription drug product, the review shall
determine whether use of the prescription drug product that is
fully consistent with the labeling approved by the United
States Food and Drug Administration or standard medical
practice has led or will lead to affordability challenges for
the State health care system or high out-of-pocket costs for
patients.
(d) The information to conduct an affordability review may
include, but is not limited to, any document and research
related to the manufacturer's selection of the introductory
price or price increase of the prescription drug product,
patient assistance program or programs specific to the
product, estimated or actual manufacturer product price
concessions in the market, net product cost to State payers,
and other information as determined by the Board.
(e) Failure of a manufacturer to provide the Board with
the information for an affordability review does not affect
the authority of the Board to conduct such a review.
(f) If the Board finds that the spending on a prescription
drug product reviewed under this Section has led or will lead

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to an affordability challenge, the Board shall establish an
upper payment limit considering exceptional administrative
costs related to the distribution of the drug in the State.
(g) The upper payment limit applies to all purchases and
payor reimbursements of the prescription drug product intended
for use by individuals in the State, in person, by mail, or by
other means.
(h) Any information submitted to the Board in accordance
with this Section shall be subject to public inspection only
to the extent allowed under the Freedom of Information Act.
(i) This Section may not be construed to prevent a
manufacturer from marketing a prescription drug product
approved by the United States Food and Drug Administration
while the product is under review by the Board.
Section 30. Protections and other Board considerations.
(a) The Board shall examine how an upper payment limit
would affect 340B providers.
(b) In determining whether a drug creates an affordability
challenge or determining an upper payment limit amount, the
Board may not use cost-effectiveness analyses that include the
cost-per-quality adjusted life year or a similar measure to
identify subpopulations for which a treatment would be less
cost-effective due to severity of illness, age, or preexisting
disability. In addition, for any treatment that extends life,
if the Board uses cost-effectiveness results, the Board must

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use results that weigh the value of all additional lifetime
gained equally for all patients no matter their severity of
illness, age, or preexisting disability.
(c) An upper payment limit is effective no sooner than 6
months after it has been announced.
(d) State-regulated health plans shall inform the Board of
how any upper payment limit-related cost savings are directed
to the benefit of enrollees, with a priority on enrollee cost
sharing.
(e) The upper payment limit shall not be inclusive of the
pharmacy dispensing fee or provider administration fee.
(f) State licensed independent pharmacies may not be
reimbursed less than the upper payment limit.
(g) The Board shall adopt the Medicare Maximum Fair Price
as defined in 42 U.S.C. 1320f(c)(3) for a prescription drug as
the upper payment limit for that prescription drug product
intended for use by individuals in this State, per subsection
(g) of Section 25.
Section 35. Remedies. The Attorney General shall have
authority to enforce this Act. The Attorney General may pursue
any available remedy under State law when enforcing this Act.
Section 40. Appeal of Board decisions.
(a) A person aggrieved by a decision of the Board may
request an appeal of the decision within 30 days after the

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finding of the Board.
(b) The Board shall hear the appeal and make a final
decision within 60 days of the hearing.
(c) Any person aggrieved by a final decision of the Board
may petition for judicial review in accordance with the
provisions of the Administrative Review Law.
Section 45. Health Care Availability and Access Board
Fund. The Health Care Availability and Access Board Fund is
created as a special fund in the State treasury. The Board
shall be funded by an annual assessment on all manufacturers
whose products are sold in the State. All funds collected by
the Board from the assessments shall be deposited into the
Fund. The Fund shall be used only to provide funding for the
Board and for the purposes authorized under this Act,
including any costs expended by any State agency to implement
this Act. All interest earned on moneys in the Fund shall be
credited to the Fund. This Section may not be construed to
prohibit the Fund from receiving moneys from any other source
that does not create the appearance of a conflict of interest.
The Board shall be established using general funds, which
shall be repaid to the State with the assessments required
under this Section.
Section 50. Reports.
(a) On or before December 31 of each year, the Board shall

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submit to the General Assembly a report that includes:
(1) price trends for prescription drug products;
(2) the number of prescription drug products that were
subject to Board review, including the results of the
review and the number and disposition of appeals and
judicial reviews of Board decisions; and
(3) any recommendations the Board may have on further
legislation needed to make prescription drug products more
affordable in this State.
(b) On or before June 1, 2025, the Health Care
Availability and Access Board shall submit a report to the
General Assembly about the operation of the generic drug
market in the United States that includes a review of
physician-administered drugs and considers:
(1) the prices of generic drugs on a year-over-year
basis;
(2) the degree to which generic drug prices affect
insurance premiums as reported by health insurers in this
State or other states that collect this information;
(3) recent and current trends in patient cost sharing
for generic drugs;
(4) the causes and prevalence of generic drug
shortages; and
(5) any other relevant study questions.
Section 55. Term expiration.

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(a) The terms of the initial members and alternate members
of the Health Care Availability and Access Board shall expire
as follows:
(1) one member and one alternate member in 2028;
(2) 2 members and one alternate member in 2029; and
(3) 2 members, including the Chair of the Board, and
one alternate member in 2030.
(b) The terms of the initial members of the Health Care
Availability and Access Stakeholder Council shall expire as
follows:
(1) 5 members in 2028;
(2) 5 members in 2029; and
(3) 5 members in 2030.
Section 97. Severability. If any provision of this Act or
the application thereof to any person or circumstance is held
invalid for any reason in a court of competent jurisdiction,
the invalidity does not affect other provisions or any other
application of this Act that can be given effect without the
invalid provision or application, and for this purpose the
provisions of this Act are declared severable.
Section 900. The State Finance Act is amended by adding
Section 5.1015 as follows:
(30 ILCS 105/5.1015 new)

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Sec. 5.1015. The Health Care Availability and Access Board
Fund.