Rep. Nabeela Syed

Filed: 2/28/2024

 

 


 

 


 
10300HB4472ham001LRB103 36317 AWJ 70128 a

1
AMENDMENT TO HOUSE BILL 4472

2    AMENDMENT NO. ______. Amend House Bill 4472 by replacing
3everything after the enacting clause with the following:
 
4    "Section 1. Short title. This Act may be cited as the
5Health Care Availability and Access Board Act.
 
6    Section 5. Definitions. In this Act:
7    "Biologic" means a drug that is produced or distributed in
8accordance with a biologics license application approved under
942 U.S.C. 262(k)(3).
10    "Biosimilar" means a drug that is produced or distributed
11in accordance with a biologics license application approved
12under 42 U.S.C. 262(k)(3).
13    "Board" means the Health Care Availability and Access
14Board.
15    "Brand name drug" means a drug that is produced or
16distributed in accordance with an original new drug

 

 

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1application approved under 21 U.S.C. 355(c). "Brand name drug"
2does not include an authorized generic drug as defined by 42
3CFR 447.502.
4    "Council" means the Health Care Availability and Access
5Stakeholder Council.
6    "Generic drug" means:
7        (1) a retail drug that is marketed or distributed in
8    accordance with an abbreviated new drug application,
9    approved under 21 U.S.C. 355(j);
10        (2) an authorized generic drug as defined by 42 CFR
11    447.502; or
12        (3) a drug that entered the market before 1962 that
13    was not originally marketed under a new drug application.
14    "Manufacturer" means an entity that:
15        (1) owns the patent to a prescription drug product; or
16        (2) enters into a lease with another manufacturer to
17    market and distribute a prescription drug product under
18    the entity's own name;
19        (3) is the labeled entity of the generic product at
20    the point of manufacture; and
21        (4) sets or changes the wholesale acquisition cost of
22    the prescription drug product it manufactures or markets.
23    "Prescription drug product" means a brand name drug, a
24generic drug, a biologic, or a biosimilar.
 
25    Section 10. Health Care Availability and Access Board.

 

 

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1    (a) There is established a Health Care Availability and
2Access Board. The purpose of the Board is to protect State
3residents, State and local governments, commercial health
4plans, health care providers, pharmacies licensed in the
5State, and other stakeholders within the health care system
6from the high costs of prescription drug products. The Board
7is a public body and is an instrumentality of the State. The
8Board is an independent unit of State government. The exercise
9by the Board of its authority under this Act is an essential
10function.
11    (b)(1) The 5 members of the Board and 3 alternate members
12shall be appointed by the Governor with the advice and consent
13of the Senate.
14    (2) The Board membership must include individuals with
15demonstrated expertise in health care economics,
16pharmaceutical markets, and clinical medicine. A member or an
17alternate member may not be an employee of, a Board member of,
18or a consultant to a manufacturer or trade association for
19manufacturers.
20    (3) Any conflict of interest, including whether the
21individual has an association that has the potential to bias
22or has the appearance of biasing an individual's decision in
23matters related to the Board or the conduct of the Board's
24activities, including a financial or personal association,
25shall be considered and disclosed when appointing members and
26alternate members to the Board.

 

 

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1    (c) The term of a member or an alternate member is 5 years,
2except that the terms of the initial members and alternate
3members shall be staggered as required by the terms provided
4for members in Section 55. Initial Board members shall be
5appointed within 4 months after the effective date of this
6Act. The Board may begin its work if there is a delay in
7appointments to the Health Care Availability and Access
8Stakeholder Council created under Section 20.
9    (d) The Chair shall hire an executive director, general
10counsel, and staff for the Board. Staff of the Board shall
11receive a salary as provided in the budget of the Board. A
12member of the Board: (i) may receive compensation as a member
13of the Board; and (ii) is entitled to reimbursement for
14expenses.
15    (e) A majority of the members of the Board shall
16constitute a quorum for the purposes of conducting the
17business of the Board.
18    (f) Subject to the requirements of this subsection, the
19Board shall meet in open session at least 4 times per year to
20review prescription drug product information. Information
21concerning the location, date, and time of the meeting must be
22made publicly available in accordance with the Open Meetings
23Act, except as otherwise provided in this Section. The Chair
24may cancel or postpone a meeting if there are no prescription
25drug products to review.
26    The Board shall perform the following actions in open

 

 

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1session: (i) deliberations on whether to subject a
2prescription drug product to a cost affordability review under
3subsection (f) of Section 25; and (ii) any vote on whether to
4impose an upper payment limit on purchases, payments, and
5payor reimbursements of prescription drug products in the
6State. The Board may otherwise meet in closed session to
7discuss proprietary data and information.
8    The Board shall provide public notice of each Board
9meeting at least 3 weeks in advance of the meeting. Materials
10for each Board meeting shall be made available to the public at
11least 3 weeks in advance of the meeting. The Board shall
12provide an opportunity for public comment at each open meeting
13of the Board. The Board shall provide the public with the
14opportunity to provide written comments on pending decisions
15of the Board. The Board may allow expert testimony at Board
16meetings, including when the Board meets in closed session.
17    (g)(1) Members of the Board shall recuse themselves from
18decisions related to a prescription drug product if the
19member, or an immediate family member of the member, has
20received or could receive any of the following:
21        (A) a direct financial benefit of any amount deriving
22    from the result or finding of a study or determination by
23    or for the Board; or
24        (B) a financial benefit in an aggregate amount that
25    exceeds $5,000 per year from any person who owns,
26    manufactures, or provides prescription drug products,

 

 

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1    services, or items to be studied by the Board.
2    A disclosure of interests under this paragraph shall
3include the type, nature, and magnitude of the interests of
4the member or the member's immediate family member.
5    As used in this paragraph, "financial benefit" includes
6honoraria, fees, stock, the value of the member's or immediate
7family member's stock holdings, and any direct financial
8benefit deriving from the finding of a review conducted under
9this Act.
10    (2) A conflict of interest shall be disclosed in advance
11of the first open meeting after the conflict is identified or
12within 5 days after the conflict is identified. A conflict of
13interest shall be disclosed by:
14        (A) the Board when hiring Board staff;
15        (B) the appointing authority when appointing members
16    and alternate members to the Board and members to the
17    Council; and
18        (C) the Board when a member of the Board is recused in
19    any final decision resulting from a review of a
20    prescription drug product.
21    (3) A conflict of interest disclosed under this Section
22shall be posted on the website of the Board unless the Chair of
23the Board recuses the member from any final decision resulting
24from a review of a prescription drug product.
25    (4) Members and alternate members of the Board, Board
26staff, and third-party contractors may not accept any gift or

 

 

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1donation of services or property that indicates a potential
2conflict of interest or has the appearance of biasing the work
3of the Board.
 
4    Section 15. Powers and duties of the Board. In addition to
5the powers set forth elsewhere in this Act, the Board may:
6        (1) adopt rules for the implementation of this Act;
7    and
8        (2) enter into a contract with a qualified,
9    independent third party for any service necessary to carry
10    out the powers and duties of the Board.
11    Unless permission is granted by the Board, a third party
12hired by the Board may not release, publish, or otherwise use
13any information to which the third party has access under its
14contract.
 
15    Section 20. Health Care Availability and Access
16Stakeholder Council.
17    (a) The Health Care Availability and Access Stakeholder
18Council is created. The purpose of the Council is to provide
19stakeholder input to assist the Board in making decisions as
20required under this Act. The Council consists of 15 members
21appointed within 4 months after the effective date of this Act
22as follows:
23        (1) 3 members appointed by the Speaker of the House of
24    Representatives;

 

 

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1        (2) 2 members appointed by the Minority Leader of the
2    House of Representatives;
3        (3) 3 members appointed by the President of the
4    Senate;
5        (4) 2 members appointed by the Minority Leader of the
6    Senate; and
7        (5) 5 members appointed by the Governor.
8                (A) 2 members appointed by the Governor shall
9            represent health care providers;
10                (B) 2 members appointed by the Governor shall
11            represent patients and health care consumers; and
12                (C) One member appointed by the Governor shall
13            be a patient living with a rare disease or a
14            current or former caregiver of a patient living
15            with a rare disease.
16    (b) The members of the Council shall have knowledge in one
17or more of the following:
18        (1) the pharmaceutical business model;
19        (2) supply chain business models;
20        (3) the practice of medicine or clinical training;
21        (4) consumer or patient perspectives;
22        (5) clinical and health services research; or
23        (6) the State's health care marketplace.
24    (c) From among the membership of the Council, the Board
25Chair shall appoint one member to be Council Chair.
26    (d) The term of a member is 3 years, except that the

 

 

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1initial members of the Council shall serve staggered terms as
2required by the terms provided for members in Section 55.
3    (e) A member of the Council may not receive compensation
4as a member of the Council, but is entitled to reimbursement
5for travel expenses.
 
6    Section 25. Drug cost affordability review.
7    (a) The Board shall limit its review of prescription drug
8products to those that are:
9        (1) brand name drugs or biologics that, as adjusted
10    annually for inflation in accordance with the Consumer
11    Price Index, have:
12            (A) a wholesale acquisition cost of $60,000 or
13        more per year or course of treatment if less than a
14        year; or
15            (B) a wholesale acquisition cost increase of
16        $3,000 or more in any 12-month period;
17        (2) biosimilar drugs that have a wholesale acquisition
18    cost that is not at least 20% lower than the referenced
19    brand biologic at the time the biosimilars are launched,
20    and that have been suggested for review by the members of
21    public, medical professionals, and other stakeholders;
22        (3) generic drugs that, as adjusted annually for
23    inflation in accordance with the Consumer Price Index,
24    have a wholesale acquisition cost of at least $100 for a
25    30-day supply or course of treatment less than 30 days and

 

 

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1    which increased by 200% or more during the immediately
2    preceding 12-month period, as determined by the difference
3    between the resulting wholesale acquisition cost and the
4    average of the wholesale acquisition cost reported over
5    the immediately preceding 12 months; and
6        (4) other prescription drug products that may create
7    affordability challenges for the State health care system
8    or patients, including, but not limited to, drugs to
9    address public health emergencies.
10    The Board is not required to identify every prescription
11drug that meets the criteria of this subsection.
12    (b) The Board shall solicit public input on prescription
13drugs thought to be creating affordability challenges that
14meet the parameters of paragraphs (1) through (4) of
15subsection (a). The Board shall determine whether to conduct a
16full affordability review for the proposed prescription drugs
17after compiling preliminary information about the cost of the
18product, patient cost sharing for the product, health plan
19spending on the product, stakeholder input, research and
20development costs of the manufacturer for the drug and the
21extent to which the manufacturer has recouped research and
22development costs, and other information decided by the Board.
23    (c) If the Board conducts a review of the cost and
24affordability of a prescription drug product, the review shall
25determine whether use of the prescription drug product in a
26manner that is fully consistent with the labeling approved by

 

 

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1the United States Food and Drug Administration or standard
2medical practice has led or will lead to affordability
3challenges for the State health care system or high
4out-of-pocket costs for patients.
5    (d) The information to conduct an affordability review may
6include, but is not limited to, any document and research
7related to the manufacturer's selection of the introductory
8price or price increase of the prescription drug product,
9patient assistance program or programs specific to the
10product, estimated or actual manufacturer product price
11concessions in the market, net product cost to State payers,
12and other information as determined by the Board.
13    (e) Failure of a manufacturer to provide the Board with
14the information for an affordability review does not affect
15the authority of the Board to conduct such a review.
16    (f) If the Board finds that the spending on a prescription
17drug product reviewed under this Section has led or will lead
18to an affordability challenge, the Board shall establish an
19upper payment limit considering exceptional administrative
20costs related to the distribution of the drug in the State.
21    (g) The upper payment limit applies to all purchases and
22payor reimbursements of the prescription drug product intended
23for use by individuals in the State, in person, by mail, or by
24other means.
25    (h) Any information submitted to the Board in accordance
26with this Section shall be subject to public inspection only

 

 

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1to the extent allowed under the Freedom of Information Act.
2    (i) This Section may not be construed to prevent a
3manufacturer from marketing a prescription drug product
4approved by the United States Food and Drug Administration
5while the product is under review by the Board.
 
6    Section 30. Protections and other Board considerations.
7    (a) The Board shall examine how an upper payment limit
8would affect a covered entity, as that term is defined in
9Section 340B of the federal Public Health Service Act.
10    (b) In determining whether a drug creates an affordability
11challenge or determining an upper payment limit amount, the
12Board may not, directly or indirectly through a contracted
13entity or other third party, use cost-effectiveness analyses
14that include the cost-per-quality adjusted life year or a
15similar measure to identify subpopulations for which a
16treatment would be less cost-effective due to severity of
17illness, age, or preexisting disability. In addition, for any
18treatment that extends life, if the Board uses
19cost-effectiveness results, the Board must use results that
20weigh the value of all additional lifetime gained equally for
21all patients no matter their severity of illness, age, or
22preexisting disability.
23    (c) An upper payment limit is effective no sooner than 6
24months after it has been announced.
25    (d) Any savings generated by a health plan as a result of

 

 

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1an upper payment limit established by the Board shall be used
2to reduce costs to consumers, prioritizing the reduction of
3out-of-pocket costs for prescription drugs. Each health plan
4shall submit to the Board an annual report describing the
5savings achieved as a result of implementing upper payment
6limits and how those savings were used to reduce costs to
7consumers.
8    (e) The upper payment limit shall not be inclusive of the
9pharmacy dispensing fee, provider administration fee, or
10add-on fee for provider-administered drugs.
11    (f) State licensed independent pharmacies may not be
12reimbursed less than the upper payment limit.
13    (g) The Board shall adopt the Medicare Maximum Fair Price
14as defined in 42 U.S.C. 1320f(c)(3) for a prescription drug as
15the upper payment limit for that prescription drug product
16intended for use by individuals in this State, per subsection
17(g) of Section 25.
 
18    Section 35. Remedies. The Attorney General shall have
19authority to enforce this Act. The Attorney General may pursue
20any available remedy under State law when enforcing this Act.
 
21    Section 40. Appeal of Board decisions.
22    (a) A person aggrieved by a decision of the Board may
23request an appeal of the decision within 30 days after the
24finding of the Board.

 

 

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1    (b) The Board shall hear the appeal and make a final
2decision within 60 days of the hearing.
3    (c) Any person aggrieved by a final decision of the Board
4may petition for judicial review in accordance with the
5provisions of the Administrative Review Law.
 
6    Section 45. Health Care Availability and Access Board
7Fund. The Health Care Availability and Access Board Fund is
8created as a special fund in the State treasury. The Board
9shall be funded by an annual assessment it assesses on all
10manufacturers whose products are sold in the State. All funds
11collected by the Board from the assessments shall be deposited
12into the Fund. The Fund shall be used only to provide funding
13for the Board and for the purposes authorized under this Act,
14including any costs expended by any State agency to implement
15this Act. All interest earned on moneys in the Fund shall be
16credited to the Fund. This Section may not be construed to
17prohibit the Fund from receiving moneys from any other source
18that does not create the appearance of a conflict of interest.
19The Board shall be established using general funds, which
20shall be repaid to the State with the assessments required
21under this Section.
 
22    Section 50. Reports.
23    (a) On or before December 31 of each year, the Board shall
24submit to the General Assembly in accordance with Section 3.1

 

 

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1of the General Assembly Organization Act a report that
2includes:
3        (1) price trends for prescription drug products;
4        (2) the number of prescription drug products that were
5    subject to Board review, including the results of the
6    review and the number and disposition of appeals and
7    judicial reviews of Board decisions;
8        (3) for each medication affected, the patient impact
9    of any upper payment limits that have been established and
10    in effect for more than 12 months before the report is
11    published; and
12        (4) any recommendations the Board may have on further
13    legislation needed to make prescription drug products more
14    affordable in this State.
15    (b) On or before June 1, 2025, the Health Care
16Availability and Access Board shall submit a report to the
17General Assembly concerning the operation of the generic drug
18market in the United States that includes a review of
19physician-administered drugs and considers:
20        (1) the prices of generic drugs on a year-over-year
21    basis;
22        (2) the degree to which generic drug prices affect
23    insurance premiums as reported by health insurers in this
24    State or other states that collect this information;
25        (3) recent and current trends in patient cost sharing
26    for generic drugs;

 

 

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1        (4) the causes and prevalence of generic drug
2    shortages; and
3        (5) any other relevant study questions.
 
4    Section 55. Term expiration.
5    (a) The terms of the initial members and alternate members
6of the Health Care Availability and Access Board shall expire
7as follows:
8        (1) one member and one alternate member in 2028;
9        (2) 2 members and one alternate member in 2029; and
10        (3) 2 members, including the Chair of the Board, and
11    one alternate member in 2030.
12    (b) The terms of the initial members of the Health Care
13Availability and Access Stakeholder Council shall expire as
14follows:
15        (1) 5 members in 2028;
16        (2) 5 members in 2029; and
17        (3) 5 members in 2030.
 
18    Section 97. Severability. If any provision of this Act or
19the application thereof to any person or circumstance is held
20invalid for any reason in a court of competent jurisdiction,
21the invalidity does not affect other provisions or any other
22application of this Act that can be given effect without the
23invalid provision or application, and for this purpose the
24provisions of this Act are declared severable.
 

 

 

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1    Section 900. The State Finance Act is amended by adding
2Section 5.1015 as follows:
 
3    (30 ILCS 105/5.1015 new)
4    Sec. 5.1015. The Health Care Availability and Access Board
5Fund.
 
6    Section 999. Effective date. This Act takes effect upon
7becoming law.".