Full Text of HB4472 103rd General Assembly
HB4472ham001 103RD GENERAL ASSEMBLY | Rep. Nabeela Syed Filed: 2/28/2024 | | 10300HB4472ham001 | | LRB103 36317 AWJ 70128 a |
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| 1 | | AMENDMENT TO HOUSE BILL 4472
| 2 | | AMENDMENT NO. ______. Amend House Bill 4472 by replacing | 3 | | everything after the enacting clause with the following: | 4 | | "Section 1. Short title. This Act may be cited as the | 5 | | Health Care Availability and Access Board Act. | 6 | | Section 5. Definitions. In this Act: | 7 | | "Biologic" means a drug that is produced or distributed in | 8 | | accordance with a biologics license application approved under | 9 | | 42 U.S.C. 262(k)(3). | 10 | | "Biosimilar" means a drug that is produced or distributed | 11 | | in accordance with a biologics license application approved | 12 | | under 42 U.S.C. 262(k)(3). | 13 | | "Board" means the Health Care Availability and Access | 14 | | Board. | 15 | | "Brand name drug" means a drug that is produced or | 16 | | distributed in accordance with an original new drug |
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| 1 | | application approved under 21 U.S.C. 355(c). "Brand name drug" | 2 | | does not include an authorized generic drug as defined by 42 | 3 | | CFR 447.502. | 4 | | "Council" means the Health Care Availability and Access | 5 | | Stakeholder 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 | 24 | | generic 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 | 2 | | Access Board. The purpose of the Board is to protect State | 3 | | residents, State and local governments, commercial health | 4 | | plans, health care providers, pharmacies licensed in the | 5 | | State, and other stakeholders within the health care system | 6 | | from the high costs of prescription drug products. The Board | 7 | | is a public body and is an instrumentality of the State. The | 8 | | Board is an independent unit of State government. The exercise | 9 | | by the Board of its authority under this Act is an essential | 10 | | function. | 11 | | (b)(1) The 5 members of the Board and 3 alternate members | 12 | | shall be appointed by the Governor with the advice and consent | 13 | | of the Senate. | 14 | | (2) The Board membership must include individuals with | 15 | | demonstrated expertise in health care economics, | 16 | | pharmaceutical markets, and clinical medicine. A member or an | 17 | | alternate member may not be an employee of, a Board member of, | 18 | | or a consultant to a manufacturer or trade association for | 19 | | manufacturers. | 20 | | (3) Any conflict of interest, including whether the | 21 | | individual has an association that has the potential to bias | 22 | | or has the appearance of biasing an individual's decision in | 23 | | matters related to the Board or the conduct of the Board's | 24 | | activities, including a financial or personal association, | 25 | | shall be considered and disclosed when appointing members and | 26 | | alternate members to the Board. |
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| 1 | | (c) The term of a member or an alternate member is 5 years, | 2 | | except that the terms of the initial members and alternate | 3 | | members shall be staggered as required by the terms provided | 4 | | for members in Section 55. Initial Board members shall be | 5 | | appointed within 4 months after the effective date of this | 6 | | Act. The Board may begin its work if there is a delay in | 7 | | appointments to the Health Care Availability and Access | 8 | | Stakeholder Council created under Section 20. | 9 | | (d) The Chair shall hire an executive director, general | 10 | | counsel, and staff for the Board. Staff of the Board shall | 11 | | receive a salary as provided in the budget of the Board. A | 12 | | member of the Board: (i) may receive compensation as a member | 13 | | of the Board; and (ii) is entitled to reimbursement for | 14 | | expenses. | 15 | | (e) A majority of the members of the Board shall | 16 | | constitute a quorum for the purposes of conducting the | 17 | | business of the Board. | 18 | | (f) Subject to the requirements of this subsection, the | 19 | | Board shall meet in open session at least 4 times per year to | 20 | | review prescription drug product information. Information | 21 | | concerning the location, date, and time of the meeting must be | 22 | | made publicly available in accordance with the Open Meetings | 23 | | Act, except as otherwise provided in this Section. The Chair | 24 | | may cancel or postpone a meeting if there are no prescription | 25 | | drug products to review. | 26 | | The Board shall perform the following actions in open |
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| 1 | | session: (i) deliberations on whether to subject a | 2 | | prescription drug product to a cost affordability review under | 3 | | subsection (f) of Section 25; and (ii) any vote on whether to | 4 | | impose an upper payment limit on purchases, payments, and | 5 | | payor reimbursements of prescription drug products in the | 6 | | State. The Board may otherwise meet in closed session to | 7 | | discuss proprietary data and information. | 8 | | The Board shall provide public notice of each Board | 9 | | meeting at least 3 weeks in advance of the meeting. Materials | 10 | | for each Board meeting shall be made available to the public at | 11 | | least 3 weeks in advance of the meeting. The Board shall | 12 | | provide an opportunity for public comment at each open meeting | 13 | | of the Board. The Board shall provide the public with the | 14 | | opportunity to provide written comments on pending decisions | 15 | | of the Board. The Board may allow expert testimony at Board | 16 | | meetings, including when the Board meets in closed session. | 17 | | (g)(1) Members of the Board shall recuse themselves from | 18 | | decisions related to a prescription drug product if the | 19 | | member, or an immediate family member of the member, has | 20 | | received 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 | 3 | | include the type, nature, and magnitude of the interests of | 4 | | the member or the member's immediate family member. | 5 | | As used in this paragraph, "financial benefit" includes | 6 | | honoraria, fees, stock, the value of the member's or immediate | 7 | | family member's stock holdings, and any direct financial | 8 | | benefit deriving from the finding of a review conducted under | 9 | | this Act. | 10 | | (2) A conflict of interest shall be disclosed in advance | 11 | | of the first open meeting after the conflict is identified or | 12 | | within 5 days after the conflict is identified. A conflict of | 13 | | interest 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 | 22 | | shall be posted on the website of the Board unless the Chair of | 23 | | the Board recuses the member from any final decision resulting | 24 | | from a review of a prescription drug product. | 25 | | (4) Members and alternate members of the Board, Board | 26 | | staff, and third-party contractors may not accept any gift or |
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| 1 | | donation of services or property that indicates a potential | 2 | | conflict of interest or has the appearance of biasing the work | 3 | | of the Board. | 4 | | Section 15. Powers and duties of the Board. In addition to | 5 | | the 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 | 12 | | hired by the Board may not release, publish, or otherwise use | 13 | | any information to which the third party has access under its | 14 | | contract. | 15 | | Section 20. Health Care Availability and Access | 16 | | Stakeholder Council. | 17 | | (a) The Health Care Availability and Access Stakeholder | 18 | | Council is created. The purpose of the Council is to provide | 19 | | stakeholder input to assist the Board in making decisions as | 20 | | required under this Act. The Council consists of 15 members | 21 | | appointed within 4 months after the effective date of this Act | 22 | | as 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 | 17 | | or 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 | 25 | | Chair 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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| 1 | | initial members of the Council shall serve staggered terms as | 2 | | required by the terms provided for members in Section 55. | 3 | | (e) A member of the Council may not receive compensation | 4 | | as a member of the Council, but is entitled to reimbursement | 5 | | for travel expenses. | 6 | | Section 25. Drug cost affordability review. | 7 | | (a) The Board shall limit its review of prescription drug | 8 | | products 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 | 11 | | drug that meets the criteria of this subsection. | 12 | | (b) The Board shall solicit public input on prescription | 13 | | drugs thought to be creating affordability challenges that | 14 | | meet the parameters of paragraphs (1) through (4) of | 15 | | subsection (a). The Board shall determine whether to conduct a | 16 | | full affordability review for the proposed prescription drugs | 17 | | after compiling preliminary information about the cost of the | 18 | | product, patient cost sharing for the product, health plan | 19 | | spending on the product, stakeholder input, research and | 20 | | development costs of the manufacturer for the drug and the | 21 | | extent to which the manufacturer has recouped research and | 22 | | development costs, and other information decided by the Board. | 23 | | (c) If the Board conducts a review of the cost and | 24 | | affordability of a prescription drug product, the review shall | 25 | | determine whether use of the prescription drug product in a | 26 | | manner that is fully consistent with the labeling approved by |
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| 1 | | the United States Food and Drug Administration or standard | 2 | | medical practice has led or will lead to affordability | 3 | | challenges for the State health care system or high | 4 | | out-of-pocket costs for patients. | 5 | | (d) The information to conduct an affordability review may | 6 | | include, but is not limited to, any document and research | 7 | | related to the manufacturer's selection of the introductory | 8 | | price or price increase of the prescription drug product, | 9 | | patient assistance program or programs specific to the | 10 | | product, estimated or actual manufacturer product price | 11 | | concessions in the market, net product cost to State payers, | 12 | | and other information as determined by the Board. | 13 | | (e) Failure of a manufacturer to provide the Board with | 14 | | the information for an affordability review does not affect | 15 | | the authority of the Board to conduct such a review. | 16 | | (f) If the Board finds that the spending on a prescription | 17 | | drug product reviewed under this Section has led or will lead | 18 | | to an affordability challenge, the Board shall establish an | 19 | | upper payment limit considering exceptional administrative | 20 | | costs related to the distribution of the drug in the State. | 21 | | (g) The upper payment limit applies to all purchases and | 22 | | payor reimbursements of the prescription drug product intended | 23 | | for use by individuals in the State, in person, by mail, or by | 24 | | other means. | 25 | | (h) Any information submitted to the Board in accordance | 26 | | with this Section shall be subject to public inspection only |
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| 1 | | to the extent allowed under the Freedom of Information Act. | 2 | | (i) This Section may not be construed to prevent a | 3 | | manufacturer from marketing a prescription drug product | 4 | | approved by the United States Food and Drug Administration | 5 | | while 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 | 8 | | would affect a covered entity, as that term is defined in | 9 | | Section 340B of the federal Public Health Service Act. | 10 | | (b) In determining whether a drug creates an affordability | 11 | | challenge or determining an upper payment limit amount, the | 12 | | Board may not, directly or indirectly through a contracted | 13 | | entity or other third party, use cost-effectiveness analyses | 14 | | that include the cost-per-quality adjusted life year or a | 15 | | similar measure to identify subpopulations for which a | 16 | | treatment would be less cost-effective due to severity of | 17 | | illness, age, or preexisting disability. In addition, for any | 18 | | treatment that extends life, if the Board uses | 19 | | cost-effectiveness results, the Board must use results that | 20 | | weigh the value of all additional lifetime gained equally for | 21 | | all patients no matter their severity of illness, age, or | 22 | | preexisting disability. | 23 | | (c) An upper payment limit is effective no sooner than 6 | 24 | | months after it has been announced. | 25 | | (d) Any savings generated by a health plan as a result of |
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| 1 | | an upper payment limit established by the Board shall be used | 2 | | to reduce costs to consumers, prioritizing the reduction of | 3 | | out-of-pocket costs for prescription drugs. Each health plan | 4 | | shall submit to the Board an annual report describing the | 5 | | savings achieved as a result of implementing upper payment | 6 | | limits and how those savings were used to reduce costs to | 7 | | consumers. | 8 | | (e) The upper payment limit shall not be inclusive of the | 9 | | pharmacy dispensing fee, provider administration fee, or | 10 | | add-on fee for provider-administered drugs. | 11 | | (f) State licensed independent pharmacies may not be | 12 | | reimbursed less than the upper payment limit. | 13 | | (g) The Board shall adopt the Medicare Maximum Fair Price | 14 | | as defined in 42 U.S.C. 1320f(c)(3) for a prescription drug as | 15 | | the upper payment limit for that prescription drug product | 16 | | intended for use by individuals in this State, per subsection | 17 | | (g) of Section 25. | 18 | | Section 35. Remedies. The Attorney General shall have | 19 | | authority to enforce this Act. The Attorney General may pursue | 20 | | any 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 | 23 | | request an appeal of the decision within 30 days after the | 24 | | finding of the Board. |
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| 1 | | (b) The Board shall hear the appeal and make a final | 2 | | decision within 60 days of the hearing. | 3 | | (c) Any person aggrieved by a final decision of the Board | 4 | | may petition for judicial review in accordance with the | 5 | | provisions of the Administrative Review Law. | 6 | | Section 45. Health Care Availability and Access Board | 7 | | Fund. The Health Care Availability and Access Board Fund is | 8 | | created as a special fund in the State treasury. The Board | 9 | | shall be funded by an annual assessment it assesses on all | 10 | | manufacturers whose products are sold in the State. All funds | 11 | | collected by the Board from the assessments shall be deposited | 12 | | into the Fund. The Fund shall be used only to provide funding | 13 | | for the Board and for the purposes authorized under this Act, | 14 | | including any costs expended by any State agency to implement | 15 | | this Act. All interest earned on moneys in the Fund shall be | 16 | | credited to the Fund. This Section may not be construed to | 17 | | prohibit the Fund from receiving moneys from any other source | 18 | | that does not create the appearance of a conflict of interest. | 19 | | The Board shall be established using general funds, which | 20 | | shall be repaid to the State with the assessments required | 21 | | under this Section. | 22 | | Section 50. Reports. | 23 | | (a) On or before December 31 of each year, the Board shall | 24 | | submit to the General Assembly in accordance with Section 3.1 |
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| 1 | | of the General Assembly Organization Act a report that | 2 | | includes: | 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 | 16 | | Availability and Access Board shall submit a report to the | 17 | | General Assembly concerning the operation of the generic drug | 18 | | market in the United States that includes a review of | 19 | | physician-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 | 6 | | of the Health Care Availability and Access Board shall expire | 7 | | as 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 | 13 | | Availability and Access Stakeholder Council shall expire as | 14 | | follows: | 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 | 19 | | the application thereof to any person or circumstance is held | 20 | | invalid for any reason in a court of competent jurisdiction, | 21 | | the invalidity does not affect other provisions or any other | 22 | | application of this Act that can be given effect without the | 23 | | invalid provision or application, and for this purpose the | 24 | | provisions of this Act are declared severable. |
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| 1 | | Section 900. The State Finance Act is amended by adding | 2 | | Section 5.1015 as follows: | 3 | | (30 ILCS 105/5.1015 new) | 4 | | Sec. 5.1015. The Health Care Availability and Access Board | 5 | | Fund. | 6 | | Section 999. Effective date. This Act takes effect upon | 7 | | becoming law.". |
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