Illinois General Assembly - Full Text of HB5300
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Full Text of HB5300  102nd General Assembly




State of Illinois
2021 and 2022


Introduced 1/31/2022, by Rep. Will Guzzardi - Kathleen Willis, Theresa Mah, Rita Mayfield, Kelly M. Cassidy, et al.


New Act
30 ILCS 105/5.970 new
215 ILCS 5/356z.41

    Creates the Insulin for All Act. Provides that the Department of Public Health shall offer a discount program that allows participants to purchase insulin at a discounted, post-rebate price. Sets forth provisions concerning an insulin urgent-need program. Provides that by July 1, 2022, each manufacturer shall establish procedures to make insulin available to eligible individuals who are in urgent need of insulin or who are in need of access to an affordable insulin supply. Sets forth provisions concerning insulin urgent-need program exceptions, eligibility, forms, applications, claims and reimbursement, copayments, information sheets, navigators, and penalties. Sets forth provisions concerning an insulin patient assistance program and manufacturer responsibilities and process of the patient assistance program. Sets forth provisions concerning dispute resolution, reports, and penalties for insulin programs. Creates the Insulin Assistance Fund. Defines terms. Amends the Illinois Insurance Code. In provisions concerning cost sharing in prescription insulin drugs, provides that an insurer that provides coverage for prescription insulin drugs under the terms of a health coverage plan the insurer offers shall limit the total amount that an insured is required to pay for a 30-day supply of covered prescription insulin drugs at an amount not to exceed $35 (rather than $100). Makes a conforming change in the State Finance Act. Makes other changes. Effective immediately.

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HB5300LRB102 24818 BMS 35502 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 1. Short title. This Act may be cited as the
5Insulin for All Act.
6    Section 5. Definitions. As used in this Act:
7    "Board of Pharmacy" means the State Board of Pharmacy of
8the Department of Financial and Professional Regulation.
9    "Department" means the Department of Public Health.
10    "Diabetes" means:
11        (1) complete insulin deficiency or type 1 diabetes;
12        (2) insulin resistant with partial insulin deficiency
13    or type 2 diabetes; or
14        (3) elevated blood glucose levels induced by pregnancy
15    or gestational diabetes.
16    "Discount program" means a process developed by the
17Department that allows participants to purchase insulin at a
18discounted, post-rebate rate.
19    "Individual with diabetes" means an individual who has
20been diagnosed with diabetes and who uses insulin to treat
22    "Insulin" means a prescription drug that contains insulin.
23    "Manufacturer" means a manufacturer engaged in the



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1manufacturing of insulin that is self-administered on an
2outpatient basis.
3    "Navigator" has the meaning described in Section 1311(i)
4of the Patient Protection and Affordable Care Act, Public Law
5111-148, and further defined through amendments to the Act and
6regulations issued under the Act.
7    "Participant" means a resident of this State who:
8        (1) uses insulin to treat diabetes;
9        (2) does not receive health coverage under the medical
10    assistance program under the Illinois Public Aid Code; and
11        (3) enrolls in the discount program.
12    "Pharmacy" means a pharmacy located in this State.
13    "Prescription drug" means a drug that is required by
14federal or State law or rule to be dispensed only by
15prescription or that is restricted to administration only by
17    "Rebate" means a refund, discount, or other price
18concession that is paid by a pharmaceutical manufacturer to a
19pharmacy benefit manager based on a prescription drug's
20utilization or effectiveness. "Rebate" does not include an
21administrative fee.
22    "Urgent need of insulin" means having readily available
23for use less than a 7-day supply of insulin and in need of
24insulin in order to avoid the likelihood of suffering
25significant health consequences.



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1    Section 10. Insulin discount program.
2    (a) The Department shall offer a discount program that
3allows participants to purchase insulin at a discounted,
4post-rebate price.
5    (b) The discount program shall:
6        (1) provide a participant with a card or electronic
7    document that identifies the participant as eligible for
8    the discount;
9        (2) provide a participant with information about
10    pharmacies that will honor the discount;
11        (3) allow a participant to purchase insulin at a
12    discounted, post-rebate price; and
13        (4) provide a participant with instructions to pursue
14    a reimbursement of the purchase price from the
15    participant's health insurer.
16    (c) The discount program shall charge a price for insulin
17that allows the program to retain only enough of any rebate for
18the insulin to make the State risk pool whole for providing
19discounted insulin to participants.
20    Section 15. Insulin urgent-need program.
21    (a) To be eligible to receive an urgent-need supply of
22insulin under this Section, an individual must attest to:
23        (1) being a resident of this State;
24        (2) not being enrolled in a medical assistance program
25    under the Illinois Public Aid Code;



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1        (3) not being enrolled in prescription drug coverage
2    that limits the total amount of cost sharing that the
3    enrollee is required to pay for a 30-day supply of
4    insulin, including copayments, deductibles, or
5    coinsurance, to $35 or less, regardless of the type or
6    amount of insulin prescribed;
7        (4) not having received an urgent-need supply of
8    insulin through this program within the previous 12
9    months, unless authorized under subsection (n) or (o); and
10        (5) being in urgent need of insulin.
11    (b) The Department shall develop an application form to be
12used by an individual who is in urgent need of insulin. The
13application must ask the individual to attest to the
14eligibility requirements described in subsection (a). The form
15shall be accessible through the Department's website. The
16Department shall also make the form available to pharmacies
17and health care providers who prescribe or dispense insulin,
18hospital emergency departments, urgent care clinics, and
19community health clinics. By submitting a completed, signed,
20and dated application to a pharmacy, the individual attests
21that the information contained in the application is correct.
22    (c) If an individual is in urgent need of insulin, the
23individual may present a completed, signed, and dated
24application form to a pharmacy. The individual must also:
25        (1) have a valid insulin prescription; and
26        (2) present the pharmacist with identification



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1    indicating Illinois residency in the form of a valid
2    Illinois identification card, driver's license, or permit;
3    if the individual in urgent need of insulin is under the
4    age of 18, the individual's parent or legal guardian must
5    provide the pharmacist with proof of residency.
6    (d) Upon receipt of a completed and signed application, a
7pharmacist shall dispense the prescribed insulin in an amount
8that will provide the individual with a 30-day supply. The
9pharmacy shall notify the health care practitioner who issued
10the prescription order no later than 72 hours after the
11insulin is dispensed.
12    (e) A pharmacy may submit to the manufacturer of the
13dispensed insulin product or to the manufacturer's vendor a
14claim for payment that is in accordance with the National
15Council for Prescription Drug Program standards for electronic
16claims processing, unless the manufacturer agrees to send to
17the pharmacy a replacement supply of the same insulin as
18dispensed in the amount dispensed. If the pharmacy submits an
19electronic claim to the manufacturer or the manufacturer's
20vendor, the manufacturer or vendor shall reimburse the
21pharmacy in an amount that covers the pharmacy's acquisition
23    (f) A pharmacy may collect an insulin copayment from an
24individual to cover the pharmacy's costs of processing and
25dispensing in an amount not to exceed $35 for the 30-day supply
26of insulin dispensed.



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1    (g) The pharmacy shall also provide each eligible
2individual with the information sheet described in subsection
3(i) and a list of trained navigators provided by the
4Department for the individual to contact if the individual is
5in need of accessing ongoing insulin coverage options,
6including assistance in:
7        (1) applying for medical assistance;
8        (2) applying for a qualified health plan, subject to
9    open and special enrollment periods;
10        (3) accessing information on providers who participate
11    in prescription drug discount programs, including
12    providers who are authorized to participate in the 340B
13    program under Section 340b of the Public Health Services
14    Act, Section 256b of Title 42 of the United States Code;
15    and
16        (4) accessing insulin manufacturers' patient
17    assistance programs, copayment assistance programs, and
18    other foundation-based programs.
19    (h) A pharmacist shall retain a copy of the application
20form submitted by the individual to the pharmacy for reporting
21and auditing purposes.
22    (i) The Department shall develop an information sheet to
23post on its website and provide a link to the information sheet
24on the board's website for pharmacies, health care
25practitioners, hospital emergency departments, urgent care
26clinics, and community health clinics. The information sheet



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1shall contain:
2        (1) a description of the urgent-need insulin program,
3    including how to access the program;
4        (2) a description of each insulin manufacturer's
5    patient assistance program and cost-sharing assistance
6    program, including contact information on accessing the
7    assistance programs for each manufacturer;
8        (3) information on how to contact a trained navigator
9    for assistance in applying for medical assistance, a
10    qualified health plan, or an insulin manufacturer's
11    patient assistance programs;
12        (4) information on how to contact the Department if a
13    manufacturer determines that an individual is not eligible
14    for the manufacturer's patient assistance program; and
15        (5) notification that an individual in need of
16    assistance may contact their local county social service
17    department for more information or assistance in accessing
18    ongoing affordable insulin options.
19    (j) The Department shall also inform each individual who
20accesses urgent-need insulin under this Section or who
21accesses a manufacturer's patient assistance program that the
22individual may participate in a survey conducted by the
23Department regarding satisfaction with the program. The
24Department shall provide contact information for the
25individual to learn more about the survey and how to
26participate. This information may be included on the



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1information sheet described in subsection (i).
2    (k) The Department shall develop a training program for
3navigators to provide navigators with information and
4resources necessary to assist individuals in accessing
5appropriate long-term insulin options.
6    (l) The Department shall compile a list of navigators who
7have completed the training program and who are available to
8assist individuals in accessing affordable insulin coverage
9options. The list shall be made available through the
10Department's website and to pharmacies and health care
11practitioners who dispense and prescribe insulin.
12    (m) If a navigator assists an individual in accessing an
13insulin manufacturer's patient assistance program, the
14Department, within the available appropriation, shall pay the
15navigator a one-time application assistance bonus of no less
16than $25.
17    (n) If an individual has applied for the medical
18assistance program under the Illinois Public Aid Code but has
19not been determined eligible or has been determined eligible
20but coverage has not become effective, or the individual has
21been determined ineligible for the manufacturer's patient
22assistance program by the manufacturer and the individual has
23requested a review pursuant to subsection (o) of Section 20
24but the panel has not rendered a decision, the individual may
25access urgent-need insulin if the individual is in urgent need
26of insulin as defined in Section 5.



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1    (o) To access an additional 30-day supply of insulin, an
2individual must attest to the pharmacy that the individual
3meets the requirements of subsection (n) and must comply with
4subsection (c).
5    Section 20. Insulin patient assistance program.
6    (a) Each manufacturer shall make a patient assistance
7program available to any individual who meets the requirements
8of this Section. Each manufacturer's patient assistance
9program must meet the requirements of this Section. Each
10manufacturer shall provide the Department with information
11regarding the manufacturer's patient assistance program,
12including contact information for individuals to call for
13assistance in accessing their patient assistance program.
14    (b) A manufacturer's patient assistance program must cover
15every individual who:
16        (1) is an Illinois resident with a valid Illinois
17    identification card or driver's license or permit that
18    indicates Illinois residency; if the individual is under
19    the age of 18, the individual's parent or legal guardian
20    must provide proof of residency;
21        (2) has a family income that is equal to or less than
22    400% of the federal poverty guidelines;
23        (3) is not enrolled in a medical assistance program
24    under the Illinois Public Aid Code;
25        (4) is not eligible to receive health care through a



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1    federally funded program or to receive prescription drug
2    benefits through the Department of Veterans Affairs; and
3        (5) is not enrolled in prescription drug coverage
4    through an individual or group health plan that limits the
5    total amount of cost-sharing that an enrollee is required
6    to pay for a 30-day supply of insulin, including
7    copayments, deductibles, or coinsurance, to $35 or less,
8    regardless of the type or amount of insulin needed.
9    (c) Notwithstanding the requirement in paragraph (4) of
10subsection (b), an individual who is enrolled in Medicare Part
11D is eligible for a manufacturer's patient assistance program
12if the individual has spent $1,000 on prescription drugs in
13the current calendar year and meets the eligibility
14requirements in paragraphs (1), (2), and (3) of subsection
16    (d) An individual who is interested in participating in a
17manufacturer's patient assistance program may apply directly
18to the manufacturer; apply through the individual's health
19care practitioner, if the practitioner participates; or
20contact a trained navigator for assistance in finding a
21long-term insulin supply solution, including assistance in
22applying to a manufacturer's patient assistance program.
23    (e) Upon receipt of an application for the manufacturer's
24patient assistance program, the manufacturer shall process the
25application and determine eligibility. The manufacturer shall
26notify the applicant of the determination of eligibility



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1within 10 business days after receipt of the application. If
2necessary, the manufacturer may request additional information
3from the applicant. If additional information is needed, the
4manufacturer must notify the applicant within 5 business days
5after receipt of the application as to what information is
6being requested. Within 3 business days after receipt of the
7requested additional information, the manufacturer shall
8determine eligibility and notify the applicant of the
9determination. If the individual has been determined to be not
10eligible, the manufacturer must include the reasons for
11denying eligibility in the notification. The individual may
12seek an appeal of the determination in accordance with
13subsection (o).
14    (f) If an individual is determined to be eligible, the
15manufacturer shall provide the individual with an eligibility
16statement or other indication that the individual has been
17determined eligible for the manufacturer's patient assistance
18program. An individual's eligibility is valid for 12 months,
19and is renewable upon a redetermination of eligibility.
20    (g) If the eligible individual has prescription drug
21coverage through an individual or group health plan, the
22manufacturer may determine that the individual's insulin needs
23are better addressed through the use of the manufacturer's
24copayment assistance program, in which case the manufacturer
25shall inform the individual and provide the individual with
26the necessary coupons to submit to a pharmacy. An eligible



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1individual may not be required to pay more than the copayment
2amount specified under subsection (f) of Section 15.
3    (h) The individual shall submit to a pharmacy the
4statement of eligibility provided by the manufacturer under
5subsection (f). Upon receipt of an individual's eligibility
6status, the pharmacy shall submit an order containing the name
7of the insulin product and the daily dosage amount as
8contained in a valid prescription to the product's
10    (i) The pharmacy must include with the order to the
11manufacturer the following information:
12        (1) the pharmacy's name and shipping address;
13        (2) the pharmacy's office telephone number, fax
14    number, e-mail address, and contact name; and
15        (3) any specific days or times when deliveries are not
16    accepted by the pharmacy.
17    (j) Upon receipt of an order from a pharmacy and the
18information described in subsection (i), the manufacturer
19shall send to the pharmacy a 90-day supply of insulin as
20ordered, unless a lesser amount is requested in the order, at
21no charge to the individual or pharmacy.
22    (k) Except as authorized under subsection (l), the
23pharmacy shall provide the insulin to the individual at no
24charge to the individual. The pharmacy may not provide insulin
25received from the manufacturer to any individual other than
26the individual associated with the specific order. The



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1pharmacy may not seek reimbursement for the insulin received
2from the manufacturer or from any third-party payer.
3    (l) The pharmacy may collect a copayment from the
4individual to cover the pharmacy's costs for processing and
5dispensing in an amount not to exceed $35 for each 90-day
6supply if the insulin is sent to the pharmacy.
7    (m) The pharmacy may submit to a manufacturer a reorder
8for an individual if the individual's eligibility statement
9has not expired. Upon receipt of a reorder from a pharmacy, the
10manufacturer must send to the pharmacy an additional 90-day
11supply of the product, unless a lesser amount is requested, at
12no charge to the individual or pharmacy if the individual's
13eligibility statement has not expired.
14    (n) Notwithstanding subsection (j), a manufacturer may
15send the insulin as ordered directly to the individual if the
16manufacturer provides a mail order service option.
17    (o) If an individual disagrees with a manufacturer's
18determination of eligibility under subsection (e), the
19individual may contact the Board of Pharmacy to request the
20use of a 3-person panel to review eligibility. The panel shall
21be composed of 3 members of the board. The individual
22requesting the review shall submit to the board, with the
23request, all documents submitted by the individual to the
24manufacturer. The board shall provide the panel with the
25documents submitted by the individual. The panel shall render
26a decision within 10 business days after receipt of all the



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1necessary documents from the individual. The decision of the
2panel is final.
3    If the panel determines that the individual is eligible,
4the manufacturer shall provide the individual with an
5eligibility statement in accordance with subsection (e).
6    Section 25. Reports.
7    (a) By February 15 of each year, beginning February 15,
82023, each manufacturer shall report to the Board of Pharmacy
9the following:
10        (1) The number of Illinois residents in the preceding
11    calendar year who accessed and received insulin on an
12    urgent-need basis under this Act.
13        (2) The number of Illinois residents in the preceding
14    calendar year who participated in the manufacturer's
15    patient assistance program, including the number of
16    Illinois residents who the manufacturer determined were
17    ineligible for their patient assistance program.
18        (3) The value of the insulin provided by the
19    manufacturer under paragraphs (1) and (2) of this
20    subsection.
21    As used in this subsection, "value" means the wholesale
22acquisition cost of the insulin provided.
23    (b) By March 15 of each year, beginning March 15, 2023, the
24Board of Pharmacy shall submit the information reported in
25subsection (a) to the General Assembly. The board shall also



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1include in the report any administrative penalties assessed
2under Section 30, including the name of the manufacturer and
3amount of the penalty assessed.
4    Section 30. Penalties.
5    (a) If a manufacturer fails to comply with this Act, the
6Department may assess an administrative penalty of $200,000
7per month of noncompliance, with the penalty increasing to
8$400,000 per month if the manufacturer continues to be in
9noncompliance after 6 months, and increasing to $600,000 per
10month if the manufacturer continues to be in noncompliance
11after one year. The penalty shall remain at $600,000 per month
12for as long as the manufacturer continues to be in
14    (b) A manufacturer is also subject to the administrative
15penalties specified in subsection (a) if the manufacturer
16fails to:
17        (1) provide a hotline for individuals to call or
18    access between 8 a.m. and 10 p.m. on weekdays and between
19    10 a.m. and 6 p.m. on Saturdays; and
20        (2) list on the manufacturer's website the eligibility
21    requirements for the manufacturer's patient assistance
22    programs for Illinois residents.
23    (c) Any penalty assessed under this Act shall be deposited
24into the Insulin Assistance Fund, a special fund that is
25created in the State treasury.



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1    Section 105. The State Finance Act is amended by adding
2Section 5.970 as follows:
3    (30 ILCS 105/5.970 new)
4    Sec. 5.970. The Insulin Assistance Fund.
5    Section 110. The Illinois Insurance Code is amended by
6changing Section 356z.41 as follows:
7    (215 ILCS 5/356z.41)
8    Sec. 356z.41. Cost sharing in prescription insulin drugs;
9limits; confidentiality of rebate information.
10    (a) As used in this Section, "prescription insulin drug"
11means a prescription drug that contains insulin and is used to
12control blood glucose levels to treat diabetes but does not
13include an insulin drug that is administered to a patient
15    (b) This Section applies to a group or individual policy
16of accident and health insurance amended, delivered, issued,
17or renewed on or after the effective date of this amendatory
18Act of the 101st General Assembly.
19    (c) An insurer that provides coverage for prescription
20insulin drugs pursuant to the terms of a health coverage plan
21the insurer offers shall limit the total amount that an
22insured is required to pay for a 30-day supply of covered



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1prescription insulin drugs at an amount not to exceed $35
2$100, regardless of the quantity or type of covered
3prescription insulin drug used to fill the insured's
5    (d) Nothing in this Section prevents an insurer from
6reducing an insured's cost sharing by an amount greater than
7the amount specified in subsection (c).
8    (e) The Director may use any of the Director's enforcement
9powers to obtain an insurer's compliance with this Section.
10    (f) The Department may adopt rules as necessary to
11implement and administer this Section and to align it with
12federal requirements.
13    (g) On January 1 of each year, the limit on the amount that
14an insured is required to pay for a 30-day supply of a covered
15prescription insulin drug shall increase by a percentage equal
16to the percentage change from the preceding year in the
17medical care component of the Consumer Price Index of the
18Bureau of Labor Statistics of the United States Department of
20(Source: P.A. 101-625, eff. 1-1-21.)
21    Section 999. Effective date. This Act takes effect upon
22becoming law.