Sen. Andy Manar

Filed: 10/28/2019





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2    AMENDMENT NO. ______. Amend Senate Bill 667, AS AMENDED,
3with reference to page and line numbers of Senate Amendment No.
42, on page 5, immediately below line 9, by inserting the
6    "Section 11. The Department of Human Services (Mental
7Health and Developmental Disabilities) Law of the Civil
8Administrative Code of Illinois is amended by adding Section
91710-130 as follows:
10    (20 ILCS 1710/1710-130 new)
11    Sec. 1710-130. Insulin Assistance Program.
12    (a) As used in this Section:
13    "Eligible individual" means an individual who is a resident
14of Illinois and:
15        (1) has a family income that is equal to or less than
16    600% of the federal poverty level;



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1        (2) has an out-of-pocket maximum of either $3,000 for
2    prescriptions or has a high deductible health plan; and
3        (3) has not participated in the Program within the past
4    12 months.
5    "High deductible health plan" means a plan offered by a
6health insurance issuer with an out-of-pocket limit of $5,000
7or more.
8    "Valid prescription" means a prescription issued by a
9physician licensed under the Medical Practice Act to practice
10medicine in all of its branches.
11    (b) The Secretary of Human Services shall implement the
12Insulin Assistance Program by July 1, 2021. Under the Program,
13the Secretary shall:
14        (1) reimburse a pharmacy for insulin products and
15    related supplies that are dispensed by the pharmacy to an
16    eligible individual pursuant to a valid prescription;
17        (2) maintain an up-to-date list of eligible
18    individuals and make the list available to participating
19    pharmacies in compliance with all State and federal privacy
20    laws and rules;
21        (3) maintain an up-to-date list of participating
22    pharmacies on the Department's website;
23        (4) accept statements of financial need from persons
24    seeking eligibility for the Program; and
25        (5) seek participation in the Program by pharmacies in
26    all areas of the State.



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1    The Secretary may contract with a private entity or enter
2into an interagency agreement with another State agency to
3implement the Program.
4    (c) The Department shall develop and adopt rules for the
5application process of the Insulin Assistance Program. The
6Secretary shall develop an application form, and it shall be
7made available to participating pharmacies, health care
8providers, and other parties it deems necessary. An applicant
9must include his or her income and insurance status information
10with the application. At a minimum, the application form shall:
11        (1) state that the individual signing the form requires
12    insulin products and related supplies to avoid serious
13    health complications;
14        (2) state that the individual signing the form has
15    attested to the physician or health professional issuing
16    the prescription for insulin products and related supplies
17    that the individual lacks the financial means to pay for
18    these items and meets the requirements of an eligible
19    individual for the Insulin Assistance Program; and
20        (3) provide the signature of both the individual and
21    the physician or health care professional issuing the
22    prescription for insulin products and related supplies.
23    To be considered for the Program, an individual must submit
24the completed application form to the Secretary and submit a
25paper or electronic copy of the form to a participating
26pharmacy when initially filling the prescription. Upon receipt



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1of a completed application, the Secretary shall determine
2eligibility in no more than 15 business days. Once an
3individual has been determined eligible, the individual shall
4be issued an Insulin Assistance Program identification card and
5entered into the system of eligible individuals. An Insulin
6Assistance Program identification card shall be valid for 90
7days beginning on the date the form is approved. An individual
8may renew participation for an additional 90-day period no
9earlier than 12 months after being issued an Insulin Assistance
10Program identification card.
11    (d) Pharmacy participation in the program is voluntary. In
12order to participate, a pharmacy must register with the
13Secretary and agree to reimbursement and other contract terms
14the Secretary determines necessary. A pharmacy may withdraw
15from participation at any time by providing written notice to
16the Secretary. A pharmacy shall dispense insulin products and
17related supplies to eligible individuals who present a valid
18prescription and Insulin Assistance Program identification
19card. If an individual has not yet received an Insulin
20Assistance Program identification card, the individual may be
21verified from the list of eligible individuals maintained by
22the Secretary. Insulin products and related supplies shall be
23dispensed at no cost to eligible individuals. Eligibility for
24the Program is subject to the limits of available funding.
25Before dispensing insulin products and related supplies to an
26eligible individual, a pharmacy must provide the eligible



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1individual with information about any relevant drug
2manufacturer patient discount programs and contact information
4    (e) Notwithstanding subsection (d), an individual with a
5completed and signed application form for the Program has
6presumptive eligibility for the Program. If an individual with
7presumptive eligibility does not have a valid prescription for
8insulin, a pharmacy shall dispense insulin in accordance with
9subsection (c) only if all conditions in Section 15.3 of the
10Pharmacy Practice Act are met.
11    Section 12. The State Finance Act is amended by adding
12Section 5.930 as follows:
13    (30 ILCS 105/5.930 new)
14    Sec. 5.930. Insulin Assistance Account Fund."; and
15on page 14, line 4, after "diabetes", by inserting "but does
16not include an insulin drug that is administered to a patient
17intravenously"; and
18on page 22, immediately below line 12, by inserting the
20    "Section 50. The Pharmacy Practice Act is amended by
21changing Section 10 and by adding Section 10.5 as follows:



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1    (225 ILCS 85/10)  (from Ch. 111, par. 4130)
2    (Section scheduled to be repealed on January 1, 2020)
3    Sec. 10. State Board of Pharmacy.
4    (a) There is created in the Department the State Board of
5Pharmacy. It shall consist of 9 members, 7 of whom shall be
6licensed pharmacists. Each of those 7 members must be a
7licensed pharmacist in good standing in this State, a graduate
8of an accredited college of pharmacy or hold a Bachelor of
9Science degree in Pharmacy and have at least 5 years' practical
10experience in the practice of pharmacy subsequent to the date
11of his licensure as a licensed pharmacist in the State of
12Illinois. There shall be 2 public members, who shall be voting
13members, who shall not be engaged in any way, directly or
14indirectly, as providers of health care in this State or any
15other state.
16    (b) Each member shall be appointed by the Governor.
17    (c) Members shall be appointed to 5 year terms. The
18Governor shall fill any vacancy for the remainder of the
19unexpired term. Partial terms over 3 years in length shall be
20considered full terms. A member may be reappointed for a
21successive term, but no member shall serve more than 2 full
22terms in his or her lifetime.
23    (d) In making the appointment of members on the Board, the
24Governor shall give due consideration to recommendations by the
25members of the profession of pharmacy and by pharmacy



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1organizations therein. The Governor shall notify the pharmacy
2organizations promptly of any vacancy of members on the Board
3and in appointing members shall give consideration to
4individuals engaged in all types and settings of pharmacy
6    (e) The Governor may remove any member of the Board for
7misconduct, incapacity, or neglect of duty, and he or she shall
8be the sole judge of the sufficiency of the cause for removal.
9    (f) Each member of the Board shall be reimbursed for such
10actual and legitimate expenses as he or she may incur in going
11to and from the place of meeting and remaining there during
12sessions of the Board.
13    (g) The Board shall hold quarterly meetings at such times
14and places and upon notice as the Department may determine and
15as its business may require. A majority of the Board members
16currently appointed shall constitute a quorum. A vacancy in the
17membership of the Board shall not impair the right of a quorum
18to exercise all the rights and perform all the duties of the
20    (h) The Board shall exercise the rights, powers and duties
21which have been vested in the Board under this Act, and any
22other duties conferred upon the Board by law.
23    (i) The Board shall publish on its website regularly
24updated information about:
25        (1) pharmaceutical manufacturers' patient assistance
26    programs;



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1        (2) the Illinois' prescription assistance program
2    Illinois Rx Card;
3        (3) the Insulin Assistance Program;
4        (4) websites through which individuals can access
5    information concerning eligibility for and enrollment in
6    Medicare, Medicaid, Get Covered Illinois, and other
7    government-funded programs that help defray the costs of
8    prescriptions;
9        (5) the program established under Section 340b of the
10    federal Public Health Service Act, 42 U.S.C. 256b; and
11        (6) any other resource that the Board deems useful to
12    consumers attempting to purchase prescription drugs at
13    lower costs.
14    The Board shall prepare educational documents and
15materials, including brochures and posters, based on the
16information it provides on its website under this subsection
17(i). The documents and materials shall be in a form that can be
18downloaded from the Board's website and used for patient
19education by pharmacists and by practitioners who are licensed
20to prescribe. The Board is not required to provide printed
21copies of these documents and materials.
22    Annually, the Board shall encourage licensed pharmacists
23and pharmacies to make available to patients information on
24sources of lower cost prescription drugs and shall provide
25these licensees with the address for the website under this
26subsection (i).



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1(Source: P.A. 100-497, eff. 9-8-17.)
2    (225 ILCS 85/10.5 new)
3    Sec. 10.5. Insulin product fee.
4    (a) As used in this Section:
5    "Manufacturer" means a manufacturer engaged in the
6manufacturing of insulin.
7    "Qualified insulin product" means any prescription product
8containing insulin for which the Board determines the wholesale
9acquisition cost of the drug, or other relevant measure of drug
10cost, exceeds the national average for comparable prescription
11products containing insulin.
12    "Wholesaler" means a wholesale drug distributor licensed
13under the Wholesale Drug Distribution Licensing Act and engaged
14in the wholesale drug distribution of insulin.
15    (b) A manufacturer that holds a U.S. Food and Drug
16Administration approved New Drug Application, or approved
17Abbreviated New Drug Application, for any qualified insulin
18product and a wholesaler shall pay to the Board an insulin
19product fee pursuant to this Section.
20    (c) On or before March 1, 2021, and every March 1
21thereafter, a pharmaceutical manufacturer and a wholesaler
22shall provide the Board with data about each of its
23prescription products that contain insulin that are sold,
24delivered, or distributed within or into the State to any
25practitioner, pharmacy, or hospital. The data shall include,



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1for each product, the trade and generic names, strength,
2package size, and National Drug Code. Reporting shall be in a
3manner and format specified by the Board and shall occur by the
415th day of each calendar month, for sales, deliveries, and
5other distributions that occurred during the previous calendar
6month, except that the first report submitted to the Board
7shall include data retroactive to July 1, 2020. Each
8manufacturer and each wholesaler required to report this data
9shall also report a billing address to which the Board may send
10invoices and inquiries related to the insulin product fee. The
11manufacturer and wholesaler shall notify the Board of any
12changes to this data no later than 30 days after the change is
13made. The Board may require a manufacturer or wholesaler to
14confirm the accuracy of the data on a quarterly basis. If a
15manufacturer or wholesaler fails to provide information
16required under this subsection (c) on a timely basis, the Board
17may assess an administrative penalty of $100 per day. This
18penalty shall not be considered a form of disciplinary action.
19    (d) Beginning April 1, 2021 and on a quarterly basis
20thereafter, the Board shall use the data submitted under
21subsection (c) to identify qualified insulin products and
22prepare invoices for each manufacturer and wholesaler that is
23required to pay an insulin product fee for a qualified insulin
24product, as required by this Section. The invoices for each
25quarter shall be prepared and sent to manufacturers and
26wholesalers no later than 30 days after the end of each



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1quarter, except that the first invoice prepared by the Board
2shall be for the first 3 quarters of fiscal year 2020.
3Manufacturers and wholesalers shall remit payment to the Board
4no later than 30 days after the date of the invoice. If a
5manufacturer or wholesaler fails to remit payment by that date,
6the Board shall charge interest at the rate that manufacturers
7and wholesalers are charged interest for making late Medicaid
8rebate payments.
9    (e) A manufacturer or wholesaler may dispute the amount
10invoiced by the Board no later than 30 days after the date of
11the invoice. However, the manufacturer or wholesaler must still
12remit payment for the amount invoiced as required by this
13Section. The dispute shall be filed with the Board in the
14manner and using the forms specified by the Board. A
15manufacturer or wholesaler must submit, with the required
16forms, data satisfactory to the Board that demonstrates that
17the original amount invoiced was incorrect. The Board shall
18make a decision concerning a dispute no later than 60 days
19after receiving the required forms. If the Board determines
20that the manufacturer or wholesaler has satisfactorily
21demonstrated the original fee invoiced by the Board was
22incorrect, the Board shall reimburse the manufacturer or
23wholesaler for any amount that is in excess of the correct
24amount that should have been invoiced. The Board shall make
25this reimbursement when it notifies the manufacturer or
26wholesaler of its decision.



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1    (f) The Board shall calculate the fee that is to be paid by
2each manufacturer and wholesaler by using a base rate for all
3qualified insulin products, as defined by the Board,
4distributed or dispensed in Illinois. The Board shall annually
5assess manufacturers and wholesalers a fee that in the
6aggregate equals the total cost of the Insulin Assistance
7Program for the previous fiscal year, including any State
8appropriation to the Secretary of Human Services for the
9Program and any administrative costs incurred by the Secretary
10of Human Services or the Board in collecting the fees, plus any
11outstanding liabilities of the Program. The Board shall
12determine for each manufacturer or wholesaler a prorated annual
13fee that is based on the manufacturer's or wholesaler's
14percentage of the total number of units reported to the Board
15under subsection (c). For the initial fee, the Secretary shall
16estimate the cost of the Program for the first fiscal year and
17notify the Board of the estimated cost 6 months after the
18effective date of this amendatory Act of the 101st General
19Assembly. The Board shall determine each manufacturer's and
20wholesaler's initial fee based on the estimated cost.
21    (g) There is created within the State treasury a special
22fund called the Insulin Assistance Account Fund in which the
23Board shall deposit all fees collected under this Section.
24Beginning with fiscal year 2021, money in the Insulin
25Assistance Account Fund shall be appropriated to the Secretary
26of Human Services to fund the Insulin Assistance Program under



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1Section 1710-130 of the Department of Human Services (Mental
2Health and Developmental Disabilities) Law of the Civil
3Administrative Code of Illinois.
4    Section 55. The Wholesale Drug Distribution Licensing Act
5is amended by changing Section 30 as follows:
6    (225 ILCS 120/30)  (from Ch. 111, par. 8301-30)
7    (Section scheduled to be repealed on January 1, 2023)
8    Sec. 30. License renewal application procedures.
9    (a) Application for renewal of any license required by this
10Act shall be mailed or emailed to each licensee at least 60
11days before the license expires. If the application for renewal
12with the required fee is not received by the Department before
13the expiration date, the existing license shall lapse and
14become null and void. Failure to renew before the expiration
15date is cause for a late payment penalty, discipline, or both.
16    (b) The Department may not renew a license of a wholesale
17distributor unless the wholesale distributor pays the insulin
18product fee required under Section 10.5 of the Pharmacy
19Practice Act.
20(Source: P.A. 101-420, eff. 8-16-19.)".