Bill Amendment: IL SB0667 | 2019-2020 | 101st General Assembly

NOTE: For additional amemendments please see the Bill Drafting List

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Bill Title: PRICING-PRESCRIPTION INSULIN

Status: 2020-01-24 - Public Act . . . . . . . . . 101-0625 [SB0667 Detail]

Download: Illinois-2019-SB0667-Senate_Amendment_004.html

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Sen. Andy Manar

Filed: 10/28/2019

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

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

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

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

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

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

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

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

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

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

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

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

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