Full Text of SB0667 101st General Assembly
SB0667sam004 101ST GENERAL ASSEMBLY | Sen. Andy Manar Filed: 10/28/2019
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| 1 | | AMENDMENT TO SENATE BILL 667
| 2 | | AMENDMENT NO. ______. Amend Senate Bill 667, AS AMENDED, | 3 | | with reference to page and line numbers of Senate Amendment No. | 4 | | 2, on page 5, immediately below line 9, by inserting the | 5 | | following:
| 6 | | "Section 11. The Department of Human Services (Mental | 7 | | Health and Developmental
Disabilities) Law of the Civil | 8 | | Administrative Code of Illinois is amended by adding Section | 9 | | 1710-130 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 | 14 | | of 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 | 6 | | health insurance issuer with an out-of-pocket limit of $5,000 | 7 | | or more. | 8 | | "Valid prescription" means a prescription issued by a | 9 | | physician licensed under the Medical Practice Act to practice | 10 | | medicine in all of its branches. | 11 | | (b) The Secretary of Human Services shall implement the | 12 | | Insulin Assistance Program by July 1, 2021. Under the Program, | 13 | | the 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 | 2 | | into an interagency agreement with another State agency to | 3 | | implement the Program. | 4 | | (c) The Department shall develop and adopt rules for the | 5 | | application process of the Insulin Assistance Program. The | 6 | | Secretary shall develop an application form, and it shall be | 7 | | made available to participating pharmacies, health care | 8 | | providers, and other parties it deems necessary. An applicant | 9 | | must include his or her income and insurance status information | 10 | | with 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 | 24 | | the completed application form to the Secretary and submit a | 25 | | paper or electronic copy of the form to a participating | 26 | | pharmacy when initially filling the prescription. Upon receipt |
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| 1 | | of a completed application, the Secretary shall determine | 2 | | eligibility in no more than 15 business days. Once an | 3 | | individual has been determined eligible, the individual shall | 4 | | be issued an Insulin Assistance Program identification card and | 5 | | entered into the system of eligible individuals. An Insulin | 6 | | Assistance Program identification card shall be valid for 90 | 7 | | days beginning on the date the form is approved. An individual | 8 | | may renew participation for an additional 90-day period no | 9 | | earlier than 12 months after being issued an Insulin Assistance | 10 | | Program identification card. | 11 | | (d) Pharmacy participation in the program is voluntary. In | 12 | | order to participate, a pharmacy must register with the | 13 | | Secretary and agree to reimbursement and other contract terms | 14 | | the Secretary determines necessary. A pharmacy may withdraw | 15 | | from participation at any time by providing written notice to | 16 | | the Secretary. A pharmacy shall dispense insulin products and | 17 | | related supplies to eligible individuals who present a valid | 18 | | prescription and Insulin Assistance Program identification | 19 | | card. If an individual has not yet received an Insulin | 20 | | Assistance Program identification card, the individual may be | 21 | | verified from the list of eligible individuals maintained by | 22 | | the Secretary. Insulin products and related supplies shall be | 23 | | dispensed at no cost to eligible individuals. Eligibility for | 24 | | the Program is subject to the limits of available funding. | 25 | | Before dispensing insulin products and related supplies to an | 26 | | eligible individual, a pharmacy must provide the eligible |
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| 1 | | individual with information about any relevant drug | 2 | | manufacturer patient discount programs and contact information | 3 | | for GetCoveredIllinois.gov. | 4 | | (e) Notwithstanding subsection (d), an individual with a | 5 | | completed and signed application form for the Program has | 6 | | presumptive eligibility for the Program. If an individual with | 7 | | presumptive eligibility does not have a valid prescription for | 8 | | insulin, a pharmacy shall dispense insulin in accordance with | 9 | | subsection (c) only if all conditions in Section 15.3 of the | 10 | | Pharmacy Practice Act are met. | 11 | | Section 12. The State Finance Act is amended by adding | 12 | | Section 5.930 as follows: | 13 | | (30 ILCS 105/5.930 new) | 14 | | Sec. 5.930. Insulin Assistance Account Fund. "; and | 15 | | on page 14, line 4, after " diabetes ", by inserting " but does | 16 | | not include an insulin drug that is administered to a patient | 17 | | intravenously "; and | 18 | | on page 22, immediately below line 12, by inserting the | 19 | | following: | 20 | | "Section 50. The Pharmacy Practice Act is amended by | 21 | | changing 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 | 5 | | Pharmacy.
It shall consist of 9 members, 7 of whom shall be | 6 | | licensed pharmacists.
Each of those 7 members must be a | 7 | | licensed pharmacist in good standing
in this State, a graduate | 8 | | of an accredited college of pharmacy or hold
a Bachelor of | 9 | | Science degree in Pharmacy and have at least 5 years'
practical | 10 | | experience in the practice of pharmacy subsequent to the
date | 11 | | of his licensure as a licensed pharmacist in the State of | 12 | | Illinois.
There shall be 2 public members, who shall be voting | 13 | | members, who
shall not be engaged in any way, directly or | 14 | | indirectly, as providers of health care in this State or any | 15 | | other state.
| 16 | | (b) Each member shall be appointed by the Governor.
| 17 | | (c) Members
shall be appointed to 5 year terms. The | 18 | | Governor shall fill any vacancy for the remainder of the | 19 | | unexpired term. Partial terms over 3 years in length shall be | 20 | | considered full terms. A member may be reappointed for a | 21 | | successive term, but no member shall serve more than 2 full | 22 | | terms in his or her lifetime.
| 23 | | (d) In making the appointment of members on the Board, the | 24 | | Governor shall
give due consideration to recommendations by the | 25 | | members of the profession
of pharmacy and by pharmacy
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| 1 | | organizations therein. The Governor
shall notify the pharmacy
| 2 | | organizations promptly of any vacancy
of members on the Board | 3 | | and in appointing members shall give consideration
to | 4 | | individuals engaged in all types and settings of pharmacy | 5 | | practice.
| 6 | | (e) The Governor may remove any member of the Board for | 7 | | misconduct, incapacity,
or neglect of duty, and he or she shall | 8 | | be the sole judge of the sufficiency of the
cause for removal.
| 9 | | (f) Each member of the Board shall be reimbursed for such | 10 | | actual
and legitimate expenses as he or she may incur in going | 11 | | to and from the place
of meeting and remaining there during | 12 | | sessions of the Board.
| 13 | | (g) The Board shall hold quarterly meetings at such times | 14 | | and places and upon
notice as the Department
may determine and | 15 | | as its business may require.
A majority of the Board members | 16 | | currently appointed shall constitute a quorum. A vacancy in the | 17 | | membership of the Board shall not impair the right of a quorum | 18 | | to exercise all the rights and perform all the duties of the | 19 | | Board.
| 20 | | (h) The Board shall exercise the rights, powers and duties | 21 | | which have been
vested in the Board under this Act, and any | 22 | | other duties conferred
upon the Board by law. | 23 | | (i) The Board shall publish on its website regularly | 24 | | updated 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 | 15 | | materials, including brochures and posters, based on the | 16 | | information it provides on its website under this subsection | 17 | | (i). The documents and materials shall be in a form that can be | 18 | | downloaded from the Board's website and used for patient | 19 | | education by pharmacists and by practitioners who are licensed | 20 | | to prescribe. The Board is not required to provide printed | 21 | | copies of these documents and materials. | 22 | | Annually, the Board shall encourage licensed pharmacists | 23 | | and pharmacies to make available to patients information on | 24 | | sources of lower cost prescription drugs and shall provide | 25 | | these licensees with the address for the website under this | 26 | | subsection (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 | 6 | | manufacturing of insulin. | 7 | | "Qualified insulin product" means any prescription product | 8 | | containing insulin for which the Board determines the wholesale | 9 | | acquisition cost of the drug, or other relevant measure of drug | 10 | | cost, exceeds the national average for comparable prescription | 11 | | products containing insulin. | 12 | | "Wholesaler" means a wholesale drug distributor licensed | 13 | | under the Wholesale Drug Distribution Licensing Act and engaged | 14 | | in the wholesale drug distribution of insulin. | 15 | | (b) A manufacturer that holds a U.S. Food and Drug | 16 | | Administration approved New Drug Application, or approved | 17 | | Abbreviated New Drug Application, for any qualified insulin | 18 | | product and a wholesaler shall pay to the Board an insulin | 19 | | product fee pursuant to this Section. | 20 | | (c) On or before March 1, 2021, and every March 1 | 21 | | thereafter, a pharmaceutical manufacturer and a wholesaler | 22 | | shall provide the Board with data about each of its | 23 | | prescription products that contain insulin that are sold, | 24 | | delivered, or distributed within or into the State to any | 25 | | practitioner, pharmacy, or hospital. The data shall include, |
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| 1 | | for each product, the trade and generic names, strength, | 2 | | package size, and National Drug Code. Reporting shall be in a | 3 | | manner and format specified by the Board and shall occur by the | 4 | | 15th day of each calendar month, for sales, deliveries, and | 5 | | other distributions that occurred during the previous calendar | 6 | | month, except that the first report submitted to the Board | 7 | | shall include data retroactive to July 1, 2020. Each | 8 | | manufacturer and each wholesaler required to report this data | 9 | | shall also report a billing address to which the Board may send | 10 | | invoices and inquiries related to the insulin product fee. The | 11 | | manufacturer and wholesaler shall notify the Board of any | 12 | | changes to this data no later than 30 days after the change is | 13 | | made. The Board may require a manufacturer or wholesaler to | 14 | | confirm the accuracy of the data on a quarterly basis. If a | 15 | | manufacturer or wholesaler fails to provide information | 16 | | required under this subsection (c) on a timely basis, the Board | 17 | | may assess an administrative penalty of $100 per day. This | 18 | | penalty shall not be considered a form of disciplinary action. | 19 | | (d) Beginning April 1, 2021 and on a quarterly basis | 20 | | thereafter, the Board shall use the data submitted under | 21 | | subsection (c) to identify qualified insulin products and | 22 | | prepare invoices for each manufacturer and wholesaler that is | 23 | | required to pay an insulin product fee for a qualified insulin | 24 | | product, as required by this Section. The invoices for each | 25 | | quarter shall be prepared and sent to manufacturers and | 26 | | wholesalers no later than 30 days after the end of each |
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| 1 | | quarter, except that the first invoice prepared by the Board | 2 | | shall be for the first 3 quarters of fiscal year 2020. | 3 | | Manufacturers and wholesalers shall remit payment to the Board | 4 | | no later than 30 days after the date of the invoice. If a | 5 | | manufacturer or wholesaler fails to remit payment by that date, | 6 | | the Board shall charge interest at the rate that manufacturers | 7 | | and wholesalers are charged interest for making late Medicaid | 8 | | rebate payments. | 9 | | (e) A manufacturer or wholesaler may dispute the amount | 10 | | invoiced by the Board no later than 30 days after the date of | 11 | | the invoice. However, the manufacturer or wholesaler must still | 12 | | remit payment for the amount invoiced as required by this | 13 | | Section. The dispute shall be filed with the Board in the | 14 | | manner and using the forms specified by the Board. A | 15 | | manufacturer or wholesaler must submit, with the required | 16 | | forms, data satisfactory to the Board that demonstrates that | 17 | | the original amount invoiced was incorrect. The Board shall | 18 | | make a decision concerning a dispute no later than 60 days | 19 | | after receiving the required forms. If the Board determines | 20 | | that the manufacturer or wholesaler has satisfactorily | 21 | | demonstrated the original fee invoiced by the Board was | 22 | | incorrect, the Board shall reimburse the manufacturer or | 23 | | wholesaler for any amount that is in excess of the correct | 24 | | amount that should have been invoiced. The Board shall make | 25 | | this reimbursement when it notifies the manufacturer or | 26 | | wholesaler of its decision. |
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| 1 | | (f) The Board shall calculate the fee that is to be paid by | 2 | | each manufacturer and wholesaler by using a base rate for all | 3 | | qualified insulin products, as defined by the Board, | 4 | | distributed or dispensed in Illinois. The Board shall annually | 5 | | assess manufacturers and wholesalers a fee that in the | 6 | | aggregate equals the total cost of the Insulin Assistance | 7 | | Program for the previous fiscal year, including any State | 8 | | appropriation to the Secretary of Human Services for the | 9 | | Program and any administrative costs incurred by the Secretary | 10 | | of Human Services or the Board in collecting the fees, plus any | 11 | | outstanding liabilities of the Program. The Board shall | 12 | | determine for each manufacturer or wholesaler a prorated annual | 13 | | fee that is based on the manufacturer's or wholesaler's | 14 | | percentage of the total number of units reported to the Board | 15 | | under subsection (c). For the initial fee, the Secretary shall | 16 | | estimate the cost of the Program for the first fiscal year and | 17 | | notify the Board of the estimated cost 6 months after the | 18 | | effective date of this amendatory Act of the 101st General | 19 | | Assembly. The Board shall determine each manufacturer's and | 20 | | wholesaler's initial fee based on the estimated cost. | 21 | | (g) There is created within the State treasury a special | 22 | | fund called the Insulin Assistance Account Fund in which the | 23 | | Board shall deposit all fees collected under this Section. | 24 | | Beginning with fiscal year 2021, money in the Insulin | 25 | | Assistance Account Fund shall be appropriated to the Secretary | 26 | | of Human Services to fund the Insulin Assistance Program under |
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| 1 | | Section 1710-130 of the Department of Human Services (Mental | 2 | | Health and Developmental
Disabilities) Law of the Civil | 3 | | Administrative Code of Illinois. | 4 | | Section 55. The Wholesale Drug Distribution Licensing Act | 5 | | is 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 | 10 | | Act shall be mailed or emailed to each
licensee at least 60 | 11 | | days before the license expires. If the application
for renewal | 12 | | with the required fee is not received by the Department before
| 13 | | the expiration date, the existing license shall lapse and | 14 | | become null and
void. Failure to renew before the expiration | 15 | | date is cause for a late
payment penalty, discipline, or both. | 16 | | (b) The Department may not renew a license of a wholesale | 17 | | distributor unless the wholesale distributor pays the insulin | 18 | | product fee required under Section 10.5 of the Pharmacy | 19 | | Practice Act.
| 20 | | (Source: P.A. 101-420, eff. 8-16-19.)".
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