Bill Text: IL SB0073 | 2017-2018 | 100th General Assembly | Introduced


Bill Title: Amends the Illinois Food, Drug and Cosmetic Act. Adds provision concerning prescription drug price increases. Requires manufacturers of prescription drugs to notify State purchasers, health insurers, health care service plan providers, and pharmacy benefit managers of specified increases in drug prices at least 30 days before such increase and the cost of specified new prescription drugs 3 days before the commercial availability of a new drug approved by the U.S. Food and Drug Administration or within 3 days after approval by the U.S. Food and Drug Administration if the new drug will be made commercially available within 3 days of such approval. Provides that within 30 days after such notifications, prescription drug manufacturers shall report specified information to the Department of Public Health and requires the Department to publish such information on its website. Provides that failure to report such information to specified entities shall result in a specified administrative penalty. Provides that the Department may adopt rules and issue guidance to implement these provisions and shall be responsible for enforcing these provisions. Contains provisions concerning the confidentiality of pricing information. Repeals provisions concerning prescription drug price increases on January 1, 2022. Effective immediately.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced) 2017-05-19 - Rule 3-9(a) / Re-referred to Assignments [SB0073 Detail]

Download: Illinois-2017-SB0073-Introduced.html


100TH GENERAL ASSEMBLY
State of Illinois
2017 and 2018
SB0073

Introduced 1/12/2017, by Sen. Ira I. Silverstein

SYNOPSIS AS INTRODUCED:
410 ILCS 620/16.2 new

Amends the Illinois Food, Drug and Cosmetic Act. Adds provision concerning prescription drug price increases. Requires manufacturers of prescription drugs to notify State purchasers, health insurers, health care service plan providers, and pharmacy benefit managers of specified increases in drug prices at least 30 days before such increase and the cost of specified new prescription drugs 3 days before the commercial availability of a new drug approved by the U.S. Food and Drug Administration or within 3 days after approval by the U.S. Food and Drug Administration if the new drug will be made commercially available within 3 days of such approval. Provides that within 30 days after such notifications, prescription drug manufacturers shall report specified information to the Department of Public Health and requires the Department to publish such information on its website. Provides that failure to report such information to specified entities shall result in a specified administrative penalty. Provides that the Department may adopt rules and issue guidance to implement these provisions and shall be responsible for enforcing these provisions. Contains provisions concerning the confidentiality of pricing information. Repeals provisions concerning prescription drug price increases on January 1, 2022. Effective immediately.
LRB100 05928 MJP 15955 b
FISCAL NOTE ACT MAY APPLY

A BILL FOR

SB0073LRB100 05928 MJP 15955 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 5. The Illinois Food, Drug and Cosmetic Act is
5amended by adding Section 16.2 as follows:
6 (410 ILCS 620/16.2 new)
7 Sec. 16.2. Prescription drug price increases.
8 (a) This Section shall apply to any manufacturer of a
9prescription drug that is purchased or reimbursed by any of the
10following:
11 (1) A State purchaser, including, but not limited to,
12 State retirement systems, the Department of Corrections,
13 the Department of Healthcare and Family Services, the
14 Department of Public Health, or any entity acting on behalf
15 of a State purchaser.
16 (2) A health insurer.
17 (3) A health care service plan provider.
18 (4) A pharmacy benefit manager.
19 (b) On and after January 1, 2018, a manufacturer of a
20prescription drug with a wholesale acquisition cost per month
21supply or per a course of treatment that lasts less than a
22month that comes within the schedule set forth in subsection
23(c) of this Section shall provide written notice to State

SB0073- 2 -LRB100 05928 MJP 15955 b
1purchasers, health insurers, health care service plan
2providers, and pharmacy benefit managers if the manufacturer is
3increasing the wholesale price of the prescription drug during
4any 12-month period by 25% or more, or by more than $10,000.
5The notice shall be provided in writing at least 30 days prior
6to the planned effective date of the increase. Within 30 days
7after notification of a price increase as provided in this
8subsection (b), a manufacturer shall report the following
9information to the Department of Public Health:
10 (1) the previous year's marketing budget for the drug,
11 the manufacturer may limit the information to that which is
12 publicly available;
13 (2) the date and price of acquisition if the drug was
14 not developed by the manufacturer; and
15 (3) a schedule of price increases for the drug for the
16 previous 5 years if it was manufactured by the company, or
17 if the drug was acquired by the manufacturer within the
18 previous 5 years, the price of the drug at the time of the
19 acquisition and in the calendar year prior to acquisition.
20 The Department of Public Health shall publish data
21collected pursuant to this subsection (b) publicly on its
22website no less than quarterly.
23 (c) A manufacturer shall provide the notice required
24pursuant to subsection (b) of this Section if the prescription
25drug wholesale acquisition cost per month supply or per a
26course of treatment that lasts less than a month is within the

SB0073- 3 -LRB100 05928 MJP 15955 b
1following amounts:
2 (1) For calendar year 2018, $100 or more.
3 (2) For calendar year 2019, $105 or more.
4 (3) For calendar year 2020, $110 or more.
5 (4) On and after January 1, 2021, $116 or more.
6 (d) On and after January 1, 2018, a manufacturer of a
7prescription drug shall provide written notice to State
8purchasers, health insurers, health care service plan
9providers, and pharmacy benefit managers if the manufacturer is
10introducing a new prescription drug to market at a wholesale
11cost of $10,000 or more annually or per course of treatment.
12The notice shall be provided in writing 3 days before the
13commercial availability of a drug approved by the federal Food
14and Drug Administration (FDA). In a case in which the
15commercial availability is expected within 3 days of FDA
16approval, a manufacturer may provide a notice pending FDA
17approval in order to ensure approved drugs are commercially
18available without delay, unless any other law prohibits that
19notification, in which case the notice shall be provided as
20soon as practicable, but no later than 3 days after FDA
21approval. Within 30 days after notification of approval for a
22new drug as provided in this subsection (d), a manufacturer
23shall report the following information to the Department of
24Public Health:
25 (1) the expected marketing budget for the drug; and
26 (2) the date and price of acquisition if the drug was

SB0073- 4 -LRB100 05928 MJP 15955 b
1 not developed by the manufacturer.
2 The Department of Public Health shall publish data
3collected pursuant to this subsection (d) publicly on its
4website no less than quarterly.
5 (e) Except for prescription drugs subject to subsection (d)
6of this Section, notice shall not be required for a
7prescription drug that is not already purchased or reimbursed
8by a purchaser described in subsection (a) of this Section.
9 (f) The Department of Public Health may adopt rules or
10issue guidance to implement this Section. The Department of
11Public Health may consult with the Department of Insurance, the
12Department of Healthcare and Family Services, the State Board
13of Pharmacy, any State purchaser of prescription drugs, or
14entity acting on behalf of a State purchaser, in adopting
15necessary rules, in issuing guidance, in posting information on
16its website under this Section, and in taking any other action
17for the purpose of implementing this Section.
18 (g) The Department of Public Health shall be responsible
19for enforcing the provisions of this Section.
20 (h) Any manufacturer of a prescription drug subject to this
21Section shall comply with the provisions of this Section. Any
22manufacturer of a prescription drug subject to this Section
23that does not report the information required pursuant to this
24Section to State purchasers, health care service plans, health
25insurers, or pharmacy benefit managers is liable for an
26administrative penalty of $1,000 a day for every day after the

SB0073- 5 -LRB100 05928 MJP 15955 b
130-day notification period, the administrative penalty shall
2be assessed by the Department of Public Health. The Department
3of Public Health may order the penalty to be paid after
4appropriate notice and an opportunity for a hearing.
5 (i) This Section shall not restrict the legal ability of a
6pharmaceutical manufacturer to change prices as permitted
7under federal law.
8 (j) For purposes of this subsection (j), "pricing
9information" means advanced notification of a price increase
10pursuant to subsection (b) of this Section or advanced
11notification of the price of a new drug pursuant to subsection
12(d) of this Section.
13 (1) Until the effective date of the increase, pricing
14 information shall be deemed confidential information that
15 shall not be made public by an entity described in
16 paragraph (1) of subsection (a) of this Section and is
17 exempt from disclosure under the Freedom of Information
18 Act.
19 (2) Until the effective date of the increase, pricing
20 information shall be deemed confidential information that
21 shall not be made public by an entity described in
22 paragraphs (2), (3), or (4) of subsection (a) of this
23 Section.
24 (3) Notwithstanding paragraph (2) of this subsection
25 (j), an entity described in paragraph (2) or (3) of
26 subsection (a) of this Section may, and an entity described

SB0073- 6 -LRB100 05928 MJP 15955 b
1 in paragraph (4) of subsection (a) of this Section shall,
2 disclose pricing information to its contracting public and
3 private purchasers that agree to maintain the
4 confidentiality of the pricing information until the
5 effective date of the increase. Pricing information
6 received by a contracting public or private purchaser
7 pursuant to this Section shall be deemed confidential
8 information that shall not be made public by a contracting
9 public or private purchaser and is exempt from disclosure
10 under the Freedom of Information Act.
11 (4) Disclosure of pricing information by a
12 pharmaceutical manufacturer pursuant to this Section shall
13 not constitute a waiver of any protection of the
14 information provided by any other law.
15 (k) This Section is repealed on January 1, 2022.
16 Section 99. Effective date. This Act takes effect upon
17becoming law.
feedback