Rep. Mary E. Flowers

Filed: 3/21/2019

 

 


 

 


 
10100HB0053ham001LRB101 04687 CPF 58108 a

1
AMENDMENT TO HOUSE BILL 53

2    AMENDMENT NO. ______. Amend House Bill 53 by replacing
3everything after the enacting clause with the following:
 
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.

 

 

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1        (3) A health care service plan provider.
2        (4) A pharmacy benefit manager.
3    (b) A manufacturer of a prescription drug with a wholesale
4acquisition cost of more than $40 for a course of therapy shall
5notify each party described in subsection (a) if there is an
6increase in the wholesale acquisition cost of the prescription
7drug of more than 10%, including the proposed increase and
8cumulative increase that has occurred within the previous 2
9calendar years prior to the date of the proposed increase.
10    For purposes of this subsection, "course of therapy" means
11either of the following:
12        (1) The recommended daily dosage units of a
13    prescription drug pursuant to its prescribing label as
14    approved by the federal Food and Drug Administration for a
15    normal course of treatment that is 30 days or more.
16        (2) The recommended daily dosage units of a
17    prescription drug pursuant to its prescribing label as
18    approved by the federal Food and Drug Administration for a
19    normal course of treatment that is less than 30 days.
20    (c) The notice required under subsection (b) shall be
21provided in writing at least 60 days prior to the planned date
22of the increase in the wholesale acquisition cost.
23    (d) No later than 30 days after providing notification of a
24price increase under subsection (b), a manufacturer shall
25report the following information to each party described in
26subsection (a):

 

 

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1        (1) The latest applicable wholesale acquisition cost.
2        (2) The date of the latest previous increase in
3    wholesale acquisition cost.
4        (3) The per-unit dollar amount of the scheduled
5    increase in wholesale acquisition cost.
6        (4) A schedule of wholesale acquisition cost increases
7    for the previous 5 years, where available, or for the years
8    since the drug has been approved by the federal Food and
9    Drug Administration if that length of time is less than 5
10    years.
11        (5) The date and price of acquisition, if the drug was
12    not developed by the manufacturer.
13        (6) A description of each financial and non-financial
14    factor that contributes to the wholesale acquisition cost,
15    including the following:
16            (A) A percentage of the price attributable to each
17        factor.
18            (B) An explanation of the role of each factor in
19        the price of the drug.
20    (e) A manufacturer of a prescription drug shall provide
21written notice to each party described in subsection (a) if the
22manufacturer is introducing a new prescription drug to market
23at a wholesale acquisition cost that exceeds the threshold set
24for a specialty drug under the Medicare Part D program. This
25notice shall be provided no later than 30 days prior to the
26release of the drug on the commercial market.

 

 

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1    (f) No later than 30 days after providing the notification
2of a new prescription drug under subsection (e), a manufacturer
3shall report the following information to each party described
4in subsection (a):
5        (1) The latest applicable wholesale acquisition cost.
6        (2) The date of the latest previous increase in
7    wholesale acquisition cost.
8        (3) The per-unit dollar amount of the scheduled
9    increase in wholesale acquisition cost.
10        (4) A schedule of wholesale acquisition costs
11    increases for the previous 5 years, where available, or for
12    the years since the drug has been approved by the federal
13    Food and Drug Administration if that length of time is less
14    than 5 years.
15        (5) The date and price of acquisition, if the drug was
16    not developed by the manufacturer.
17        (6) A description of each financial and non-financial
18    factor that contributes to the wholesale acquisition cost,
19    including the following:
20            (A) A percentage of the price attributable to each
21        factor.
22            (B) An explanation of the role of each factor in
23        the price of the drug.
24    (g) Failure to provide the information required under
25subsections (b), (d), (e), or (f) to each party described in
26subsection (a) shall result in a civil penalty of $10,000 per

 

 

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1day for every day after the notification period that the
2manufacturer fails to provide the information.
3    (h) The Department of Public Health shall conduct an annual
4public hearing on the aggregate trends in prescription drug
5pricing. The hearing shall provide for public discussion of
6overall price increases, emerging trends, decreases in drug
7spending, and the impact of prescription drug spending on
8health care affordability and premiums.
9    (i) The Department of Public Health shall publish on its
10website a report detailing findings from the public hearing
11held under subsection (h) and a summary of information provided
12under subsections (b), (d), (e), and (f).
13    (j) The Department of Public Health may not post on its
14website any information described in subsections (d) or (f) of
15this Section that is identified as a trade secret under the
16Illinois Trade Secrets Act.
17    (k) The Department of Public Health shall keep confidential
18all information provided to the Department that would qualify
19for an exemption under Section 7 of the Freedom of Information
20Act.
21    (l) This Section shall not restrict the legal ability of a
22pharmaceutical manufacturer to change prices as permitted
23under federal law.".