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131st MAINE LEGISLATURE
SECOND REGULAR SESSION-2024
Legislative Document No. 2282S.P. 996 In Senate, March 27, 2024
An Act to Provide Greater Transparency About the Cost of Insulin
and to Promote the Availability of Low-cost Insulin in the State
Reported by the Majority from the Joint Standing Committee on Health Coverage,
Insurance and Financial Services pursuant to Joint Order 2023, S.P. 968.
DAREK M. GRANT
Secretary of the Senate Page 1 - 131LR3161(01)
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2 is enacted to read:
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4 intermediate-acting, long-acting and premixed insulin for which at least 2 licenses have
5 been issued by the federal Food and Drug Administration and are actively marketed
6 pursuant to such licensure in a category.
7 is enacted to read:
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9 subsection 1, paragraph A and includes insulin or an insulin pen that is licensed under the
10 federal Public Health Service Act, 42 United States Code, Section 262(a) or 262(k).
11 is enacted to read:
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13 than February 15th of each year, a manufacturer of insulin shall notify the organization of
14 the wholesale acquisition cost per pricing unit for the insulin produced by the manufacturer
15 in each category of insulin.
16 as enacted by PL 2021, c. 303, §5, is amended
17 to read:
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19 total of insulin sold, delivered or distributed in this State does not exceed 500,000 units of
20 insulin in the year in which a registration fee under subsection 1 is due is not required to
21 pay the registration fee. To qualify for the exception under this subsection, a manufacturer
22 must demonstrate to the board, by January 31st of the year following the year in which the
23 registration fee is due, in a manner determined by the board, that the aggregate total of
24 insulin produced by the manufacturer that was sold, delivered or distributed within this
25 State in the year in which the manufacturer seeks to claim the exception did not exceed
26 500,000 units. The board may adopt rules to implement this section. Rules adopted
27 pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375,
28 subchapter 2‑A.
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30 This bill is being reported out by the Joint Standing Committee on Health Coverage,
31 Insurance and Financial Services pursuant to Joint Order 2023, S.P. 968. The bill requires
32 a manufacturer of insulin to notify the Maine Health Data Organization no later than
33 February 15th of each year of the wholesale acquisition cost for the insulin produced by
34 the manufacturer in each category of insulin. The bill also provides that a manufacturer of
35 insulin that is a nonprofit organization is not required to pay an annual insulin product
36 registration fee.
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3738 Approved: 03/22/24
LD 2282 LR 3161(01)
Fiscal Detail and Notes
131st MAINE LEGISLATURE
This bill exempts a manufacturer of insulin that is a nonprofit organization from paying the $75,000 registration fee. It
is unclear whether any such organizations currently manufacture insulin, but manufacturers of 500,000 units or less
are already exempt from the fee. Any decrease in dedicated revenue to the Maine Board of Pharmacy within the
Department of Professional and Financial Regulation cannot be determined at this time.
Any additional costs to the Maine Health Data Organization from the provisions of this bill are expected to be minor
and can be absorbed within existing budgeted resources.
An Act to Provide Greater Transparency About the Cost of Insulin and to Promote the Availability of
Low-cost Insulin in the State
Fiscal Note Original Bill
Committee: Health Coverage, Insurance and Financial Services
Fiscal Note Required: Yes
Fiscal Note
Current biennium revenue decrease - Other Special Revenue Funds
Minor cost increase - General Fund
LR3161(01) - Fiscal Note - Page 1 of 1