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Full Text of HB4954
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HB4954 - 104th General Assembly
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104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026
HB4954
Introduced , by Rep. Martha Deuter
SYNOPSIS AS INTRODUCED:
New Act
Creates the 340B Drug Pricing Program Reporting Act. On or before
April 1, 2027 and each April 1 thereafter, requires a 340B covered entity
to report the specified information and transactions to the Department of
Public Health concerning the 340B covered entity's participation in or
participation on behalf of the 340B covered entity in the federal 340B
Program for the previous calendar year. On or before November 15, 2027 and
each November 15 thereafter, requires the Department to prepare a report
that aggregates the data submitted; submit the report to the General
Assembly in an electronic format; and post the report on the Department's
website. Provides that pharmaceutical manufacturers may request a 340B
covered entity to provide specified information concerning the
dispensation of 340B drugs. Sets forth provisions concerning penalties,
exemptions for pharmaceutical manufacturers, and rulemaking. Provides that
the Act is repealed on January 1, 2031. Effective immediately.
LRB104 17048 BAB 30463 b
A BILL FOR
HB4954
LRB104 17048 BAB 30463 b
1
AN ACT concerning regulation.
2
Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:
4
Section 1.
Short title.
This Act may be cited as the
340B
5
Drug Pricing Program Reporting Act.
6
Section 5.
Definitions.
In this Act:
7
"340B covered entity" or "covered entity" means a covered
8
entity, as defined in 42 U.S.C. 256b(a)(4), with a service
9
address in Illinois as of January 1 of the reporting year.
10
"340B covered entity" includes all entity types and grantees
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and all facilities that are identified as child sites or
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grantee associated sites under the federal 340B Drug Pricing
13
Program.
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"340B Drug Pricing Program" or "340B Program" means the
15
drug discount program established under 42 U.S.C. 256b.
16
"340B entity type" means the designation of the 340B
17
covered entity according to the entity types specified in 42
18
U.S.C. 256b(a)(4).
19
"340B identification number" means the unique
20
identification number provided by the Health Resources and
21
Services Administration to identify a 340B-eligible entity in
22
the 340B Office of Pharmacy Affairs Information System.
23
"Contract pharmacy" means a pharmacy with which a 340B
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covered entity has an arrangement to dispense drugs purchased
2
under the 340B Drug Pricing Program.
3
"Department" means the Department of Public Health.
4
"Pharmaceutical manufacturer" means any entity that is
5
engaged in:
6
(1) the production, preparation, propagation,
7
compounding, conversion, or processing of prescription
8
drug products, either directly or indirectly by extraction
9
from substances of natural origin, independently by means
10
of chemical synthesis, or by a combination of extraction
11
and chemical synthesis; or
12
(2) the packaging, repackaging, labeling, relabeling,
13
or distribution of prescription drug products.
14
"Pharmaceutical manufacturer" does not include a wholesale
15
distributor of drugs or a retail pharmacy licensed under State
16
law.
17
Section 10.
Registration and reporting requirements.
18
(a) On or before April 1, 2027 and each April 1 thereafter,
19
a 340B covered entity shall report the following information
20
and transactions to the Department concerning the 340B covered
21
entity's participation in or participation on behalf of the
22
340B covered entity in the federal 340B Program for the
23
previous calendar year:
24
(1) With respect to the 340B covered entity, the:
25
(A) name;
HB4954
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(B) service address;
2
(C) 340B Program identification number; and
3
(D) designation of entity type, as specified in 42
4
U.S.C. 256b(a)(4).
5
(2) The aggregate acquisition cost for all
6
prescription drugs obtained under the 340B Program and
7
dispensed or administered to patients.
8
(3) The aggregate payment amount received for all
9
drugs obtained under the 340B Program and dispensed or
10
administered to patients.
11
(4) The aggregate payment made to contract pharmacies
12
to dispense drugs obtained under the 340B Program.
13
(5) The number of claims for prescription drugs
14
described in paragraph (3).
15
(6) How the 340B covered entity uses any savings from
16
participating in the 340B Program, including the amount of
17
savings used for the provision of charity care, community
18
benefits, or a similar program of providing unreimbursed
19
or subsidized health care.
20
(7) The aggregate payments made to any other entity
21
that is not a 340B covered entity and is not a contract
22
pharmacy as described in paragraph (4) for managing any
23
aspect of the 340B covered entity's 340B Program.
24
(8) The aggregate payment made for any other
25
administering expense for the 340B Program.
26
(9) The aggregate number of prescription drugs
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dispensed or administered to patients for which a payment
2
was reported under paragraph (3).
3
(10) The percentage of the 340B covered entity's
4
claims that were for prescription drugs obtained under the
5
340B Program.
6
(11) The number and percentage of low-income patients
7
of the 340B covered entity that were served by a sliding
8
fee scale for a prescription drug dispensed or
9
administered under the 340B Program.
10
(12) The 340B covered entity's total operating costs.
11
(13) The 340B covered entity's total costs for charity
12
care.
13
(14) A copy of the 340B covered entity's financial
14
assistance policy for the reporting year.
15
(b) The information required to be reported under
16
paragraphs (3) through (5) of subsection (a) must, to the
17
extent feasible, be reported by payer type, including the
18
following:
19
(1) Commercial.
20
(2) Medicaid.
21
(3) Medicare.
22
(4) Uninsured.
23
(c) The data submitted in the reports required under
24
subsection (a) is confidential and is not available for public
25
inspection.
26
(d) On or before November 15, 2027 and each November 15
HB4954
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thereafter, the Department shall:
2
(1) prepare a report that aggregates the data
3
submitted under subsection (a);
4
(2) submit the report to the General Assembly in an
5
electronic format; and
6
(3) post the report on the Department's website.
7
Section 15.
Penalties.
A 340B covered entity that fails to
8
provide the information required under Section 10 by the date
9
required shall pay to the Department a fine of $1,000 per day
10
for which the information is past due.
11
Section 20.
Exemptions for pharmaceutical manufacturers.
12
(a) Nothing in this Act shall deny, restrict, or prohibit
13
a pharmaceutical manufacturer from obtaining the same data
14
compiled and submitted by a 340B covered entity and provided
15
to:
16
(1) payors for reimbursement; or
17
(2) any other entity managing any aspect of the 340B
18
covered entity's 340B Program, such as third-party
19
administrators.
20
(b) Pharmaceutical manufacturers may use the compiled data
21
for purposes of identifying and investigating duplicate
22
discounts or diversion and verifying that a request made by a
23
340B covered entity, its 340B contract pharmacy, or a location
24
otherwise authorized by a 340B covered entity to receive 340B
HB4954
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drugs, pertains to a drug dispensed to a patient of that 340B
2
covered entity. A pharmaceutical manufacturer may request that
3
a 340B covered entity provide data that includes, without
4
limitation, the following:
5
(1) the date of service that the 340B drug was
6
dispensed;
7
(2) the date that the 340B drug was prescribed;
8
(3) the Rx number, also known as a prescription
9
number, which is a unique identifier that a pharmacy
10
assigns to each specific prescription filled or provided
11
for a patient;
12
(4) the fill number for each 340B drug provided to a
13
patient, which shall indicate whether that specific
14
instance is the original or a subsequent fill of that
15
particular container;
16
(5) the National Drug Code (NDC) number for the 340B
17
drug dispensed, as used by the United States Food and Drug
18
and published in the NDC Directory;
19
(6) the quantity of the 340B drugs dispensed;
20
(7) the appropriate prescriber ID or National Provider
21
Identifier (NPI), which shall be the unique number
22
identifying the health care provider who wrote the 340B
23
drug prescription;
24
(8) the service provider ID or pharmacy/dispensing ID;
25
(9) the appropriate National Provider Identifier (NPI)
26
or the National Council for Prescription Drug Programs
HB4954
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(NCPDP) provider ID for each filled prescription;
2
(10) the pharmacy BIN (Bank Identification Number)
3
used to route electronic prescription claims to the
4
correct entities for dispensed 340B drugs; and
5
(11) the Pharmacy Control Number (PCN) associated with
6
each fill or refill of a 340B drug.
7
Section 25.
Rulemaking.
The Department shall adopt rules
8
to implement this Act.
9
Section 30.
Repeal.
This Act is repealed on January 1,
10
2031.
11
Section 99.
Effective date.
This Act takes effect upon
12
becoming law.
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