HB 2371

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Full Text of HB2371
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	HB2371 - 104th General Assembly
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		HB2371 Enrolled		LRB104 06098 BAB 16131 b
1    AN ACT concerning regulation.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 1. Short title. This Act may be cited as the
5Patient Access to Pharmacy Protection Act.
6    Section 5. Findings. The General Assembly finds that:
7    (1) It is within the traditional authority of the State to
8regulate the acquisition and delivery of drugs to pharmacies
9and providers.
10    (2) The federal 340B statute is silent on distribution of
11340B-acquired drugs to 340B covered entities and their
12contract pharmacy partners.
13    (3) The State's compelling interest in preserving and
14improving access to health care services requires it to ensure
15that 340B covered entities continue to be allowed to contract
16with pharmacies to receive 340B drugs and dispense them to the
17patients of 340B covered entities in accordance with federal
18law.
19    (4) Addressing accessibility of these life-saving
20medications is a matter of health, safety, and welfare for the
21people of the State of Illinois.
22    Section 10. Definitions. As used in this Act:
		HB2371 Enrolled	- 2 -	LRB104 06098 BAB 16131 b
1    "340B contract pharmacy" means any pharmacy that is under
2contract with a 340B covered entity to dispense 340B drugs on
3behalf of the 340B covered entity and is either (i) located in
4Illinois and qualifies as a pharmacy under Section 3 of the
5Pharmacy Practice Act; or (ii) is located in a state,
6commonwealth, or territory of the United States, other than
7Illinois, and dispenses 340B drugs on behalf of the 340B
8covered entity.
9    "340B covered entity" means an entity in Illinois that
10qualifies as a covered entity under Section 340B of the
11federal Public Health Service Act, 42 U.S.C. 256b(a)(4).
12    "340B drug" means a drug that has been subject to any offer
13for reduced prices by a manufacturer pursuant to 42 U.S.C.
14256b and is purchased by a 340B covered entity.
15    "340B drug discount program" means the program established
16under Section 340B of the federal Public Health Service Act,
1742 U.S.C. 256b.
18    "340B grantee" means an entity in Illinois that qualifies
19as a covered entity under subparagraphs (A)–(K) of paragraph
20(4) of subsection (a) of Section 340B of the federal Public
21Health Service Act, 42 U.S.C. 256b(a)(4)(A)-(K).
22    "Critical Access Hospital" has the meaning given to that
23term in paragraph (4) of subsection (b) of Section 5-5e of the
24Illinois Public Aid Code.
25    "Hospital" means a hospital licensed under the Hospital
26Licensing Act or University of Illinois Hospital Act.
		HB2371 Enrolled	- 3 -	LRB104 06098 BAB 16131 b
1    "Manufacturer" or "Pharmaceutical Manufacturer" has the
2meaning given to the term "manufacturer" in the Wholesale Drug
3Distribution Licensing Act.
4    "Person" includes a natural person, partnership,
5association, corporation, or any other legal business entity.
6"Person" does not include any federal or State government
7entity or body.
8    "Safety-Net Hospital" has the meaning given to that term
9in Section 5-5e.1 of the Illinois Public Aid Code.
10    Section 15. Protection of patient access to pharmacy.
11    (a) No person, including a pharmaceutical manufacturer,
12may deny, restrict, prohibit, condition, or otherwise
13interfere with, either directly or indirectly, the acquisition
14of a 340B drug by, or delivery of a 340B drug to, a 340B
15covered entity or a 340B contract pharmacy authorized to
16receive 340B drugs on behalf of the 340B covered entity unless
17the receipt is prohibited by federal law.
18    (b) No person, including a pharmaceutical manufacturer,
19may impose any restriction on the ability of a 340B covered
20entity to contract with or designate a 340B contract pharmacy,
21including restrictions relating to the number, location,
22ownership, or type of 340B contract pharmacy.
23    (c) No person, including a pharmaceutical manufacturer,
24may require or compel a 340B covered entity or 340B contract
25pharmacy to:
		HB2371 Enrolled	- 4 -	LRB104 06098 BAB 16131 b
1        (1) submit or otherwise provide ingredient cost or
2    pricing data pertinent to 340B drugs unless required by
3    State or federal law;
4        (2) institute requirements in any way relating to how
5    a 340B covered entity manages its inventory of 340B drugs
6    that are not required by a State or federal agency,
7    including requirements relating to the frequency or scope
8    of audits of inventory management systems of a 340B
9    covered entity or a 340B contract pharmacy; or
10        (3) submit data or information that is not required by
11    a State or federal law as a condition for a 340B covered
12    entity, its 340B contract pharmacy, or a location
13    otherwise authorized by a 340B covered entity to receive
14    340B drugs.
15    (d) Each individual transaction, as defined in 21 U.S.C.
16360eee-24, of 340B drugs that is subject to a prohibited act in
17subsections (a) and (b) shall constitute a separate violation
18of this Act.
19    Section 20. Reporting. On or before August 1, 2026 and
20each August 1 thereafter, a 340B covered entity shall submit a
21report to the General Assembly pursuant to this Section. For
22the purposes of this Section, the following covered entities
23are exempt until January 1, 2029 and will report on or before
24August 1, 2029 and each August 1 thereafter: hospitals with
25fewer than 100 licensed beds, Critical Access Hospitals,
		HB2371 Enrolled	- 5 -	LRB104 06098 BAB 16131 b
1Safety-Net Hospitals, and 340B grantees. The report must
2include all of the following for the 340B covered entity's
3340B program:
4        (1) the name of the 340B covered entity submitting the
5    report;
6        (2) a copy of the 340B covered entity's annual 340B
7    program recertification;
8        (3) whether a community benefits plan report is
9    required under Section 20 of the Community Benefits Act
10    and, if so, a copy of the 340B covered entity's community
11    benefits plan report, including a description of the
12    amount of charity care provided by the 340B covered
13    entity;
14        (4) the aggregate acquisition cost for prescription
15    drugs obtained under the 340B program and dispensed or
16    administered to patients;
17        (5) the aggregate payment amount received for all
18    drugs obtained under the 340B program and dispensed or
19    administered to patients;
20        (6) the number of claims for prescription drugs
21    received under the 340B program;
22        (7) the percentage of the 340B covered entity's claims
23    that were for prescription drugs obtained under the 340B
24    program;
25        (8) a description of any adverse 340B program audits
26    within the preceding 12 months; and
		HB2371 Enrolled	- 6 -	LRB104 06098 BAB 16131 b
1        (9) a description of the impact of the 340B program on
2    the patients and the community served by the 340B covered
3    entity.
4    Section 25. Medicaid study.
5    (a) By January 1, 2028, the Department of Healthcare and
6Family Services shall report to the General Assembly on the
7following for the total aggregated covered outpatient drug
8units dispensed or administered in this State for the prior
9calendar year in connection with the medical assistance
10program under the Illinois Public Aid Code, categorized by (i)
11fee-for-service and (ii) each managed care plan:
12        (1) the number of dispensed or administered covered
13    outpatient drug units;
14        (2) the number of dispensed or administered covered
15    outpatient drug units that were subject to a rebate under
16    42 U.S.C. 1396r-8; and
17        (3) a reasonable estimate of net costs or savings to
18    the State's medical assistance program due to 340B covered
19    entity purchases of covered outpatient drug units at 340B
20    pricing.
21    (b) To the extent the Department of Healthcare and Family
22Services lacks information to provide a data element required
23under subsection (a), it shall provide a reasonable estimate
24based on all available information and an explanation of the
25information that it lacks.
		HB2371 Enrolled	- 7 -	LRB104 06098 BAB 16131 b
1    Section 30. 340B prescription drug applicability. Each
2340B covered entity shall dispense or administer 340B drugs
3only when in connection with an outpatient health care service
4received by the patient within the last 18 months.
5    Section 35. Preventing duplication of 340B discounts. Each
6340B covered entity shall develop and maintain a policy that
7ensures it is not placing an order for a 340B drug to replenish
8a prior pharmacy dispense if any other 340B covered entity
9will place an order for a 340B drug to replenish the same prior
10pharmacy dispense. The policy shall also include a process to
11reimburse a manufacturer for any duplicate 340B discount the
12covered entity receives. The policy shall be filed annually
13with the General Assembly.
14    Section 40. Enforcement.
15    (a) The Attorney General is authorized to enforce this Act
16under its general authority under the Attorney General Act.
17    (b) Upon finding a violation of Section 15 of this Act, a
18court may order:
19        (1) temporary, preliminary, or permanent injunctive
20    relief for any act, policy, or practice that violates this
21    Act;
22        (2) money damages to be paid to the 340B covered
23    entity as a result of the violation of this Act;
		HB2371 Enrolled	- 8 -	LRB104 06098 BAB 16131 b
1        (3) the assessment of a civil penalty of up to $1,000
2    for each violation of Section 15; or
3        (4) any other relief.
4    Section 45. Preemption.
5    (a) Nothing in this Act shall be construed or applied to be
6less restrictive than federal law for a person regulated by
7this Act.
8    (b) Nothing in this Act shall be construed or applied in a
9manner that would conflict with:
10        (1) applicable federal law; or
11        (2) other laws of this State if the State law is
12    compatible with applicable federal law.
13    (c) Limited distribution of a drug required under 21
14U.S.C. 355-1 may not to be construed as a violation of this
15Act.
16    Section 97. Severability. If any provision of this Act or
17its application to any person or circumstance is held invalid,
18the invalidity of that provision or application does not
19affect other provisions or applications of this Act that can
20be given effect without the invalid provision or application.
21Each paragraph defining "340B contract pharmacy" in Section 10
22is severable.
23    Section 99. Effective date. This Act takes effect upon
24becoming law.