Shown verbatim: the complete text as captured from the official PDF posted by the Arkansas General Assembly, fetched 2026-07-23. Page and line markers are part of the official record; nothing is edited or removed. The official bill page.
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1 State of Arkansas As Engrossed: S2/5/25 S3/10/25
2 95th General Assembly
A Bill
3 Regular Session, 2025 SENATE BILL 140
4
5 By: Senator J. Boyd
6 By: Representative Achor
7
8 For An Act To Be Entitled
9 AN ACT TO MANDATE THE USE OF BIOSIMILAR MEDICINES
10 UNDER HEALTH BENEFIT PLANS; TO REQUIRE A HEALTHCARE
11 PROVIDER TO PRESCRIBE BIOSIMILAR MEDICINES; TO
12 IMPROVE ACCESS TO BIOSIMILAR MEDICINES; AND FOR OTHER
13 PURPOSES.
14
15
16 Subtitle
17 TO MANDATE THE USE OF BIOSIMILAR
18 MEDICINES UNDER HEALTH BENEFIT PLANS; TO
19 REQUIRE A HEALTHCARE PROVIDER TO
20 PRESCRIBE BIOSIMILAR MEDICINES; AND TO
21 IMPROVE ACCESS TO BIOSIMILAR MEDICINES.
22
23 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS:
24
25 SECTION 1. Arkansas Code Title 23, Chapter 79, is amended to add an
26 additional subchapter to read as follows:
27
28 Subchapter 29 -- Mandate for Use of Biosimilar Medicines
29
30 23-79-2901. Definitions.
31 As used in this subchapter:
32 (1) "Beneficiary" means an individual who is entitled to receive
33 healthcare services under the terms of a health benefit plan;
34 (2) "Biosimilar medicine" means a biological product that is:
35 (A) Licensed under 42 U.S.C.� 262(k), as it existed on
36 January 1, 2025; and
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1 (B) Not listed as discontinued in the United States Food
2 and Drug Administration's Database of Licensed Biological Products, commonly
3 known as the "Purple Book";
4 (3) "Brand drug" means a drug product for which an application
5 has been approved under 21 U.S.C. � 355(c), as it existed on January 1, 2025,
6 or a biological product, other than a biosimilar medicine, that is licensed
7 under 42 U.S.C. � 262(a), as it existed on January 1, 2025;
8 (4) "Formulary" means:
9 (A) A list of prescription drug products and biological
10 products that is developed by a pharmacy and therapeutics committee or other
11 clinical and pharmacy experts; and
12 (B) Represents a health benefit plan's prescription drug
13 products and biological products approved for use;
14 (5) "Generic drug" means a drug product:
15 (A) For which an application has been approved under 21
16 U.S.C. � 355(j), as it existed on January 1, 2025; and
17 (B) That has been listed in the United States Food and
18 Drug Administration's Approved Drug Products with Therapeutic Equivalence
19 Evaluations, commonly known as the "Orange Book" as therapeutically
20 equivalent to a reference listed drug, even if the manufacturer of the drug
21 product applies a trade name to the drug;
22 (6)(A) "Health benefit plan" means an individual, blanket, or
23 group plan, policy, or contract for healthcare services offered, issued,
24 renewed, delivered, or extended in this state by a healthcare insurer.
25 (B) "Health benefit plan" includes:
26 (i) Indemnity and managed care plans; and
27 (ii) Nonfederal governmental plans as defined in 29
28 U.S.C. � 1002(32), as it existed on January 1, 2025, including plans
29 providing health benefits to state and public school employees under � 21-5-
30 401 et seq.
31 (C) "Health benefit plan" does not include:
32 (i) A plan that provides only dental benefits or eye
33 and vision care benefits;
34 (ii) A disability income plan;
35 (iii) A credit insurance plan;
36 (iv) Insurance coverage issued as a supplement to
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1 liability insurance;
2 (v) A medical payment under an automobile or
3 homeowners insurance plan;
4 (vi) A health benefit plan provided under Arkansas
5 Constitution, Article 5, � 32, the Workers' Compensation Law, � 11-9-101 et
6 seq., or the Public Employee Workers' Compensation Act, � 21-5-601 et seq.;
7 (vii) A plan that provides only indemnity for
8 hospital confinement;
9 (viii) An accident-only plan;
10 (ix) A specified disease plan;
11 (x) A long-term-care-only plan; or
12 (xi) The Arkansas Medicaid Program;
13 (7)(A) "Healthcare insurer" means an entity subject to the
14 insurance laws of this state or the jurisdiction of the Insurance
15 Commissioner that contracts or offers to contract to provide health insurance
16 coverage, including without limitation an insurance company, a hospital and
17 medical service corporation, a health maintenance organization, or a self-
18 insured governmental or church plan in this state.
19 (B) "Healthcare insurer" does not include:
20 (i) An entity that provides only dental benefits or
21 eye and vision care benefits; or
22 (ii) The Arkansas Medicaid Program;
23 (8) "Healthcare provider" means a type of provider that renders
24 healthcare services to patients for compensation including a doctor of
25 medicine or another licensed healthcare professional acting within the
26 provider's licensed scope of practice;
27 (9) "Limited distribution drug" means a prescription medication
28 that is restricted by a pharmaceutical manufacturer to a limited number of
29 specialty pharmacies due to the prescription medication's:
30 (A) Complex use, including special handling, monitoring,
31 or administration;
32 (B) High cost; or
33 (C) Safety concerns;
34 (10) "Reference listed drug" means the listed drug product
35 identified by the United States Food and Drug Administration as a drug
36 product upon which an applicant relies in seeking approval of the applicant's
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1 application submitted under 21 U.S.C. � 355(j), as it existed on January 1,
2 2025;
3 (11) "Reference product" means a single biological product that
4 is licensed by the United States Food and Drug Administration under 42 U.S.C.
5 � 262(a), as it existed on January 1, 2025, against which a proposed
6 biosimilar medicine or interchangeable biological product is compared and
7 listed as a reference product in the United States Food and Drug
8 Administration's Database of Licensed Biological Products, commonly known as
9 the "Purple Book"; and
10 (12) "Wholesale acquisition cost" means the same as defined in
11 section 1847A(c)(6)(B) of the Social Security Act, 42 U.S.C. � 1395w-3a, as
12 it existed on January 1, 2025.
13
14 23-79-2902. Formulary.
15 (a) A health benefit plan shall publish in a manner that is easily
16 accessible to a beneficiary, a prospective beneficiary, the state, and the
17 public an up-to-date, accurate, and complete list of all covered drug
18 products and biological products on the health benefit plan's formulary,
19 including without limitation:
20 (1) A tiering structure that has been adopted for the health
21 benefit plan; and
22 (2) Any restrictions on the manner in which a drug product or
23 biological product can be obtained.
24 (b) A formulary is easily accessible under subsection (a) of this
25 section if:
26 (1) The formulary can be viewed on the health benefit plan's
27 public website through a clearly identifiable link or tab without requiring
28 an individual to create or access an account or enter a policy number; and
29 (2) An individual can easily discern which formulary list
30 applies to which health benefit plan if a healthcare insurer offers more than
31 one (1) health benefit plan.
32 (c) If a change is made to the formulary of a health benefit plan
33 during the plan year, the easily accessible formulary shall:
34 (1) Be updated within thirty (30) calendar days; and
35 (2) Contain, in bold type, the date of the update, with the
36 updates clearly identifiable.
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1
2 23-79-2903. Generic drugs.
3 (a) If a generic drug is marketed pursuant to such approval, and has a
4 wholesale acquisition cost that is less than the wholesale acquisition cost
5 of the reference listed drug on the generic drug's initial date of marketing,
6 then a health benefit plan that provides coverage for the generic drug's
7 reference listed drug at the time of the generic drug's marketing date shall:
8 (1) Within a reasonable amount of time make the generic drug
9 available on the formulary with more favorable cost sharing, including
10 without limitation actual out-of-pocket costs, relative to the reference
11 listed drug; and
12 (2) Not impose:
13 (A) A prior authorization, a step therapy requirement, or
14 other limitation on coverage of a generic drug for which formulary placement
15 is required under this section with the exception of limited distribution
16 drugs; or
17 (B) A restriction on a pharmacy through which a
18 beneficiary may obtain the generic drug that makes it more difficult for the
19 beneficiary to obtain coverage of or access to the generic drug than to
20 obtain coverage of or access to the reference listed drug.
21 (b) This section shall remain in force as long as the wholesale
22 acquisition cost of a generic drug is lower than the wholesale acquisition
23 cost of the generic drug's reference listed drug.
24
25 23-79-2904. Biosimilar medicines.
26 (a) If a biosimilar medicine is marketed pursuant to such licensure,
27 and has a wholesale acquisition cost that is less than the wholesale
28 acquisition cost of the reference product of the biosimilar medicine on the
29 initial date of marketing, then a health benefit plan that provide coverage
30 for the biosimilar medicine's reference product at the time of the biosimilar
31 medicine's marketing date shall:
32 (1) Within a reasonable amount of time make at least one (1)
33 biosimilar medicine available on the formulary on a tier with more favorable
34 cost sharing, including actual out-of-pocket costs, relative to the reference
35 product; and
36 (2) Not impose:
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1 (A) A prior authorization, a step therapy requirement, or
2 other limitation on coverage of a biosimilar medicine for which formulary
3 placement is required under this section with the exception of limited
4 distribution drugs; or
5 (B) A restriction on an accredited pharmacy through which
6 a beneficiary may obtain the biosimilar medicine that makes it more difficult
7 for a beneficiary to obtain coverage of or access to the biosimilar medicine
8 than to obtain coverage of or access to the reference product.
9 (b) This section shall remain in force as long as the wholesale
10 acquisition cost of a biosimilar medicine is lower than the wholesale
11 acquisition cost of the biosimilar medicine's reference product.
12
13 23-79-2905. Purpose and construction of subchapter.
14 (a) A health benefit plan is not required under this subchapter to:
15 (1) Continue providing coverage for a brand drug after a generic
16 drug or biosimilar medicine is approved or licensed, as applicable, and
17 marketed; or
18 (2) Provide coverage for a brand drug, generic drug, biological
19 product, or biosimilar medicine if the pharmacy and therapeutics committee or
20 the clinical and pharmacy experts that develop the health benefit plan's
21 formulary determines that the brand drug, generic drug, biological product,
22 or biosimilar medicine is no longer medically appropriate or cost-effective.
23 (b) The application of this subchapter shall not interfere with or
24 prevent a pharmacy from the practice of pharmacy as defined in � 17-92-101.
25
26 23-79-2906. Rules.
27 (a) The Insurance Commissioner may promulgate rules necessary to
28 implement this subchapter.
29 (b) The State Board of Finance may promulgate rules necessary to
30 implement this subchapter that may apply to the State and Public School Life
31 and Health Insurance Program.
32
33 SECTION 2. DO NOT CODIFY. Effective date. This act is effective on
34 and after January 1, 2026.
35
36 /s/J. Boyd
6 03-10-2025 10:27:34 ANS115Every fact on this page links to its source, starting with the official bill record.