Arkansas 2025 Regular Session

Arkansas Senate Bill SB140 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	Stricken language would be deleted from and underlined language would be added to present law.
2	2	ANS115 01/29/2025 9:17:24 AM ANS115
3	3	State of Arkansas 1
4	4	95th General Assembly A Bill 2
5	5	Regular Session, 2025 SENATE BILL 140 3
6	6	4
7	7	By: Senator J. Boyd 5
8	8	By: Representative Achor 6
9	9	7
10	10	For An Act To Be Entitled 8
11	11	AN ACT TO MANDATE THE USE OF BIOSIMILAR MEDICINES 9
12	12	UNDER HEALTH BENEFIT PLANS; TO REQUIRE A HEALTHCARE 10
13	13	PROVIDER TO PRESCRIBE BIOSIMILAR MEDICINES; TO 11
14	14	IMPROVE ACCESS TO BIOSIMILAR MEDICINES; AND FOR OTHER 12
15	15	PURPOSES. 13
16	16	14
17	17	15
18	18	Subtitle 16
19	19	TO MANDATE THE USE OF BIOSIMILAR 17
20	20	MEDICINES UNDER HEALTH BENEFIT PLANS; TO 18
21	21	REQUIRE A HEALTHCARE PROVIDER TO 19
22	22	PRESCRIBE BIOSIMILAR MEDICINES; AND TO 20
23	23	IMPROVE ACCESS TO BIOSIMILAR MEDICINES. 21
24	24	22
25	25	BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 23
26	26	24
27	27	SECTION 1. Arkansas Code Title 23, Chapter 79, is amended to add an 25
28	28	additional subchapter to read as follows: 26
29	29	27
30	30	Subchapter 29 — Mandate for Use of Biosimilar Medicines 28
31	31	29
32	32	23-79-2901. Definitions. 30
33	33	As used in this subchapter: 31
34	34	(1) "Beneficiary" means an individual who is entitled to receive 32
35	35	healthcare services under the terms of a health benefit plan; 33
36	36	(2) "Biosimilar medicine" means a biological product that is: 34
37	37	(A) Licensed under 42 U.S.C.§ 262(k), as it existed on 35
38	38	January 1, 2025; and 36 SB140
39	39
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41	41	(B) Not listed as discontinued in the United States Food 1
42	42	and Drug Administration’s Database of Licensed Biological Products, commonly 2
43	43	known as the "Purple Book"; 3
44	44	(3) "Brand drug" means a drug product for which an application 4
45	45	has been approved under 21 U.S.C. § 355(c), as it existed on January 1, 2025, 5
46	46	or a biological product, other than a biosimilar medicine, that is licensed 6
47	47	under 42 U.S.C. § 262(a), as it existed on January 1, 2025; 7
48	48	(4) "Formulary" means: 8
49	49	(A) A list of prescription drug products and biological 9
50	50	products that is developed by a pharmacy and therapeutics committee or other 10
51	51	clinical and pharmacy experts; and 11
52	52	(B) Represents a health benefit plan’s prescription drug 12
53	53	products and biological products approved for use; 13
54	54	(5) "Generic drug" means a drug product: 14
55	55	(A) For which an application has been approved under 21 15
56	56	U.S.C. § 355(j), as it existed on January 1, 2025; and 16
57	57	(B) That has been listed in the United States Food and 17
58	58	Drug Administration’s Approved Drug Products with Therapeutic Equivalence 18
59	59	Evaluations, commonly known as the "Orange Book" as therapeutically 19
60	60	equivalent to a reference listed drug, even if the manufacturer of the drug 20
61	61	product applies a trade name to the drug; 21
62	62	(6)(A) "Health benefit plan" means an individual, blanket, or 22
63	63	group plan, policy, or contract for healthcare services offered, issued, 23
64	64	renewed, delivered, or extended in this state by a healthcare insurer. 24
65	65	(B) “Health benefit plan” includes: 25
66	66	(i) Indemnity and managed care plans; and 26
67	67	(ii) Nonfederal governmental plans as defined in 29 27
68	68	U.S.C. § 1002(32), as it existed on January 1, 2025, including plans 28
69	69	providing health benefits to state and public school employees under § 21 -5-29
70	70	401 et seq. 30
71	71	(C) “Health benefit plan” does not include: 31
72	72	(i) A plan that provides only dental benefits or eye 32
73	73	and vision care benefits; 33
74	74	(ii) A disability income plan; 34
75	75	(iii) A credit insurance plan; 35
76	76	(iv) Insurance coverage issued as a supplement to 36 SB140
77	77
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79	79	liability insurance; 1
80	80	(v) A medical payment under an automobile or 2
81	81	homeowners insurance plan; 3
82	82	(vi) A health benefit plan provided under Arkansas 4
83	83	Constitution, Article 5, § 32, the Workers' Compensation Law, § 11 -9-101 et 5
84	84	seq., or the Public Employee Workers' Compensation Act, § 21 -5-601 et seq.; 6
85	85	(vii) A plan that provides only indemnity for 7
86	86	hospital confinement; 8
87	87	(viii) An accident-only plan; 9
88	88	(ix) A specified disease plan; 10
89	89	(x) A long-term-care-only plan; or 11
90	90	(xi) The Arkansas Medicaid Program; 12
91	91	(7)(A) "Healthcare insurer" means an entity subject to the 13
92	92	insurance laws of this state or the jurisdiction of the Insurance 14
93	93	Commissioner that contracts or offers to contract to provide health insurance 15
94	94	coverage, including without limitation an insurance company, a hospital and 16
95	95	medical service corporation, a health maintenance organization, or a self - 17
96	96	insured governmental or church plan in this state. 18
97	97	(B) "Healthcare insurer" does not include: 19
98	98	(i) An entity that provides only dental benefits or 20
99	99	eye and vision care benefits; or 21
100	100	(ii) The Arkansas Medicaid Program; 22
101	101	(8) "Healthcare provider" means a type of provider that renders 23
102	102	healthcare services to patients for compensation including a doctor of 24
103	103	medicine or another licensed healthcare professional acting within the 25
104	104	provider's licensed scope of practice; 26
105	105	(9) "Reference listed drug" means the listed drug product 27
106	106	identified by the United States Food and Drug Administration as a drug 28
107	107	product upon which an applicant relies in seeking approval of the applicant's 29
108	108	application submitted under 21 U.S.C. § 355(j), as it existed on January 1, 30
109	109	2025; 31
110	110	(10) "Reference product" means a single biological product that 32
111	111	is licensed by the United States Food and Drug Administration under 42 U.S.C. 33
112	112	§ 262(a), as it existed on January 1, 2025, against which a proposed 34
113	113	biosimilar medicine or interchangeable biological product is compared and 35
114	114	listed as a reference product in the United States Food and Drug 36 SB140
115	115
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117	117	Administration’s Database of Licensed Biological Products, commonly known as 1
118	118	the "Purple Book"; and 2
119	119	(11) "Wholesale acquisition cost" means the same as defined in 3
120	120	section 1847A(c)(6)(B) of the Social Security Act, 42 U.S.C. § 1395w -3a, as 4
121	121	it existed on January 1, 2025. 5
122	122	6
123	123	23-79-2902. Mandate to prescribe biosimilar medicines. 7
124	124	(a) If a prescription biological product drug therapy is initiated to 8
125	125	treat a beneficiary enrolled in a health benefit plan and the beneficiary has 9
126	126	not previously been treated with the prescribed biological product drug 10
127	127	therapy, the healthcare provider treating the beneficiary shall prescribe a 11
128	128	biosimilar medicine to the beneficiary, if a biosimilar medicine is 12
129	129	available. 13
130	130	(b) A healthcare provider may appeal the application of this section 14
131	131	for a beneficiary with step therapy protocols under § 23 -79-2101 et seq. 15
132	132	16
133	133	23-79-2903. Formulary. 17
134	134	(a) A health benefit plan shall publish in a manner that is easily 18
135	135	accessible to a beneficiary, a prospective beneficiary, the state, and the 19
136	136	public an up-to-date, accurate, and complete list of all covered drug 20
137	137	products and biological products on the health benefit plan's formulary, 21
138	138	including without limitation: 22
139	139	(1) A tiering structure that has been adopted for the health 23
140	140	benefit plan; and 24
141	141	(2) Any restrictions on the manner in which a drug product or 25
142	142	biological product can be obtained. 26
143	143	(b) A formulary is easily accessible under subsection (a) of this 27
144	144	section if: 28
145	145	(1) The formulary can be viewed on the health benefit plan’s 29
146	146	public website through a clearly identifiable link or tab without requiring 30
147	147	an individual to create or access an account or enter a policy number; and 31
148	148	(2) An individual can easily discern which formulary list 32
149	149	applies to which health benefit plan if a healthcare insurer offers more than 33
150	150	one (1) health benefit plan. 34
151	151	(c) If a change is made to the formulary of a health benefit plan 35
152	152	during the plan year, the easily accessible formulary shall: 36 SB140
153	153
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155	155	(1) Be updated within thirty (30) calendar days; and 1
156	156	(2) Contain, in bold type, the date of the update, with the 2
157	157	updates clearly identifiable. 3
158	158	4
159	159	23-79-2904. Generic drugs. 5
160	160	(a) If a generic drug is marketed pursuant to such approval, and has a 6
161	161	wholesale acquisition cost that is less than the wholesale acquisition cost 7
162	162	of the reference listed drug on the generic drug’s initial date of marketing, 8
163	163	then a health benefit plan that provides coverage for the generic drug’s 9
164	164	reference listed drug at the time of the generic drug’s marketing date shall: 10
165	165	(1) Immediately make the generic drug available on the formulary 11
166	166	with more favorable cost sharing, including without limitation actual out -of-12
167	167	pocket costs, relative to the reference listed drug; and 13
168	168	(2) Not impose: 14
169	169	(A) A prior authorization, a step therapy requirement, or 15
170	170	other limitation on coverage of a generic drug for which formulary placement 16
171	171	is required under this section; or 17
172	172	(B) A restriction on a pharmacy through which a 18
173	173	beneficiary may obtain the generic drug that makes it more difficult for the 19
174	174	beneficiary to obtain coverage of or access to the generic drug than to 20
175	175	obtain coverage of or access to the reference listed drug. 21
176	176	(b) This section shall remain in force as long as the wholesale 22
177	177	acquisition cost of a generic drug is lower than the wholesale acquisition 23
178	178	cost of the generic drug's reference listed drug. 24
179	179	25
180	180	23-79-2905. Biosimilar medicines. 26
181	181	(a) If a biosimilar medicine is marketed pursuant to such licensure, 27
182	182	and has a wholesale acquisition cost that is less than the wholesale 28
183	183	acquisition cost of the reference product of the biosimilar medicine on the 29
184	184	initial date of marketing, then a health benefit plan that provide coverage 30
185	185	for the biosimilar medicine’s reference product at the time of the biosimilar 31
186	186	medicine’s marketing date shall: 32
187	187	(1) Immediately make at least one (1) biosimilar medicine 33
188	188	available on the formulary on a tier with more favorable cost sharing, 34
189	189	including actual out -of-pocket costs, relative to the reference product; and 35
190	190	(2) Not impose: 36 SB140
191	191
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193	193	(A) A prior authorization, a step therapy requirement, or 1
194	194	other limitation on coverage of a biosimilar medicine for which formulary 2
195	195	placement is required under this section; or 3
196	196	(B) A restriction on a pharmacy through which a 4
197	197	beneficiary may obtain the biosimilar medicine that makes it more difficult 5
198	198	for a beneficiary to obtain coverage of or access to the biosimilar medicine 6
199	199	than to obtain coverage of or access to the reference product. 7
200	200	(b) This section shall remain in force as long as the wholesale 8
201	201	acquisition cost of a biosimilar medicine is lower than the wholesale 9
202	202	acquisition cost of the biosimilar medicine's reference product. 10
203	203	11
204	204	23-79-2906. Purpose and construction of subchapter. 12
205	205	(a) A health benefit plan is not required under this subchapter to: 13
206	206	(1) Continue providing coverage for a brand drug after a generic 14
207	207	drug or biosimilar medicine is approved or licensed, as applicable, and 15
208	208	marketed; or 16
209	209	(2) Provide coverage for a brand drug, generic drug, biological 17
210	210	product, or biosimilar medicine if the pharmacy and therapeutics committee or 18
211	211	the clinical and pharmacy experts that develop the health benefit plan’s 19
212	212	formulary determines that the brand drug, generic drug, biological product, 20
213	213	or biosimilar medicine is no longer medically appropriate or cost -effective. 21
214	214	(b) The application of this subchapter shall not interfere with or 22
215	215	prevent a pharmacy from the practice of pharmacy as defined in § 17 -92-101. 23
216	216	24
217	217	23-79-2907. Rules. 25
218	218	(a) The Insurance Commissioner may promulgate rules necessary to 26
219	219	implement this subchapter. 27
220	220	(b) The State Board of Finance may promulgate rules necessary to 28
221	221	implement this subchapter that may apply to the State and Public School Life 29
222	222	and Health Insurance Program. 30
223	223	31
224	224	SECTION 2. DO NOT CODIFY. Effective date. This act is effective on 32
225	225	and after January 1, 2026. 33
226	226	34
227	227	35
228	228	36