North Carolina 2025-2026 Regular Session

North Carolina Senate Bill S517 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		GENERAL ASSEMBLY OF NORTH CAROLINA
2	2		SESSION 2025
3		-	S 1
4		-	SENATE BILL 517
	3	+	S D
	4	+	SENATE BILL DRS15184-MG-96
	5	+
5	6
6	7
7	8		Short Title: Fair Pricing & Trnspncy/340B Covered Entities. (Public)
8	9		Sponsors: Senators Galey, Burgin, and Sawrey (Primary Sponsors).
9		-	Referred to: ~~Rules and Operations of the Senate~~
10		-	~~March 26, 2025~~
11		-	~~S517 -v-1~~
	10	+	Referred to:
	11	+
	12	+	DRS15184 -MG-96
12	13		A BILL TO BE ENTITLED 1
13	14		AN ACT ESTABLISHING FAIR PRICING AND TRANSPARENCY REQUIREMENTS FOR 2
14	15		340B COVERED ENTITIES. 3
15	16		The General Assembly of North Carolina enacts: 4
16	17		SECTION 1.(a) Chapter 131E of the General Statutes is amended by adding a new 5
17	18		Article to read: 6
18	19		"Article 11C. 7
19	20		"340B Covered Entities. 8
20	21		"Part 1. Fair Pricing of 340B Drugs by Hospitals. 9
21	22		"§ 131E-214.50. Definitions. 10
22	23		The following definitions apply in this Part: 11
23	24		(1) 340B drug. – A drug that meets the definition of a "covered drug" under 42 12
24	25		U.S.C. § 256b(b)(2). 13
25	26		(2) 340B Program. – The federal 340B Drug Pricing Program authorized under 14
26	27		42 U.S.C. § 256b and 42 C.F.R. Part 10, as both are from time to time 15
27	28		amended. 16
28	29		(3) Acquisition cost. – The amount paid by a covered entity to acquire a 340B 17
29	30		drug. 18
30	31		(4) Covered entity. – Any entity described in 42 U.S.C. § 256b(a)(4)(L) or 42 19
31	32		U.S.C. § 256b(a)(4)(M). 20
32	33		"§ 131E-214.52. Fair pricing of 340B drugs by hospitals. 21
33	34		A covered entity that acquires a 340B drug for a discounted price under the 340B Program 22
34	35		shall not accept an amount greater than the acquisition cost for the 340B drug as payment for 23
35	36		dispensing, administering, or otherwise delivering the 340B drug to a patient. 24
36	37		"§ 131E-214.54. Violations constitute unfair or deceptive trade practice. 25
37	38		Any violation of this Part constitutes an unfair or deceptive trade practice in violation of 26
38	39		G.S. 75-1.1 and is subject to all of the enforcement and penalty provisions of an unfair or 27
39	40		deceptive trade practice under Article 1 of Chapter 75 of the General Statutes. 28
40	41		"Part 2. 340B Covered Entity Transparency. 29
41	42		"§ 131E-214.60. Definitions. 30
42	43		The following definitions apply in this Part: 31
43	44		(1) 340B drug. – A covered outpatient drug that has been subject to any offer for 32
44	45		reduced prices by a manufacturer pursuant to 42 U.S.C. § 256b, and is 33
45	46		purchased by a covered entity. 34
46	47		(2) 340B pricing. – Any price offered by a manufacturer to a covered entity for a 35
47		-	covered outpatient drug pursuant to 42 U.S.C. § 256b. 36 General Assembly Of North Carolina Session 2025
48		-	Page 2 Senate Bill 517-First Edition
	48	+	covered outpatient drug pursuant to 42 U.S.C. § 256b. 36
	49	+	FILED SENATE
	50	+	Mar 25, 2025
	51	+	S.B. 517
	52	+	PRINCIPAL CLERK General Assembly Of North Carolina Session 2025
	53	+	Page 2 DRS15184-MG-96
49	54		(3) 340B Program. – The federal 340B Drug Pricing Program authorized under 1
50	55		42 U.S.C. § 256b and 42 C.F.R. Part 10, as both are from time to time 2
51	56		amended. 3
52	57		(4) Charity care. – The costs reported on Form CMS-2552-10, Worksheet S–10, 4
53	58		Line 23 or any successor form. 5
54	59		(5) Covered entity. – A covered entity, as defined in 42 U.S.C. § 256b(a)(4). 6
55	60		(6) Covered outpatient drug. – A covered outpatient drug, as defined in 42 U.S.C. 7
56	61		§ 1396r-8(k)(2). 8
57	62		"§ 131E-214.62. Annual reporting requirements. 9
58	63		(a) Annually by October 1, each covered entity shall report to the Department, in the form 10
59	64		and manner required by the Department, the following information regarding the preceding 11
60	65		calendar year for the covered entity and each offsite outpatient facility, clinic, eligible offsite 12
61	66		location, or other site associated with the covered entity: 13
62	67		(1) Delineated by form of insurance or payor type, including, but not limited to, 14
63	68		Medicaid, Medicare, commercial insurance, and uninsured: 15
64	69		a. Aggregate acquisition cost paid for all 340B drugs. 16
65	70		b. Aggregate payments received by individuals, insurers, or payors for 17
66	71		all 340B drugs. For the purpose of this sub-subdivision, aggregate 18
67	72		payments include cost-sharing amounts. 19
68	73		c. The total number of prescriptions and what percentage of the covered 20
69	74		entity's prescriptions were filled with 340B drugs. 21
70	75		(2) Attestation as to whether the covered entity did any of the following: 22
71	76		a. Passed on 340B Program discounts to patients of the covered entity in 23
72	77		the form of lower cost-sharing for 340B drugs at the point of 24
73	78		dispensing or administration. 25
74	79		b. Provided a sliding fee scale for 340B drugs for patients whose family 26
75	80		income is less than two hundred percent (200%) of the federal poverty 27
76	81		level established pursuant to 42 U.S.C. § 9902. 28
77	82		(3) Total operating costs of the covered entity, including itemized costs, for each 29
78	83		of the following: 30
79	84		a. Implementation of the policies described in subdivision (2) of this 31
80	85		subsection, if applicable. 32
81	86		b. Charity care. 33
82	87		(4) Total payments made by the covered entity or any agent of the covered entity 34
83	88		to any of the following: 35
84	89		a. Any pharmacies under contract with the covered entity to dispense 36
85	90		340B drugs for 340B program-related services and other functions. 37
86	91		b. Third-party administrators, including pharmacy benefits managers, for 38
87	92		managing any components of the covered entity's participation in the 39
88	93		340B Program. 40
89	94		c. Any other third parties in connection with 340B program-related 41
90	95		compliance, legal, educational, or administrative costs. 42
91	96		(5) Total number of pharmacies under contract with the covered entity to dispense 43
92	97		340B drugs, and among those, the following information: 44
93	98		a. The number of pharmacies located out-of-state and the states in which 45
94	99		the out-of-state pharmacies are located. 46
95	100		b. Total number of prescriptions and orders for 340B drugs filled by the 47
96	101		covered entity and by each offsite outpatient facility associated with 48
97	102		the covered entity, and the percentage of such prescriptions or orders 49
98	103		that were filled at such pharmacies, delineated by in-State and 50
99	104		out-of-state pharmacies. 51 General Assembly Of North Carolina Session 2025
100		-	~~Senate Bill 517-First Edition~~ Page 3
	105	+	DRS15184-MG-96 Page 3
101	106		c. Total remuneration paid to or retained by such pharmacies or their 1
102	107		affiliates for any 340B program-related services performed on behalf 2
103	108		of the covered entity and each offsite outpatient facility associated 3
104	109		with the covered entity. 4
105	110		d. The percentage change in remuneration described in sub-subdivision 5
106	111		(4)c. of this subsection for the preceding calendar year compared to 6
107	112		the year before that. 7
108	113		(b) An officer of the covered entity shall certify to the completeness and accuracy of the 8
109	114		report submitted pursuant to subsection (a) of this section. 9
110	115		"§ 131E-214.64. Posting of annual reports. 10
111	116		The Department shall make all the reports received by covered entities pursuant to 11
112	117		G.S. 131E-214.62 available to the public on the Department's internet website." 12
113	118		SECTION 1.(b) Part 1 of Article 11C of Chapter 131E of the General Statutes, as 13
114	119		enacted by this section, applies to any covered drug, as defined by 42 U.S.C. § 256b(b)(2), that 14
115	120		is dispensed, administered, or otherwise delivered to a patient by a covered entity on or after the 15
116	121		date this act becomes law. As used in this subsection, the term "covered entity" has the same 16
117	122		meaning as in G.S. 131E-214.50. 17
118	123		SECTION 1.(c) Covered entities subject to Part 2 of Article 11C of Chapter 131E 18
119	124		of the General Statutes, as enacted by this section, shall submit the first report due under 19
120	125		G.S. 131E-214.62 by October 1, 2026. 20
121	126		SECTION 2. This act is effective when it becomes law. 21