Tennessee 2025-2026 Regular Session

Tennessee Senate Bill SB1414 Compare Versions

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

Old	New	Differences
1	1
2	2	HOUSE BILL 1242
3	3	By Helton-Haynes
4	4
5	5	SENATE BILL 1414
6	6	By Briggs
7	7
8	8
9	9	SB1414
10	10	002710
11	11	- 1 -
12	12
13	13	AN ACT to amend Tennessee Code Annotated, Title 47,
14	14	Chapter 18 and Title 56, relative to 340B entities.
15	15
16	16	BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
17	17	SECTION 1. Tennessee Code Annotated, Section 56-7-3119, is amended by deleting
18	18	subsection (d) and substituting:
19	19	(d) A drug manufacturer or their agent or affiliate, shall not, either directly or
20	20	indirectly:
21	21	(1) Deny, restrict, prohibit, discriminate against, or otherwise limit the
22	22	acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity or
23	23	other location that is under contract with, or otherwise authorized by, a 340B
24	24	entity to receive 340B drugs on behalf of the 340B entity unless such receipt is
25	25	prohibited by the United States Department of health and human services or
26	26	applicable state law;
27	27	(2) Impose additional requirements or limitations on a 340B entity,
28	28	including requiring the submission of any health information, claims or utilization
29	29	data, purchasing data, payment data, or other data as a condition for allowing the
30	30	acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity or
31	31	other location that is under contract with or otherwise authorized by a 340B entity
32	32	to receive 340B drugs on behalf of the 340B entity unless such data submission
33	33	is explicitly required by the United States department of health and human
34	34	services or applicable state law;
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36	36
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38	38
39	39	(3) Require a 340B entity to reverse, resubmit, or clarify a claim after the
40	40	initial adjudication unless these actions are in the normal course of business and
41	41	not related to the 340B program;
42	42	(4) Impose any requirements relating to the number of 340B entities or
43	43	their contract pharmacies or inventory management systems of 340B drugs,
44	44	unless such requirement is required by the United States department of health
45	45	and human services or applicable state law;
46	46	(5) Impose any requirement relating to the frequency, duration, or scope
47	47	of audits that are not imposed on pharmacies or providers that are not 340B
48	48	entities;
49	49	(6) Impose requirements relating to accreditation, recertification,
50	50	credentialing, or recredentialing that are not imposed on pharmacies or providers
51	51	that are not 340B entities; or
52	52	(7) Impose any requirement determined by the commissioner to interfere
53	53	with the ability of a 340B entity to access discounts provided under the 340B
54	54	program.
55	55	(e) A person or entity that contracts with a 340B entity to dispense 340B drugs
56	56	or to administer, or otherwise to consult for the purposes of facilitating, a 340B entity's
57	57	participation in the 340B program shall:
58	58	(1) Not interfere with, prohibit, restrict, or limit a 340B entity's contracts or
59	59	prospective business relationships with another person or entity;
60	60	(2) Not deny, restrict, prohibit, or otherwise interfere with a 340B entity's
61	61	choice of 340B drugs acquired, delivered, or otherwise distributed under
62	62	subsection (b); or
63	63
64	64
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66	66
67	67	(3) Exclude claims from 340B entities which would result in a net loss to
68	68	the covered entity.
69	69	(f)
70	70	(1) A violation of subsection (d) constitutes a violation of § 56-8-104;
71	71	provided, that a civil penalty may be assessed in the amount of fifty thousand
72	72	dollars ($50,000) per violation.
73	73	(2) A violation of subsection (d) constitutes a violation of § 47-18-104;
74	74	provided, that a civil penalty may be assessed in the amount of fifty thousand
75	75	dollars ($50,000) per violation.
76	76	(3) Each package of 340B drugs applicable to a violation of subsection
77	77	(d) constitutes a separate violation.
78	78	(4) A violation of subsection (d) may be jointly or separately enforced by
79	79	the commissioner or attorney general and reporter.
80	80	(g) This section must not be construed or applied to be in conflict with or less
81	81	restrictive than:
82	82	(1) Applicable federal law and regulations, including limited distribution of
83	83	a drug required under 21 U.S.C. § 355-1; or
84	84	(2) Another law of this state if the state law is compatible with applicable
85	85	federal law.
86	86	(h) As used in this section:
87	87	(1) "340B drug" means a drug that is a covered outpatient drug within the
88	88	meaning of 42 U.S.C. § 256b; is eligible for any offer for reduced prices by a
89	89	manufacturer under 42 U.S.C. § 256b(a)(1); and is purchased by a 340B entity or
90	90	would have been purchased by a 340B entity but for a restriction or limitation
91	91	described in subsection (b);
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95	95
96	96	(2) "340B entity" means a covered entity participating in the federal 340B
97	97	drug discount program, as defined in section 340B of the Public Health Service
98	98	Act, 42 U.S.C. § 256b, including the entity's pharmacy or pharmacies, or any
99	99	pharmacy or pharmacies under contract with the 340B entity to dispense drugs
100	100	on behalf of the 340B entity;
101	101	(3) "Claim" means a request from a 340B entity to be reimbursed for the
102	102	cost of filling, refilling, or administering a prescription drug or for providing a
103	103	medical supply or device;
104	104	(4) "Health information" means any information, including demographic
105	105	information collected from an individual or a group of individuals, that:
106	106	(A) Is created or received by a healthcare provider, pharmacy,
107	107	health plan, employer, or healthcare clearinghouse; and
108	108	(B) Relates to the past, present, or future physical or mental
109	109	health or condition of an individual, the provision of health care to an
110	110	individual, or the past, present, or future payment for the provision of
111	111	health care to an individual;
112	112	(5) "Health insurance issuer" has the same meaning as defined in § 56-
113	113	2-125;
114	114	(6) "Managed health insurance issuer" has the same meaning as defined
115	115	in § 56-32-128;
116	116	(7) "National drug code number" means the unique national drug code
117	117	number that identifies a specific approved drug, its manufacturer, and its
118	118	package presentation; and
119	119	(8) "Package" has the same meaning as defined in 21 U.S.C. §
120	120	360eee(11)(A).
121	121
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125	125	SECTION 2. Tennessee Code Annotated, Section 56-8-104, is amended by adding the
126	126	following new subdivision:
127	127	(24) A violation of § 56-7-3119(d).
128	128	SECTION 3. Tennessee Code Annotated, Section 47-18-104(b), is amended by adding
129	129	the following new subdivision:
130	130	(68) Violating § 56-7-3119(d).
131	131	SECTION 4. If any provision of this act or its application to any person or circumstance
132	132	is held invalid, then the invalidity does not affect other provisions or applications of the act that
133	133	can be given effect without the invalid provision or application, and to that end, the provisions of
134	134	this act are severable.
135	135	SECTION 5. This act takes effect July 1, 2025, the public welfare requiring it.