Hawaii 2022 Regular Session

Hawaii House Bill HB14 Compare Versions

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

Old	New	Differences
1	1	HOUSE OF REPRESENTATIVES H.B. NO. 14 THIRTY-FIRST LEGISLATURE, 2021 STATE OF HAWAII A BILL FOR AN ACT relating to prescription drugs. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
2	2
3	3	HOUSE OF REPRESENTATIVES H.B. NO. 14
4	4	THIRTY-FIRST LEGISLATURE, 2021
5	5	STATE OF HAWAII
6	6
7	7	HOUSE OF REPRESENTATIVES
8	8
9	9	H.B. NO.
10	10
11	11	14
12	12
13	13	THIRTY-FIRST LEGISLATURE, 2021
14	14
15	15
16	16
17	17	STATE OF HAWAII
18	18
19	19
20	20
21	21
22	22
23	23
24	24
25	25
26	26
27	27
28	28
29	29
30	30
31	31	A BILL FOR AN ACT
32	32
33	33
34	34
35	35
36	36
37	37	relating to prescription drugs.
38	38
39	39
40	40
41	41
42	42
43	43	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
44	44
45	45
46	46
47	47	SECTION 1. The Hawaii Revised Statutes is amended by adding a new chapter to be appropriately designated and to read as follows: "Chapter wholesale importation of prescription drugs § -1 Wholesale prescription drug importation program; established. The department of health shall administer in consultation with relevant state stakeholders and federal offices and agencies, a wholesale prescription drug importation program that will meet the requirements of title 21 United States Code section 384, including requirements regarding safety and cost savings. In developing a wholesale prescription drug importation program for federal certification, the department of health shall ensure that: (1) The department of health either becomes a licensed wholesaler or licenses an entity to become a wholesaler for the purpose of seeking federal certification and approval to import safe prescription drugs that will provide savings to consumers; (2) The program uses Canadian suppliers who are regulated under the appropriate Canadian laws; (3) The program implements a process to sample the purity, chemical composition, and potency of imported prescription drugs; (4) The program only imports prescription drugs that are expected to generate substantial savings for consumers; (5) Imported prescription drugs shall not be distributed, dispensed, or sold outside of the State; (6) Pharmacies and health care providers shall not charge individual consumers and health plans more than the actual acquisition cost of the dispensed, imported prescription drug; (7) Health plan payments of the prescription drug component of pharmacy and health care provider billing are not more than the health plan's share of the actual acquisition cost of the dispensed, imported prescription drug; (8) Participating health plans update their formularies and claims payment systems with the prescription drugs that are provided through the wholesale prescription drug importation program; (9) Participating health plans shall not base patient cost-sharing upon more than the patient's share of the actual acquisition cost of the dispensed, imported prescription drug; (10) Participating health plans demonstrate to the satisfaction of the director of health that savings on imported prescription drugs are reflected in premiums; (11) The profit margin of any participating wholesaler or distributor of imported prescription drugs is limited to a specified amount, to be established by the department of health; (12) The program shall not import generic prescription drugs that would violate federal patent laws for federally-branded prescription drugs; (13) The program complies with the requirements of title 21 United States Code sections 360eee and 360eee-1, pertaining to the track and trace requirements as enacted in Title II of the Drug Quality and Security Act (Public Law 113-54) to the extent practical and feasible before imported prescription drugs come into possession of the state wholesaler, and complies fully after imported prescription drugs are in the possession of the state wholesaler; (14) The program is adequately financed through a fee on each prescription or other appropriate approach, but the size of the fee shall not jeopardize significant consumer savings; and (15) The program shall be audited regularly to ensure that: (A) The department of health determines the most cost-effective prescription drugs to include on an ongoing basis in the prescription drug importation program; (B) The department of health selects Canadian suppliers of high quality and performance that are in full compliance with Canadian law and regulation; (C) Imported prescription drugs under the state program are not shipped, sold, or dispensed outside the State once in the possession of the State; (D) Imported prescription drugs are pure, unadulterated, potent, and safe; (E) Participating pharmacies and administering providers do not charge more than the actual acquisition cost to any consumer or any participating health plan; (F) Participating health plan formularies and claims processing systems remain updated with all relevant aspects of the prescription drug importation program; (G) Participating health plans base patient coinsurance and other cost sharing upon the patient's share of the actual acquisition cost of covered, imported prescription drugs; (H) Participating health plans reimburse participating pharmacies and administering providers the health plan's share of actual acquisition cost for dispensed, imported prescription drugs; (I) The program is adequately financed to support all administrative functions while generating significant consumer savings; (J) The program does not put consumers at higher risk than if the program did not exist; and (K) The program continues to provide consumers in the State with substantial savings on prescription drugs. § -2 Monitoring for anti-competitive behavior. The department of health shall coordinate with the department of the attorney general to identify the potential for anti-competitive behavior in industries that would be affected by a program of wholesale prescription drug importation. § -3 Submission of request for federal certification and approval. The department of health shall submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the State's wholesale prescription drug importation program. § -4 Implementation and additional administrative requirements. Upon certification and approval by the Secretary of the United States Department of Health and Human Services, the department of health shall begin implementation of the wholesale prescription drug importation program and shall begin to operate the program within six months of the date of the Secretary's certification. As part of the implementation process, the department of health shall: (1) Become licensed as a wholesaler or license an entity to become a wholesaler; (2) Contract with a state-licensed distributor or distributors; (3) Contract with a licensed or regulated Canadian supplier or suppliers; (4) Engage health plans, employers, pharmacies, providers, and consumers; (5) Develop a registration process for participating health plans, pharmacies, and administering providers; (6) Create a publicly available list of prices of imported prescription drugs that will be available to all participating entities and consumers; (7) Create an outreach and marketing plan to generate program awareness; (8) Create and staff a hotline to respond to inquiries from consumers, employers, plans, pharmacies, and providers; (9) Establish an audit process and a two-year audit work plan cycle; and (10) Conduct any other activities necessary to the successful implementation, as determined by the department of health. § -5 Report to the governor and the legislature. The department of health shall provide an annual report to the governor and the legislature that includes: (1) The prescription drugs covered in the wholesale prescription drug importation program; (2) The number of participating pharmacies, providers, and health plans; (3) The number of prescriptions dispensed under the program in the reporting period; (4) The estimated savings to consumers, health plans, and employers that resulted from the program in the reporting period; (5) Audit findings for the reporting period including, during the first three reporting periods, information on the implementation of the audit plan; and (6) Any other information as determined by the department of health." SECTION 2. This Act shall take effect upon approval. INTRODUCED BY: _____________________________
48	48
49	49	SECTION 1. The Hawaii Revised Statutes is amended by adding a new chapter to be appropriately designated and to read as follows:
50	50
51	51	"Chapter
52	52
53	53	wholesale importation of prescription drugs
54	54
55	55	§ -1 Wholesale prescription drug importation program; established. The department of health shall administer in consultation with relevant state stakeholders and federal offices and agencies, a wholesale prescription drug importation program that will meet the requirements of title 21 United States Code section 384, including requirements regarding safety and cost savings. In developing a wholesale prescription drug importation program for federal certification, the department of health shall ensure that:
56	56
57	57	(1) The department of health either becomes a licensed wholesaler or licenses an entity to become a wholesaler for the purpose of seeking federal certification and approval to import safe prescription drugs that will provide savings to consumers;
58	58
59	59	(2) The program uses Canadian suppliers who are regulated under the appropriate Canadian laws;
60	60
61	61	(3) The program implements a process to sample the purity, chemical composition, and potency of imported prescription drugs;
62	62
63	63	(4) The program only imports prescription drugs that are expected to generate substantial savings for consumers;
64	64
65	65	(5) Imported prescription drugs shall not be distributed, dispensed, or sold outside of the State;
66	66
67	67	(6) Pharmacies and health care providers shall not charge individual consumers and health plans more than the actual acquisition cost of the dispensed, imported prescription drug;
68	68
69	69	(7) Health plan payments of the prescription drug component of pharmacy and health care provider billing are not more than the health plan's share of the actual acquisition cost of the dispensed, imported prescription drug;
70	70
71	71	(8) Participating health plans update their formularies and claims payment systems with the prescription drugs that are provided through the wholesale prescription drug importation program;
72	72
73	73	(9) Participating health plans shall not base patient cost-sharing upon more than the patient's share of the actual acquisition cost of the dispensed, imported prescription drug;
74	74
75	75	(10) Participating health plans demonstrate to the satisfaction of the director of health that savings on imported prescription drugs are reflected in premiums;
76	76
77	77	(11) The profit margin of any participating wholesaler or distributor of imported prescription drugs is limited to a specified amount, to be established by the department of health;
78	78
79	79	(12) The program shall not import generic prescription drugs that would violate federal patent laws for federally-branded prescription drugs;
80	80
81	81	(13) The program complies with the requirements of title 21 United States Code sections 360eee and 360eee-1, pertaining to the track and trace requirements as enacted in Title II of the Drug Quality and Security Act (Public Law 113-54) to the extent practical and feasible before imported prescription drugs come into possession of the state wholesaler, and complies fully after imported prescription drugs are in the possession of the state wholesaler;
82	82
83	83	(14) The program is adequately financed through a fee on each prescription or other appropriate approach, but the size of the fee shall not jeopardize significant consumer savings; and
84	84
85	85	(15) The program shall be audited regularly to ensure that:
86	86
87	87	(A) The department of health determines the most cost-effective prescription drugs to include on an ongoing basis in the prescription drug importation program;
88	88
89	89	(B) The department of health selects Canadian suppliers of high quality and performance that are in full compliance with Canadian law and regulation;
90	90
91	91	(C) Imported prescription drugs under the state program are not shipped, sold, or dispensed outside the State once in the possession of the State;
92	92
93	93	(D) Imported prescription drugs are pure, unadulterated, potent, and safe;
94	94
95	95	(E) Participating pharmacies and administering providers do not charge more than the actual acquisition cost to any consumer or any participating health plan;
96	96
97	97	(F) Participating health plan formularies and claims processing systems remain updated with all relevant aspects of the prescription drug importation program;
98	98
99	99	(G) Participating health plans base patient coinsurance and other cost sharing upon the patient's share of the actual acquisition cost of covered, imported prescription drugs;
100	100
101	101	(H) Participating health plans reimburse participating pharmacies and administering providers the health plan's share of actual acquisition cost for dispensed, imported prescription drugs;
102	102
103	103	(I) The program is adequately financed to support all administrative functions while generating significant consumer savings;
104	104
105	105	(J) The program does not put consumers at higher risk than if the program did not exist; and
106	106
107	107	(K) The program continues to provide consumers in the State with substantial savings on prescription drugs.
108	108
109	109	§ -2 Monitoring for anti-competitive behavior. The department of health shall coordinate with the department of the attorney general to identify the potential for anti-competitive behavior in industries that would be affected by a program of wholesale prescription drug importation.
110	110
111	111	§ -3 Submission of request for federal certification and approval. The department of health shall submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the State's wholesale prescription drug importation program.
112	112
113	113	§ -4 Implementation and additional administrative requirements. Upon certification and approval by the Secretary of the United States Department of Health and Human Services, the department of health shall begin implementation of the wholesale prescription drug importation program and shall begin to operate the program within six months of the date of the Secretary's certification. As part of the implementation process, the department of health shall:
114	114
115	115	(1) Become licensed as a wholesaler or license an entity to become a wholesaler;
116	116
117	117	(2) Contract with a state-licensed distributor or distributors;
118	118
119	119	(3) Contract with a licensed or regulated Canadian supplier or suppliers;
120	120
121	121	(4) Engage health plans, employers, pharmacies, providers, and consumers;
122	122
123	123	(5) Develop a registration process for participating health plans, pharmacies, and administering providers;
124	124
125	125	(6) Create a publicly available list of prices of imported prescription drugs that will be available to all participating entities and consumers;
126	126
127	127	(7) Create an outreach and marketing plan to generate program awareness;
128	128
129	129	(8) Create and staff a hotline to respond to inquiries from consumers, employers, plans, pharmacies, and providers;
130	130
131	131	(9) Establish an audit process and a two-year audit work plan cycle; and
132	132
133	133	(10) Conduct any other activities necessary to the successful implementation, as determined by the department of health.
134	134
135	135	§ -5 Report to the governor and the legislature. The department of health shall provide an annual report to the governor and the legislature that includes:
136	136
137	137	(1) The prescription drugs covered in the wholesale prescription drug importation program;
138	138
139	139	(2) The number of participating pharmacies, providers, and health plans;
140	140
141	141	(3) The number of prescriptions dispensed under the program in the reporting period;
142	142
143	143	(4) The estimated savings to consumers, health plans, and employers that resulted from the program in the reporting period;
144	144
145	145	(5) Audit findings for the reporting period including, during the first three reporting periods, information on the implementation of the audit plan; and
146	146
147	147	(6) Any other information as determined by the department of health."
148	148
149	149	SECTION 2. This Act shall take effect upon approval.
150	150
151	151
152	152
153	153	INTRODUCED BY: _____________________________
154	154
155	155	INTRODUCED BY:
156	156
157	157	_____________________________
158	158
159	159
160	160
161	161
162	162
163	163	Report Title: DOH; Prescription Drugs; Importation Description: Directs the Department of Health to implement a program for wholesale importation of prescription drugs. The summary description of legislation appearing on this page is for informational purposes only and is not legislation or evidence of legislative intent.
164	164
165	165
166	166
167	167
168	168
169	169	Report Title:
170	170
171	171	DOH; Prescription Drugs; Importation
172	172
173	173
174	174
175	175	Description:
176	176
177	177	Directs the Department of Health to implement a program for wholesale importation of prescription drugs.
178	178
179	179
180	180
181	181
182	182
183	183
184	184
185	185	The summary description of legislation appearing on this page is for informational purposes only and is not legislation or evidence of legislative intent.