Connecticut 2024 Regular Session

Connecticut Senate Bill SB00008 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1
2	2
3	3		LCO 1 of 29
4	4
5	5		General Assembly Substitute Bill No. 8
6	6		February Session, 2024
7	7
8	8
9	9
10	10
11	11
12	12		AN ACT CONCERNING DRUG AFFORDABILITY.
13	13		Be it enacted by the Senate and House of Representatives in General
14	14		Assembly convened:
15	15
16	16		Section 1. (NEW) (Effective July 1, 2024) For the purposes of this 1
17	17		section and sections 2 to 9, inclusive, of this act, unless the context 2
18	18		otherwise requires: 3
19	19		(1) "Canadian supplier" means a manufacturer or wholesale drug 4
20	20		distributor that is licensed or permitted under applicable Canadian law 5
21	21		to manufacture or distribute prescription drugs; 6
22	22		(2) "Canadian prescription drug importation program" or "program" 7
23	23		means the Canadian prescription drug importation program 8
24	24		established by the executive director of the Office of Health Strategy, in 9
25	25		consultation with the Commissioners of Social Services, Consumer 10
26	26		Protection and Public Health, pursuant to section 2 of this act; 11
27	27		(3) "Drug" means an article that is (A) recognized in the official United 12
28	28		States Pharmacopoeia, official Homeopathic Pharmacopoeia of the 13
29	29		United States or official National Formulary, or any supplement thereto, 14
30	30		(B) intended for use in the diagnosis, cure, mitigation, treatment or 15
31	31		prevention of disease in humans, (C) not food and intended to affect the 16
32	32		structure or any function of the human body, and (D) not a device and 17
33	33		intended for use as a component of any article specified in 18 Substitute Bill No. 8
34	34
35	35
36	36		LCO 2 of 29
37	37
38	38		subparagraphs (A) to (C), inclusive, of this subdivision; 19
39	39		(4) "Drug Quality and Security Act" means the federal Drug Quality 20
40	40		and Security Act, 21 USC 351, et seq., as amended from time to time; 21
41	41		(5) "Food, Drug and Cosmetic Act" means the federal Food, Drug and 22
42	42		Cosmetic Act, 21 USC 301, et seq., as amended by the Drug Quality and 23
43	43		Security Act, as both may be amended from time to time; 24
44	44		(6) "Laboratory" means an environmental laboratory as defined in 25
45	45		section 19a-29a of the general statutes that is accredited as a testing 26
46	46		laboratory in accordance with International Organization for 27
47	47		Standardization (ISO) 17025 standards; 28
48	48		(7) "Laboratory testing" means a quantitative and qualitative analysis 29
49	49		of a drug consistent with the applicable provisions of the official United 30
50	50		States Pharmacopoeia; 31
51	51		(8) "Medical assistance program" means the state's Medicaid program 32
52	52		established under Title XIX of the Social Security Act, as amended from 33
53	53		time to time, and the Children's Health Insurance Program established 34
54	54		under Title XXI of the Social Security Act, as amended from time to time; 35
55	55		(9) "Participating Canadian supplier" means a Canadian supplier that 36
56	56		is exporting prescription drugs, in the manufacturer's original 37
57	57		container, to a participating wholesaler for distribution in this state 38
58	58		under the program; 39
59	59		(10) "Participating wholesaler" means a wholesaler that is (A) 40
60	60		designated by the Department of Consumer Protection to distribute 41
61	61		prescription drugs, in the manufacturer's original container, obtained 42
62	62		from a participating Canadian supplier, and (B) participating in the 43
63	63		program; 44
64	64		(11) "Track-and-trace" means the product tracing process for the 45
65	65		components of the pharmaceutical distribution supply chain as 46
66	66		described in Title II of the Drug Quality and Security Act; and 47 Substitute Bill No. 8
67	67
68	68
69	69		LCO 3 of 29
70	70
71	71		(12) "Wholesaler" means a wholesaler, as defined in section 21a-70 of 48
72	72		the general statutes, that has received a certificate of registration from 49
73	73		the Commissioner of Consumer Protection pursuant to said section. 50
74	74		Sec. 2. (NEW) (Effective July 1, 2024) (a) The executive director of the 51
75	75		Office of Health Strategy, in consultation with the Commissioners of 52
76	76		Social Services, Consumer Protection and Public Health, shall establish 53
77	77		the "Canadian prescription drug importation program". 54
78	78		Notwithstanding any provision of the general statutes, the program 55
79	79		shall provide for the importation of safe and effective prescription drugs 56
80	80		from Canada for the medical assistance program that have the highest 57
81	81		potential for cost savings in this state as determined by the executive 58
82	82		director in consultation with said commissioners. 59
83	83		(b) (1) Not later than January 1, 2025, the executive director of the 60
84	84		Office of Health Strategy shall submit a request to the federal Food and 61
85	85		Drug Administration seeking approval for the program under Section 62
86	86		804 of the federal Food, Drug and Cosmetic Act, 21 USC 384(b) to 21 63
87	87		USC 384(h), inclusive, as amended from time to time. Such request shall, 64
88	88		at a minimum: 65
89	89		(A) Describe the state's plans for operating the program; 66
90	90		(B) Demonstrate that any prescription drug that is imported and 67
91	91		distributed in this state under the program: 68
92	92		(i) Meets all applicable federal and state standards for safety and 69
93	93		effectiveness; and 70
94	94		(ii) Complies with all federal tracing procedures; and 71
95	95		(C) Disclose the costs of implementing the program. 72
96	96		(2) (A) If the federal Food and Drug Administration approves the 73
97	97		request, the executive director of the Office of Health Strategy and the 74
98	98		Commissioners of Social Services and Consumer Protection shall: 75
99	99		(i) Submit to the Commissioner of Public Health a notice disclosing 76 Substitute Bill No. 8
100	100
101	101
102	102		LCO 4 of 29
103	103
104	104		that the federal Food and Drug Administration approved such request; 77
105	105		(ii) Submit to the joint standing committees of the General Assembly 78
106	106		having cognizance of matters relating to appropriations and the budgets 79
107	107		of state agencies, general law, human services and public health a notice 80
108	108		disclosing that the federal Food and Drug Administration approved 81
109	109		such request; and 82
110	110		(iii) Begin operating the program in conjunction with the 83
111	111		Commissioners of Social Services, Consumer Protection and Public 84
112	112		Health not later than one hundred eighty days after the date of such 85
113	113		approval. 86
114	114		(B) The executive director of the Office of Health Strategy shall not 87
115	115		operate the program unless the federal Food and Drug Administration 88
116	116		approved the request. 89
117	117		Sec. 3. (NEW) (Effective July 1, 2024) Each participating wholesaler 90
118	118		may import and distribute a prescription drug in this state for use in the 91
119	119		medical assistance program from a participating Canadian supplier 92
120	120		under the program if: 93
121	121		(1) Such drug meets the United States Food and Drug 94
122	122		Administration's standards concerning drug safety, effectiveness, 95
123	123		misbranding and adulteration; 96
124	124		(2) Importing such drug would not violate federal patent laws; and 97
125	125		(3) Such drug is not: 98
126	126		(A) A controlled substance, as defined in 21 USC 802, as amended 99
127	127		from time to time; 100
128	128		(B) A biological product, as defined in 42 USC 262, as amended from 101
129	129		time to time; 102
130	130		(C) An infused drug; 103
131	131		(D) An intravenously injected drug; 104 Substitute Bill No. 8
132	132
133	133
134	134		LCO 5 of 29
135	135
136	136		(E) A drug that is inhaled during surgery; or 105
137	137		(F) A drug that is a parenteral drug, the importation of which is 106
138	138		determined by the federal Secretary of Health and Human Services to 107
139	139		pose a threat to the public health. 108
140	140		Sec. 4. (NEW) (Effective July 1, 2024) Participating wholesalers may, 109
141	141		subject to the provisions of sections 2 to 9, inclusive, of this act, import 110
142	142		and distribute drugs in this state for use in the medical assistance 111
143	143		program from a participating Canadian supplier under the program to: 112
144	144		(1) A pharmacy or institutional pharmacy, as defined in section 20-113
145	145		571 of the general statutes, solely for prescriptions covered under the 114
146	146		medical assistance program; and 115
147	147		(2) A laboratory registered with the Department of Public Health 116
148	148		under section 19a-29a of the general statutes to perform analytical 117
149	149		testing. 118
150	150		Sec. 5. (NEW) (Effective July 1, 2024) The executive director of the 119
151	151		Office of Health Strategy shall require that each participating Canadian 120
152	152		supplier and participating wholesaler (1) comply with all applicable 121
153	153		track-and-trace requirements, and shall not distribute, dispense or sell 122
154	154		outside of this state any prescription drug that is imported into this state 123
155	155		under the program, and (2) make available to the executive director all 124
156	156		track-and-trace records not later than forty-eight hours after the 125
157	157		executive director requests such records. 126
158	158		Sec. 6. (NEW) (Effective July 1, 2024) (a) The participating wholesaler 127
159	159		shall ensure the safety and quality of all drugs that are imported and 128
160	160		distributed in this state under the program. The participating 129
161	161		wholesaler shall: 130
162	162		(1) For each initial shipment of a drug that is imported into this state 131
163	163		by a participating wholesaler, ensure that a laboratory engaged by the 132
164	164		participating wholesaler tests a statistically valid sample size for each 133
165	165		batch of each drug in such shipment for authenticity and degradation in 134 Substitute Bill No. 8
166	166
167	167
168	168		LCO 6 of 29
169	169
170	170		a manner that is consistent with the Food, Drug and Cosmetic Act; 135
171	171		(2) For each shipment of a drug that is imported into this state by a 136
172	172		participating wholesaler and has been sampled and tested pursuant to 137
173	173		subdivision (1) of this subsection, ensure that a laboratory engaged by 138
174	174		the participating wholesaler tests a statistically valid sample of such 139
175	175		shipment for authenticity and degradation in a manner that is consistent 140
176	176		with the Food, Drug and Cosmetic Act; 141
177	177		(3) Certify that each drug imported into this state under the program: 142
178	178		(A) Is approved for marketing in the United States and not 143
179	179		adulterated or misbranded; and 144
180	180		(B) Meets all of the labeling requirements under 21 USC 352, as 145
181	181		amended from time to time; 146
182	182		(4) Maintain laboratory records, including, but not limited to, 147
183	183		complete data derived from all tests necessary to ensure that each drug 148
184	184		imported into this state under the program is in compliance with the 149
185	185		requirements of this section; and 150
186	186		(5) Maintain documentation demonstrating that the testing required 151
187	187		by this section was conducted at a laboratory in accordance with the 152
188	188		Food, Drug and Cosmetic Act and all other applicable federal and state 153
189	189		laws and regulations concerning laboratory qualifications. 154
190	190		(b) The participating wholesaler shall maintain all information and 155
191	191		documentation that is submitted pursuant to this section for a period of 156
192	192		not less than three years from the date of submission. 157
193	193		(c) Each participating wholesaler shall maintain all of the following 158
194	194		information for each drug that such participating wholesaler imports 159
195	195		and distributes in this state under the program, and submit such 160
196	196		information to the executive director of the Office of Health Strategy 161
197	197		upon request by the executive director: 162
198	198		(1) The name and quantity of the active ingredient of such drug; 163 Substitute Bill No. 8
199	199
200	200
201	201		LCO 7 of 29
202	202
203	203		(2) A description of the dosage form of such drug; 164
204	204		(3) The date on which such participating wholesaler received such 165
205	205		drug; 166
206	206		(4) The quantity of such drug that such participating wholesaler 167
207	207		received; 168
208	208		(5) The point of origin and destination of such drug; 169
209	209		(6) The price paid by such participating wholesaler for such drug; 170
210	210		(7) A report for any drug that fails laboratory testing; and 171
211	211		(8) Such additional information and documentation that the 172
212	212		executive director of the Office of Health Strategy deems necessary to 173
213	213		ensure the protection of the public health. 174
214	214		(d) The executive director of the Office of Health Strategy shall 175
215	215		require each participating Canadian supplier to maintain the following 176
216	216		information and documentation and, upon request by the executive 177
217	217		director, submit such information and documentation to the executive 178
218	218		director and the Commissioner of Consumer Protection for each drug 179
219	219		that such participating Canadian supplier exports into this state under 180
220	220		the program: 181
221	221		(1) The original source of such drug, including, but not limited to: 182
222	222		(A) The name of the manufacturer of such drug; 183
223	223		(B) The date on which such drug was manufactured; and 184
224	224		(C) The location where such drug was manufactured; 185
225	225		(2) The date on which such drug was shipped; 186
226	226		(3) The quantity of such drug that was shipped; 187
227	227		(4) The quantity of each lot of such drug originally received and the 188
228	228		source of such lot; 189 Substitute Bill No. 8
229	229
230	230
231	231		LCO 8 of 29
232	232
233	233		(5) The lot or control number and the batch number assigned to such 190
234	234		drug by the manufacturer; and 191
235	235		(6) Such additional information and documentation that the 192
236	236		executive director of the Office of Health Strategy, in consultation with 193
237	237		the Commissioners of Social Services, Consumer Protection and Public 194
238	238		Health, deems necessary to ensure the protection of the public health. 195
239	239		Sec. 7. (NEW) (Effective July 1, 2024) (a) The executive director of the 196
240	240		Office of Health Strategy shall issue a written order: 197
241	241		(1) Suspending importation and distribution of a drug under the 198
242	242		program if the executive director discovers that such distribution or 199
243	243		importation violates any provision of sections 2 to 9, inclusive, of this 200
244	244		act or any other applicable state or federal law or regulation; 201
245	245		(2) Suspending all importation and distribution of drugs by a 202
246	246		participating wholesaler under the program if the executive director 203
247	247		discovers that the participating wholesaler has violated any provision 204
248	248		of sections 2 to 9, inclusive, of this act or any other applicable state or 205
249	249		federal law or regulation; 206
250	250		(3) Suspending all importation and distribution of drugs by a 207
251	251		participating Canadian supplier under the program if the executive 208
252	252		director discovers that the participating Canadian supplier has violated 209
253	253		any provision of sections 2 to 9, inclusive, of this act or any other 210
254	254		applicable state or federal law or regulation; or 211
255	255		(4) Requiring the recall or seizure of any drug that was imported and 212
256	256		distributed under the program and has been identified as adulterated, 213
257	257		within the meaning of section 21a-105 of the general statutes, or 214
258	258		misbranded. 215
259	259		(b) The executive director of the Office of Health Strategy shall send 216
260	260		a notice to each participating Canadian supplier and participating 217
261	261		wholesaler affected by an order issued pursuant to subsection (a) of this 218
262	262		section notifying such participating Canadian supplier or participating 219 Substitute Bill No. 8
263	263
264	264
265	265		LCO 9 of 29
266	266
267	267		wholesaler that: 220
268	268		(1) The executive director of the Office of Health Strategy has issued 221
269	269		such order, and provide the legal and factual basis for such order; and 222
270	270		(2) Such participating Canadian supplier or participating wholesaler 223
271	271		may request, in writing, a hearing before the executive director of the 224
272	272		Office of Health Strategy, provided such request is received by the 225
273	273		executive director not later than thirty days after the date of such notice. 226
274	274		(c) If a hearing is timely requested pursuant to subsection (b) of this 227
275	275		section, the executive director of the Office of Health Strategy shall, not 228
276	276		later than thirty days after the receipt of the request, convene the hearing 229
277	277		as a contested case in accordance with the provisions of chapter 54 of 230
278	278		the general statutes. Not later than sixty days after the receipt of such 231
279	279		request, the executive director shall issue a final decision vacating, 232
280	280		modifying or affirming the order. The participating Canadian supplier 233
281	281		or participating wholesaler aggrieved by such final decision may appeal 234
282	282		such decision in accordance with the provisions of section 4-183 of the 235
283	283		general statutes. 236
284	284		Sec. 8. (NEW) (Effective July 1, 2024) The executive director of the 237
285	285		Office of Health Strategy may, in consultation with the Commissioners 238
286	286		of Social Services, Consumer Protection and Public Health, adopt 239
287	287		regulations in accordance with the provisions of chapter 54 of the 240
288	288		general statutes to implement the provisions of sections 2 to 9, inclusive, 241
289	289		of this act. 242
290	290		Sec. 9. (NEW) (Effective July 1, 2024) Not later than one hundred eighty 243
291	291		days after the program begins, and annually thereafter, the executive 244
292	292		director of the Office of Health Strategy established under section 19a-245
293	293		754a of the general statutes shall submit a report, in accordance with the 246
294	294		provisions of section 11-4a of the general statutes, to the joint standing 247
295	295		committees of the General Assembly having cognizance of matters 248
296	296		relating to appropriations and the budgets of state agencies, general law, 249
297	297		human services and public health. Such report shall describe the 250
298	298		operations of the program established pursuant to section 2 of this act 251 Substitute Bill No. 8
299	299
300	300
301	301		LCO 10 of 29
302	302
303	303		and recommendations for expanding the program to other state-funded 252
304	304		and privately funded health care programs. 253
305	305		Sec. 10. (NEW) (Effective July 1, 2024) (a) There is established the 254
306	306		Prescription Drug Affordability Board to advise the executive director 255
307	307		of the Office of Health Strategy on decisions regarding the affordability 256
308	308		of prescription drugs. The board shall be within the Office of Health 257
309	309		Strategy for administrative purposes only. 258
310	310		(b) The purposes of the Prescription Drug Affordability Board shall 259
311	311		be to (1) explore strategies to reduce out-of-pocket drug costs to 260
312	312		consumers while supporting innovations in biotechnology and scientific 261
313	313		discovery, (2) study the prescription drug supply chain and 262
314	314		pharmaceutical pricing strategies to identify opportunities for consumer 263
315	315		savings, (3) monitor prescription drug prices in the state, (4) promote 264
316	316		innovative strategies for the use of more affordable drugs, (5) take into 265
317	317		consideration recommendations of a stakeholder council established 266
318	318		pursuant to section 11 of this act, and (6) recommend a range of options 267
319	319		of prescription drug cost affordability tools to the executive director of 268
320	320		the Office of Health Strategy. 269
321	321		(c) The board shall consist of five members, each of whom shall have 270
322	322		an advanced degree and experience or expertise in health care 271
323	323		economics, health services research, pharmacoeconomics, 272
324	324		pharmacology or clinical medicine. At least one such member shall have 273
325	325		direct experience with consumer advocacy and health equity. The 274
326	326		members shall be appointed by and serve at the pleasure of the 275
327	327		Governor with the advice and consent of either house of the General 276
328	328		Assembly. The Governor shall make all initial appointments not later 277
329	329		than January 1, 2025. Any vacancy shall be filled for the remainder of 278
330	330		the unexpired term by the Governor. 279
331	331		(d) Each member of the board shall serve a term of three years, except 280
332	332		as to the terms of the members who are first appointed to the board. 281
333	333		Two such members shall serve an initial term of three years, two such 282
334	334		members shall serve an initial term of two years and one such member 283 Substitute Bill No. 8
335	335
336	336
337	337		LCO 11 of 29
338	338
339	339		shall serve an initial term of one year, to be determined by the Governor. 284
340	340		The Governor may remove any appointed member of the board for 285
341	341		malfeasance in office, failure to regularly attend meetings or any cause 286
342	342		that renders the member incapable or unfit to discharge the duties of the 287
343	343		member's office. Any such removal is not subject to review. 288
344	344		(e) The Governor shall designate one member of the board to serve as 289
345	345		the chairperson of the board. Such chairperson shall schedule the first 290
346	346		meeting of the board, which shall be held not later than February 1, 2025. 291
347	347		(f) The board shall meet not less than four times annually to carry out 292
348	348		its purposes as set forth in subsection (b) of this section. A majority of 293
349	349		the board shall constitute a quorum. The concurrence of a majority of 294
350	350		the board in any matter within its powers and duties is required for any 295
351	351		determination made by the board. Any conflict of interest involving a 296
352	352		member of the board shall be disclosed at the next board meeting after 297
353	353		the conflict is identified. 298
354	354		(g) Not later than December 31, 2025, and annually thereafter, the 299
355	355		board shall report, in accordance with the provisions of section 11-4a of 300
356	356		the general statutes, to the joint standing committees of the General 301
357	357		Assembly having cognizance of matters relating to aging, general law, 302
358	358		human services, insurance and public health. The report shall include, 303
359	359		but need not be limited to: (1) Strategies for identifying and eliminating 304
360	360		pricing or business practices that do not support or enhance innovation 305
361	361		in drug development, (2) price trends and affordability strategies for 306
362	362		any drug identified pursuant to subsection (b) or (c) of section 13 of this 307
363	363		act, (3) any recommendations the board may have for legislation needed 308
364	364		to make prescription drug products more affordable in the state while 309
365	365		supporting and enhancing innovation in drug development, (4) 310
366	366		purchasing strategies, cost effectiveness evaluations and the 311
367	367		development of new technologies and drugs that increase affordability, 312
368	368		and (5) a summary and evaluation of state prescription drug advisory 313
369	369		board activities and recommendations. 314
370	370		(h) Members of the board may engage in private employment, or in 315 Substitute Bill No. 8
371	371
372	372
373	373		LCO 12 of 29
374	374
375	375		a profession or business, subject to any applicable laws, rules and 316
376	376		regulations of the state regarding official ethics or conflict of interest. As 317
377	377		used in this subsection, (1) "conflict of interest" means (A) an association 318
378	378		of a board member, including a financial or personal association, that 319
379	379		has the potential to bias or appear to bias a board member's decisions in 320
380	380		matters related to the board, and (B) any instance in which a board 321
381	381		member, a staff member, a contractor of the division on behalf of the 322
382	382		board or an immediate family member of a board member has received 323
383	383		or could receive (i) a financial benefit of any amount derived from the 324
384	384		results or findings of a study or determination that is reached by or for 325
385	385		the board, or (ii) a financial benefit from an individual or company that 326
386	386		owns or manufacturers a prescription drug, service or item that is being 327
387	387		or will be studied by the board; and (2) "financial benefit" means 328
388	388		honoraria, fees, stock or any other form of compensation, including 329
389	389		increases to the value of existing stock holdings. 330
390	390		(i) In carrying out its purposes, the board may: 331
391	391		(1) Collect and review publicly available information and 332
392	392		information available via private subscriptions regarding prescription 333
393	393		drug pricing and business practices of health carriers, health 334
394	394		maintenance organizations, managed care organizations, 335
395	395		manufacturers, wholesale distributors and pharmacy benefit managers, 336
396	396		including, but not limited to, the annual report by pharmacy benefit 337
397	397		managers required pursuant to section 38a-479ppp of the general 338
398	398		statutes; 339
399	399		(2) Identify innovative strategies that may reduce the cost of 340
400	400		prescription drugs to consumers, including importation of certain 341
401	401		prescription drugs from Canada and other foreign countries and 342
402	402		jurisdictions; 343
403	403		(3) Identify states with innovative programs to lower prescription 344
404	404		drug costs and, if approved by the board, enter into memoranda of 345
405	405		understanding with such states to aid in the collection of transparency 346
406	406		data for prescription drug products or any other information needed to 347 Substitute Bill No. 8
407	407
408	408
409	409		LCO 13 of 29
410	410
411	411		establish similar programs in this state; and 348
412	412		(4) Receive and accept aid or contributions from any source of money, 349
413	413		property, labor or other things of value, to be held, used and applied to 350
414	414		carry out the purposes of the board, provided acceptance of such aid or 351
415	415		contributions does not present a conflict of interest for any board 352
416	416		member or any purpose of the board. 353
417	417		Sec. 11. (NEW) (Effective July 1, 2024) (a) There is established a 354
418	418		Prescription Drug Affordability Stakeholder Council to advise the 355
419	419		Prescription Drug Affordability Board established pursuant to section 356
420	420		10 of this act on decisions regarding the affordability of prescription 357
421	421		drugs. 358
422	422		(b) Members of the council shall serve for three years and shall consist 359
423	423		of: 360
424	424		(1) Three appointed by the speaker of the House of Representatives, 361
425	425		who shall be (A) a representative of a state-wide health care advocacy 362
426	426		coalition, (B) a representative of a state-wide advocacy organization for 363
427	427		elderly persons, and (C) a representative of a state-wide organization 364
428	428		for diverse communities; 365
429	429		(2) Three appointed by the president pro tempore of the Senate, who 366
430	430		shall be (A) a representative of a labor union, (B) a health services 367
431	431		researcher, and (C) a consumer who has experienced barriers to 368
432	432		obtaining prescription drugs due to the cost of such drugs; 369
433	433		(3) Two appointed by the majority leader of the House of 370
434	434		Representatives, who shall be (A) a representative of physicians, and (B) 371
435	435		a representative of nurses; 372
436	436		(4) Two appointed by the minority leader of the House of 373
437	437		Representatives, who shall be (A) a representative of private insurers, 374
438	438		and (B) a representative of brand-name drug corporations; 375
439	439		(5) Two appointed by the minority leader of the Senate, who shall be 376
440	440		(A) a representative of generic drug corporations, and (B) a 377 Substitute Bill No. 8
441	441
442	442
443	443		LCO 14 of 29
444	444
445	445		representative of an academic institution with expertise in health care 378
446	446		costs; 379
447	447		(6) Two appointed by the Governor, who shall be (A) a representative 380
448	448		of pharmacists, and (B) a representative of pharmacy benefit managers; 381
449	449		(7) The Secretary of the Office of Policy and Management, or the 382
450	450		secretary's designee; 383
451	451		(8) The Commissioner of Social Services, or the commissioner's 384
452	452		designee; 385
453	453		(9) The Commissioner of Public Health, or the commissioner's 386
454	454		designee; 387
455	455		(10) The Insurance Commissioner, or the commissioner's designee; 388
456	456		(11) The Commissioner of Consumer Protection, or the 389
457	457		commissioner's designee; 390
458	458		(12) The executive director of the Office of Health Strategy, or the 391
459	459		executive director's designee; and 392
460	460		(13) The Healthcare Advocate, or the Healthcare Advocate's 393
461	461		designee. 394
462	462		(c) All initial appointments to the council shall be made not later than 395
463	463		November 1, 2024. Any vacancy shall be filled by the appointing 396
464	464		authority. 397
465	465		(d) The speaker of the House of Representatives and the president 398
466	466		pro tempore of the Senate shall select the chairpersons of the council 399
467	467		from among the members of the council. Such chairpersons shall 400
468	468		schedule the first meeting of the council, which shall be held not later 401
469	469		than sixty days after the effective date of this section. 402
470	470		(e) The administrative staff of the joint standing committee of the 403
471	471		General Assembly having cognizance of matters relating to insurance 404
472	472		shall serve as administrative staff of the council. 405 Substitute Bill No. 8
473	473
474	474
475	475		LCO 15 of 29
476	476
477	477		(f) Not later than September 1, 2025, and annually thereafter, the 406
478	478		council shall submit a report to the board, in accordance with the 407
479	479		provisions of section 11-4a of the general statutes, on its 408
480	480		recommendations concerning prescription drug prices. The council 409
481	481		shall also provide recommendations to the board at any time the board 410
482	482		requests such recommendations. 411
483	483		Sec. 12. (NEW) (Effective July 1, 2024) As used in this section and 412
484	484		section 13 of this act: 413
485	485		(1) "Biologic" means a drug licensed under 42 USC 262, as amended 414
486	486		from time to time; 415
487	487		(2) "Biosimilar" means a drug that is highly similar to a biologic and 416
488	488		is produced or distributed in accordance with a biologics license 417
489	489		application approved under 42 USC 262(k), as amended from time to 418
490	490		time; 419
491	491		(3) "Board" means the Prescription Drug Affordability Board 420
492	492		established pursuant to section 10 of this act; 421
493	493		(4) "Brand-name drug" means a drug that is produced or distributed 422
494	494		in accordance with an original new drug application approved under 21 423
495	495		USC 355, as amended from time to time, but does not include an 424
496	496		authorized generic drug as defined in 42 CFR 447.502, as amended from 425
497	497		time to time; 426
498	498		(5) "FDA breakthrough drug" means a drug granted expedited 427
499	499		review by the United States Food and Drug Administration under 21 428
500	500		USC 356, as amended from time to time; 429
501	501		(6) "Generic drug" means (A) a prescription drug product that is 430
502	502		marketed or distributed in accordance with an abbreviated new drug 431
503	503		application approved under 21 USC 355, as amended from time to time, 432
504	504		(B) an authorized generic drug as defined in 42 CFR 447.502, as 433
505	505		amended from time to time, or (C) a drug that entered the market before 434
506	506		calendar year 1962 that was not originally marketed under a new 435 Substitute Bill No. 8
507	507
508	508
509	509		LCO 16 of 29
510	510
511	511		prescription drug product application; 436
512	512		(7) "Manufacturer" means an entity that (A) engages in the 437
513	513		manufacture of a drug product, or (B) enters into a lease with another 438
514	514		manufacturer to market and distribute a prescription drug product 439
515	515		under the entity's own name and sets or changes the wholesale 440
516	516		acquisition cost of the prescription drug product it manufactures or 441
517	517		markets; 442
518	518		(8) "Orphan drug" has the same meaning as provided in 21 CFR 316.3, 443
519	519		as amended from time to time; and 444
520	520		(9) "Prescription drug product" means a brand-name drug, a generic 445
521	521		drug, a biologic or biosimilar. 446
522	522		Sec. 13. (NEW) (Effective July 1, 2024) (a) To the extent practicable, the 447
523	523		Prescription Drug Affordability Board established pursuant to section 448
524	524		10 of this act may assess pricing information for prescription drug 449
525	525		products by: (1) Entering into a memorandum of understanding with 450
526	526		another state to which a manufacturer reports pricing information, (2) 451
527	527		assessing spending for the drug in the state, (3) utilizing data and 452
528	528		findings, including consumer affordability strategies, developed by 453
529	529		another state's board, (4) utilizing data and findings, including cost 454
530	530		containment strategies, developed by any other state or federal entity, 455
531	531		(5) utilizing the maximum fair price for a prescription drug for persons 456
532	532		eligible for Medicare established pursuant to the federal Inflation 457
533	533		Reduction Act of 2022, P.L. No. 117-169, as amended from time to time, 458
534	534		and (6) assessing any other available pricing information. 459
535	535		(b) On and after July 1, 2025, the board shall identify prescription 460
536	536		drug products that, as adjusted annually for inflation in accordance with 461
537	537		the consumer price index for all urban consumers published by the 462
538	538		United States Department of Labor, Bureau of Labor Statistics, are: 463
539	539		(1) Brand-name drugs that have a launch wholesale acquisition cost 464
540	540		of thirty thousand dollars or more per year or course of treatment; 465 Substitute Bill No. 8
541	541
542	542
543	543		LCO 17 of 29
544	544
545	545		(2) Brand-name drugs that have a wholesale acquisition cost increase 466
546	546		of three thousand dollars or more in any twelve–month period; 467
547	547		(3) Biosimilars that have a launch wholesale acquisition cost that is 468
548	548		not at least fifteen per cent lower than the referenced brand biologic at 469
549	549		the time the biosimilars are launched; and 470
550	550		(4) Generic drugs that have: 471
551	551		(A) A wholesale acquisition cost of one hundred dollars or more for 472
552	552		(i) a thirty-day supply lasting a patient for a period of thirty consecutive 473
553	553		days based on the recommended dosage approved for labeling by the 474
554	554		United States Food and Drug Administration, (ii) a supply lasting a 475
555	555		patient for fewer than thirty days based on the recommended dosage 476
556	556		approved for labeling by the United States Food and Drug 477
557	557		Administration, or (iii) one unit of the drug if the labeling approved by 478
558	558		the United States Food and Drug Administration does not recommend 479
559	559		a finite dosage; and 480
560	560		(B) A wholesale acquisition cost that increased by two hundred per 481
561	561		cent or more during the immediately preceding twelve-month period, 482
562	562		as determined by the difference between the resulting wholesale 483
563	563		acquisition cost and the average of the wholesale acquisition cost 484
564	564		reported over the immediately preceding twelve months. 485
565	565		(c) On and after July 1, 2025, the board shall identify any other 486
566	566		prescription drug products or pricing practices that may create 487
567	567		affordability challenges for the health care system in the state or 488
568	568		patients, including, but not limited to, drugs needed to address 489
569	569		significant public health priorities. 490
570	570		(d) After identifying prescription drug products as required by 491
571	571		subsections (b) and (c) of this section, the board may conduct, within 492
572	572		available appropriations, a review for any identified prescription drug 493
573	573		product or pricing practice if, after (1) seeking input from relevant 494
574	574		stakeholders, and (2) considering the average patient cost share of the 495
575	575		prescription drug product, the board determines such review is in the 496 Substitute Bill No. 8
576	576
577	577
578	578		LCO 18 of 29
579	579
580	580		interest of consumers. 497
581	581		(e) In conducting a review of prescription drugs, the board shall 498
582	582		examine any document and research related to the pricing of the 499
583	583		prescription drug product, including, but not limited to, (1) net average 500
584	584		price in the state, (2) market competition and context, (3) projected 501
585	585		revenue to the manufacturer, (4) the estimated value or cost 502
586	586		effectiveness, (5) whether and how the prescription drug product 503
587	587		represents an innovative therapy or is likely to improve health or health 504
588	588		outcomes for the target consumer, and (6) any rebates, discounts, patient 505
589	589		access programs or other cost mitigation strategies relevant to the 506
590	590		prescription drug product. As part of its review, the board may also 507
591	591		examine the costs or potential costs of FDA breakthrough and orphan 508
592	592		drugs. 509
593	593		(f) The board shall determine whether use of the prescription drug 510
594	594		product, consistent with the labeling approved by the federal Food and 511
595	595		Drug Administration or standard medical practice, has led or will lead 512
596	596		to affordability challenges for the health care system in the state or high 513
597	597		out-of-pocket costs for patients. In determining whether a prescription 514
598	598		drug product has led or will lead to an affordability challenge, the board 515
599	599		may consider the following factors: 516
600	600		(1) The wholesale acquisition cost for the prescription drug product 517
601	601		sold in the state; 518
602	602		(2) The average monetary price concession, discount or rebate 519
603	603		provided or expected to be provided to health plans in the state as 520
604	604		reported by manufacturers and health plans, expressed as a percentage 521
605	605		of the wholesale acquisition cost for the prescription drug product 522
606	606		under review; 523
607	607		(3) The total amount of the price concession, discount or rebate the 524
608	608		manufacturer provides to each pharmacy benefits manager operating in 525
609	609		the state for the prescription drug product under review, as reported by 526
610	610		manufacturers and pharmacy benefits managers, expressed as a 527
611	611		percentage of the wholesale acquisition costs; 528 Substitute Bill No. 8
612	612
613	613
614	614		LCO 19 of 29
615	615
616	616		(4) The price at which therapeutic alternatives have been sold in the 529
617	617		state; 530
618	618		(5) The average monetary concession, discount or rebate the 531
619	619		manufacturer provides or is expected to provide to health plan payors 532
620	620		and pharmacy benefits managers in the state for therapeutic 533
621	621		alternatives; 534
622	622		(6) The costs to health plans based on patient access consistent with 535
623	623		United States Food and Drug Administration labeled indications and 536
624	624		recognized standard medical practice; 537
625	625		(7) The impact on patient access resulting from the cost of the 538
626	626		prescription drug product relative to health plan benefit design; 539
627	627		(8) The current or expected dollar value of drug–specific patient 540
628	628		access programs that are supported by the manufacturer; 541
629	629		(9) The relative financial impacts to health, medical or social services 542
630	630		costs as may be quantified and compared to baseline effects of existing 543
631	631		therapeutic alternatives; 544
632	632		(10) The average patient copayment or other cost sharing for the 545
633	633		prescription drug product in the state; 546
634	634		(11) Any information a manufacturer chooses to provide; and 547
635	635		(12) Any other factors as determined by the board. 548
636	636		(g) If the board finds that the spending on a prescription drug 549
637	637		product reviewed under this section has led or will lead to an 550
638	638		affordability challenge, the board shall recommend an upper payment 551
639	639		limit to the executive director of the Office of Health Strategy and the 552
640	640		Insurance Commissioner after considering: (1) The cost of administering 553
641	641		the drug, (2) the cost of delivering the drug to patients, and (3) other 554
642	642		relevant administrative costs related to the drug. In its 555
643	643		recommendations, the board may utilize (A) upper payment limits set 556
644	644		by similar boards in other states, provided the board finds that the other 557 Substitute Bill No. 8
645	645
646	646
647	647		LCO 20 of 29
648	648
649	649		entity's price justification process is at least as rigorous as the process set 558
650	650		forth in state law, (B) upper payment limits set by any other state or 559
651	651		federal entity, provided the board finds that the other entity's price 560
652	652		justification process is at least as rigorous as the process set forth in state 561
653	653		law, and (C) the Medicare maximum fair price for a prescription drug. 562
654	654		Sec. 14. (NEW) (Effective July 1, 2025) (a) As used in this section and 563
655	655		section 15 of this act, (1) "ERISA plan" means an employee welfare 564
656	656		benefit plan subject to the Employee Retirement Income Security Act of 565
657	657		1974, as amended from time to time; (2) "health benefit plan" has the 566
658	658		same meaning as provided in section 38a-472f of the general statutes; (3) 567
659	659		"state entity" means any state agency, or any individual employed by or 568
660	660		acting on the state's behalf that purchases a prescription drug for an 569
661	661		individual with health insurance paid for by the state, including health 570
662	662		insurance offered by local, state, or federal agencies or through 571
663	663		organizations licensed in the state; and (4) "participating ERISA plan" 572
664	664		means an ERISA plan that elects to participate in the requirements of 573
665	665		this section. 574
666	666		(b) It shall be a violation of this section for a state entity or health 575
667	667		benefit plan or participating ERISA plan to purchase drugs with an 576
668	668		established upper payment limit to be dispensed or delivered to a 577
669	669		consumer in the state, whether directly or through a distributor, for a 578
670	670		cost higher than the upper payment limit as determined in subsection 579
671	671		(g) of section 13 of this act. Contracts entered into by a state entity, health 580
672	672		benefit plan or participating ERISA plan and a third party for the 581
673	673		purchase of prescription drugs shall expressly provide that rates paid 582
674	674		for drugs may not exceed the upper payment limit. 583
675	675		(c) It shall be a violation of this section for a retail pharmacy licensed 584
676	676		in this state to purchase for sale or distribution to a person whose health 585
677	677		care is provided by a state entity or health benefit plan or participating 586
678	678		ERISA plan a drug for a cost that exceeds the upper payment limit as 587
679	679		determined in subsection (g) of section 13 of this act. 588
680	680		Sec. 15. (NEW) (Effective July 1, 2025) Any savings generated by a state 589 Substitute Bill No. 8
681	681
682	682
683	683		LCO 21 of 29
684	684
685	685		entity, health benefit plan, or participating ERISA plan that are 590
686	686		attributable to the implementation of an upper payment limit 591
687	687		established by the Prescription Drug Affordability Board shall be used 592
688	688		to reduce health care costs to consumers, prioritizing the reduction of 593
689	689		out-of-pocket costs for prescription drugs. Not later than April 1, 2026, 594
690	690		and annually thereafter, each state entity, health benefit plan and 595
691	691		participating ERISA plan shall submit to the board and to the executive 596
692	692		director of the Office of Health Strategy a report describing the savings 597
693	693		achieved as a result of implementing upper payment limits and how 598
694	694		those savings were used to reduce health care costs to consumers. Not 599
695	695		later than July 1, 2026, and annually thereafter, the executive director, in 600
696	696		accordance with the provisions of section 11-4a of the general statutes, 601
697	697		shall file a report with the joint standing committees of the General 602
698	698		Assembly having cognizance of matters relating to appropriations and 603
699	699		the budgets of state agencies, general law, human services, insurance 604
700	700		and public health. The report shall include savings achieved and the 605
701	701		executive director's recommendations concerning additional savings 606
702	702		that may be achieved. 607
703	703		Sec. 16. (NEW) (Effective July 1, 2025) (a) As used in this section, 608
704	704		"manufacturer" means an entity that (1) engages in the manufacture of 609
705	705		a drug product, or (2) enters into a lease with another manufacturer to 610
706	706		market and distribute a prescription drug product under the entity's 611
707	707		own name and sets or changes the wholesale acquisition cost of the 612
708	708		prescription drug product it manufactures or markets. Any 613
709	709		manufacturer that intends to withdraw from sale or distribution within 614
710	710		the state a prescription drug for which the Prescription Drug 615
711	711		Affordability Board has established an upper payment limit shall 616
712	712		provide a notice of withdrawal in writing at least six months before the 617
713	713		date of the intended withdrawal of such prescription drug to the board, 618
714	714		the Insurance Commissioner, the Attorney General and any entity in the 619
715	715		state with which the manufacturer has a contract for the sale or 620
716	716		distribution of the drug. 621
717	717		(b) The board shall assess a penalty not to exceed five hundred 622
718	718		thousand dollars if the board determines that a manufacturer failed to 623 Substitute Bill No. 8
719	719
720	720
721	721		LCO 22 of 29
722	722
723	723		provide the notice required by subsection (a) of this section before 624
724	724		withdrawing from sale or distribution within the state a prescription 625
725	725		drug for which the board has established an upper payment limit as 626
726	726		determined in subsection (g) of section 13 of this act. 627
727	727		(c) A representative of a manufacturer that reasonably foresees an 628
728	728		impending shortage of a prescription drug it sells or distributes in the 629
729	729		state shall notify the board not later than thirty days after determining 630
730	730		that a shortage of a prescription drug is imminent. 631
731	731		Sec. 17. (NEW) (Effective January 1, 2025) (a) As used in this section: 632
732	732		(1) "Health benefit plan" has the same meaning as provided in section 633
733	733		38a-472f of the general statutes; 634
734	734		(2) "Insulin" means an insulin product, including, but not limited to, 635
735	735		an insulin pen or vial, that is licensed under 42 USC 262(a) or 42 USC 636
736	736		262(k), as amended from time to time; 637
737	737		(3) "Eligible insulin" means an insulin product for which at least two 638
738	738		licenses have been issued and continues to be marketed pursuant to 639
739	739		such licensure; 640
740	740		(4) "Net cost" means the cost of an insulin product taking into account 641
741	741		rebates or discounts for that specific product, excluding (A) rebates or 642
742	742		discounts required by state or federal law, including Medicaid, 643
743	743		Medicare and section 340B of the Public Health Service Act, 42 USC 644
744	744		256b, as amended from time to time, and (B) rebates or discounts related 645
745	745		to portfolio agreements that relate to purchase of multiple insulin 646
746	746		products or other drugs; 647
747	747		(5) "State entity" means any state agency, or any individual employed 648
748	748		by or acting on behalf of the state, that purchases a prescription drug for 649
749	749		an individual with health insurance paid for by the state, including 650
750	750		health insurance offered by local, state, or federal agencies or through 651
751	751		organizations licensed in the state; and 652
752	752		(6) "Wholesale acquisition cost" means the price of a medication set 653 Substitute Bill No. 8
753	753
754	754
755	755		LCO 23 of 29
756	756
757	757		by a pharmaceutical manufacturer in the United States when selling to 654
758	758		a wholesaler. 655
759	759		(b) A state entity and health benefit plan shall, except as otherwise 656
760	760		required in any collective bargaining agreement affecting the state 657
761	761		employee health plan established pursuant to section 5-259 of the 658
762	762		general statutes, make available in a preferred tier with no copayment 659
763	763		or out-of-pocket cost an eligible insulin product at the lowest wholesale 660
764	764		acquisition cost to a beneficiary. Notwithstanding the provisions of this 661
765	765		section, if a state entity or health plan determines that another eligible 662
766	766		insulin product has a lower net cost than the lowest wholesale 663
767	767		acquisition cost, such entity or health plan may offer that product with 664
768	768		no out-of-pocket payment to a beneficiary of such state entity or health 665
769	769		benefit plan. Nothing in this section shall prevent such entity or health 666
770	770		benefit plan from covering more than one eligible insulin product in a 667
771	771		preferred tier with no copayment or out-of-pocket cost to a beneficiary 668
772	772		of such entity or health benefit plan. 669
773	773		Sec. 18. Section 38a-492d of the general statutes is amended by adding 670
774	774		subsection (e) as follows (Effective January 1, 2025): 671
775	775		(NEW) (e) Notwithstanding the provisions of subsection (c) of this 672
776	776		section, on and after January 1, 2025, any policy described in subsection 673
777	777		(b) of this section shall make available in a preferred tier with no 674
778	778		copayment or out-of-pocket cost an eligible insulin product at the lowest 675
779	779		wholesale acquisition cost in accordance with section 17 of this act. 676
780	780		Sec. 19. Section 38a-518d of the general statutes is amended by adding 677
781	781		subsection (e) as follows (Effective January 1, 2025): 678
782	782		(NEW) (e) Notwithstanding the provisions of subsection (c) of this 679
783	783		section, on and after January 1, 2025, any policy described in subsection 680
784	784		(b) of this section shall make available in a preferred tier with no 681
785	785		copayment or out-of-pocket cost an eligible insulin product at the lowest 682
786	786		wholesale acquisition cost in accordance with section 17 of this act. 683
787	787		Sec. 20. (NEW) (Effective July 1, 2024) (a) As used in this section: 684 Substitute Bill No. 8
788	788
789	789
790	790		LCO 24 of 29
791	791
792	792		(1) "Eligible drug" means an injectable drug product approved under 685
793	793		Section 505(j) or 505(b)(2) of the federal Food, Drug and Cosmetic Act, 686
794	794		as amended from time to time, that is on the drug shortage list, or has 687
795	795		been on such list during the prior five-year period, established under 688
796	796		Section 506E of the federal Food, Drug and Cosmetic Act, 21 USC 356e, 689
797	797		as amended from time to time, or which has otherwise been identified 690
798	798		as being at risk of shortage; 691
799	799		(2) "Drug purchasing agency" means the Departments of Correction, 692
800	800		Social Services and Mental Health and Addiction Services; 693
801	801		(3) "Long-term purchase contract" means an agreement of at least two 694
802	802		years' duration that defines price and volume commitments; and 695
803	803		(4) "Hospital" means a hospital licensed pursuant to chapter 368v of 696
804	804		the general statutes. 697
805	805		(b) Any hospital or drug purchasing agency shall have a drug 698
806	806		shortage prevention strategy covering at least forty eligible drugs, 699
807	807		corresponding to at least one-third of the hospital's or agency's expected 700
808	808		utilization of each eligible drug. The hospital or agency shall ensure that 701
809	809		any long-term purchase contract for prescription drugs requires the 702
810	810		entity contracting with the hospital or agency to: 703
811	811		(1) Hold physical reserve inventory in order to buffer supply 704
812	812		disruption or demand surge equal to two quarters of contract volume, 705
813	813		unless the drug is in shortage or otherwise subject to a supply 706
814	814		disruption; 707
815	815		(2) Have a competent quality control unit and have in place processes 708
816	816		to evaluate supplier quality; 709
817	817		(3) Have a process to ensure that critical quality attributes have been 710
818	818		met and documentation of good manufacturing practices is complete; 711
819	819		and 712
820	820		(4) Participate, in accordance with federal law, in the program 713
821	821		administered under Section 340B of the Public Health Service Act, 42 714 Substitute Bill No. 8
822	822
823	823
824	824		LCO 25 of 29
825	825
826	826		USC 256b, as amended from time to time. 715
827	827		(c) Not later than January 1, 2025, and annually thereafter, a hospital 716
828	828		shall file a report with the Commissioner of Public Health documenting 717
829	829		compliance with the provisions of this section. Not later than February 718
830	830		1, 2025, and annually thereafter, the Commissioners of Correction, 719
831	831		Mental Health and Addiction Services, Social Services and Public 720
832	832		Health shall each file separate reports on compliance of hospitals, drug 721
833	833		purchasing agencies and their contractors, as applicable, with the 722
834	834		executive director of the Office of Health Strategy. 723
835	835		(d) The executive director of the Office of Health Strategy shall, not 724
836	836		later than April 1, 2025, and annually thereafter, file a comprehensive 725
837	837		report, in accordance with the provisions of section 11-4a of the general 726
838	838		statutes, on compliance of hospitals, drug purchasing agencies and their 727
839	839		contractors with the provisions of this section with the joint standing 728
840	840		committees of the General Assembly having cognizance of matters 729
841	841		relating to the judiciary, general law, human services and public health. 730
842	842		Sec. 21. (NEW) (Effective from passage) As used in this section and 731
843	843		section 22 of this act: 732
844	844		(1) "340B drug" means a drug that (A) is a covered outpatient drug 733
845	845		within the meaning of 42 USC 256b; (B) has been subject to any offer for 734
846	846		reduced prices by a manufacturer under 42 USC 256b(a)(1); and (C) is 735
847	847		purchased by a covered entity. "340B drug" includes a drug that would 736
848	848		have been purchased but for the restriction or limitation described in 737
849	849		subsection (a) of section 22 of this act; 738
850	850		(2) "Biologic" has the same meaning as provided in section 21a-70d of 739
851	851		the general statutes; 740
852	852		(3) "Covered entity" has the same meaning as provided in Section 741
853	853		340B of the Public Health Service Act, 42 USC 256b, as amended from 742
854	854		time to time; 743
855	855		(4) "Manufacturer" has the same meaning as provided in section 21a-744 Substitute Bill No. 8
856	856
857	857
858	858		LCO 26 of 29
859	859
860	860		70 of the general statutes, except that such definition shall include 745
861	861		manufacturers of biologics; 746
862	862		(5) "Package" has the same meaning as provided in 21 USC 747
863	863		360eee(11)(A); 748
864	864		(6) "Pharmacy" has the same meaning as provided in section 20-571 749
865	865		of the general statutes; 750
866	866		(7) "Third-party logistics provider" has the same meaning as 751
867	867		provided in section 20-571 of the general statutes; and 752
868	868		(8) "Wholesaler" or "distributor" has the same meaning as provided 753
869	869		in section 21a-70 of the general statutes. 754
870	870		Sec. 22. (NEW) (Effective from passage) (a) A manufacturer, third-party 755
871	871		logistics provider, wholesaler or distributor, or an agent or affiliate of 756
872	872		such manufacturer, third-party logistics provider, wholesaler or 757
873	873		distributor, shall not, either directly or indirectly: 758
874	874		(1) Deny, restrict, prohibit, discriminate against or otherwise limit the 759
875	875		acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy 760
876	876		that is under contract with, or otherwise authorized by, a covered entity 761
877	877		to receive 340B drugs on behalf of the covered entity unless such receipt 762
878	878		is prohibited by the United States Department of Health and Human 763
879	879		Services; or 764
880	880		(2) Require a covered entity, or a pharmacy that is under contract 765
881	881		with a covered entity, to submit any claims or utilization data as a 766
882	882		condition for allowing the acquisition of a 340B drug by, or delivery of 767
883	883		a 340B drug to, a covered entity, or a pharmacy that is under contract 768
884	884		with a covered entity, unless the claims or utilization data sharing is 769
885	885		required by the United States Department of Health and Human 770
886	886		Services. 771
887	887		(b) (1) On and after July 1, 2024, if the executive director of the Office 772
888	888		of Health Strategy receives information and has a reasonable belief, after 773
889	889		evaluating such information, that any manufacturer, third-party 774 Substitute Bill No. 8
890	890
891	891
892	892		LCO 27 of 29
893	893
894	894		logistics provider, wholesaler or distributor, or an agent or affiliate of 775
895	895		such manufacturer, third-party logistics provider, wholesaler or 776
896	896		distributor, has acted in violation of any provision of this section, or rule 777
897	897		or regulation adopted thereunder, such manufacturer, third-party 778
898	898		logistics provider, wholesaler or distributor, or an agent or affiliate of 779
899	899		such manufacturer, third-party logistics provider, wholesaler or 780
900	900		distributor, shall be subject to a civil penalty of up to fifty thousand 781
901	901		dollars. The executive director may issue a notice of violation and civil 782
902	902		penalty by first-class mail or personal service. Such notice shall include: 783
903	903		(A) A reference to the section of the general statutes, rule or section of 784
904	904		the regulations of Connecticut state agencies believed or alleged to have 785
905	905		been violated; (B) a short and plain language statement of the matters 786
906	906		asserted or charged; (C) a description of the activity to cease; (D) a 787
907	907		statement of the amount of the civil penalty or penalties that may be 788
908	908		imposed; (E) a statement concerning the right to a hearing; and (F) a 789
909	909		statement that such manufacturer, third-party logistics provider, 790
910	910		wholesaler or distributor, or an agent or affiliate of such manufacturer, 791
911	911		third-party logistics provider, wholesaler or distributor, may, not later 792
912	912		than ten business days after receipt of such notice, make a request for a 793
913	913		hearing on the matters asserted. 794
914	914		(2) The manufacturer, third-party logistics provider, wholesaler or 795
915	915		distributor, or an agent or affiliate of such manufacturer, third-party 796
916	916		logistics provider, wholesaler or distributor, to whom such notice is 797
917	917		provided pursuant to subparagraph (A) of subdivision (1) of this 798
918	918		subsection may, not later than ten business days after receipt of such 799
919	919		notice, make written application to the Office of Health Strategy to 800
920	920		request a hearing to demonstrate that such violation did not occur. The 801
921	921		failure to make a timely request for a hearing shall result in the issuance 802
922	922		of a cease and desist order or imposition of a civil penalty by the office. 803
923	923		All hearings held under this subsection shall be conducted in 804
924	924		accordance with the provisions of chapter 54 of the general statutes. 805
925	925		(3) Following any hearing before the Office of Health Strategy 806
926	926		pursuant to subdivision (2) of this subsection, if the office finds, by a 807
927	927		preponderance of the evidence, that any manufacturer, third-party 808 Substitute Bill No. 8
928	928
929	929
930	930		LCO 28 of 29
931	931
932	932		logistics provider, wholesaler or distributor, or an agent or affiliate of 809
933	933		such manufacturer, third-party logistics provider, wholesaler or 810
934	934		distributor, violated or is violating any provision of this subsection, any 811
935	935		rule or regulation adopted thereunder or any order issued by the office, 812
936	936		the office shall issue a final cease and desist order in addition to any civil 813
937	937		penalty the office imposes. 814
938	938		(c) Nothing in this section shall be construed or applied to be in 815
939	939		conflict with or less restrictive than: 816
940	940		(1) Applicable federal law and related regulations, including 21 USC 817
941	941		355-1, as amended from time to time; or 818
942	942		(2) Other laws of this state to the extent such laws are compatible with 819
943	943		applicable federal law. 820
944	944		This act shall take effect as follows and shall amend the following
945	945		sections:
946	946
947	947		Section 1 July 1, 2024 New section
948	948		Sec. 2 July 1, 2024 New section
949	949		Sec. 3 July 1, 2024 New section
950	950		Sec. 4 July 1, 2024 New section
951	951		Sec. 5 July 1, 2024 New section
952	952		Sec. 6 July 1, 2024 New section
953	953		Sec. 7 July 1, 2024 New section
954	954		Sec. 8 July 1, 2024 New section
955	955		Sec. 9 July 1, 2024 New section
956	956		Sec. 10 July 1, 2024 New section
957	957		Sec. 11 July 1, 2024 New section
958	958		Sec. 12 July 1, 2024 New section
959	959		Sec. 13 July 1, 2024 New section
960	960		Sec. 14 July 1, 2025 New section
961	961		Sec. 15 July 1, 2025 New section
962	962		Sec. 16 July 1, 2025 New section
963	963		Sec. 17 January 1, 2025 New section
964	964		Sec. 18 January 1, 2025 38a-492d(e)
965	965		Sec. 19 January 1, 2025 38a-518d(e)
966	966		Sec. 20 July 1, 2024 New section Substitute Bill No. 8
967	967
968	968
969	969		LCO 29 of 29
970	970
971	971		Sec. 21 from passage New section
972	972		Sec. 22 from passage New section
973	973
974	974		HS Joint Favorable Subst.
975		-	JUD Joint Favorable
976	975