Connecticut 2020 Regular Session

Connecticut House Bill HB05366 Compare Versions

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

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3	3	LCO No. 2027 1 of 15
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5	5	General Assembly Raised Bill No. 5366
6	6	February Session, 2020
7	7	LCO No. 2027
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10	10	Referred to Committee on INSURANCE AND REAL ESTATE
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12	12
13	13	Introduced by:
14	14	(INS)
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19	19	AN ACT CONCERNING TH E COST OF PRESCRIPTION DRUGS.
20	20	Be it enacted by the Senate and House of Representatives in General
21	21	Assembly convened:
22	22
23	23	Section 1. (NEW) (Effective January 1, 2021) No insurer, health care 1
24	24	center, hospital service corporation, medical service corporation, 2
25	25	fraternal benefit society or other entity that delivers, issues for delivery, 3
26	26	renews, amends or continues an individual or group health insurance 4
27	27	policy in this state on or after January 1, 2021, that provides coverage of 5
28	28	the type specified in subdivisions (1), (2), (4), (11), (12) and (16) of section 6
29	29	38a-469 of the general statutes and includes coverage for prescription 7
30	30	drugs shall impose coinsurance, copayments, deductibles and out-of-8
31	31	pocket expenses for covered prescription drugs that, in the aggregate, 9
32	32	exceed two hundred fifty dollars per insured per month. 10
33	33	Sec. 2. (NEW) (Effective January 1, 2021) For each year beginning on or 11
34	34	after January 1, 2021, the wholesale cost of an outpatient prescription 12
35	35	drug sold in this state shall not exceed one hundred two per cent of the 13
36	36	consumer price index for all urban consumers as published by the 14
37	37	United States Department of Labor, Bureau of Labor Statistics, for the 15
38	38	preceding year. 16 Raised Bill No. 5366
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44	44	Sec. 3. (NEW) (Effective July 1, 2020) For the purposes of this section 17
45	45	and sections 4 to 8, inclusive, of this act unless the context otherwise 18
46	46	requires: 19
47	47	(1) "Drug" means an article that is (A) recognized in the official United 20
48	48	States Pharmacopoeia, official Homeopathic Pharmacopoeia of the 21
49	49	United States or official National Formulary, or any supplement thereto, 22
50	50	(B) intended for use in the diagnosis, cure, mitigation, treatment or 23
51	51	prevention of disease in humans, (C) not food and intended to affect the 24
52	52	structure or any function of the human body, and (D) not a device and 25
53	53	intended for use as a component of any other article specified in 26
54	54	subparagraphs (A) to (C), inclusive, of this subdivision; 27
55	55	(2) "Drug Quality and Security Act" means the federal Drug Quality 28
56	56	and Security Act, 21 USC 351, et seq., as amended from time to time; 29
57	57	(3) "Food, Drug and Cosmetic Act" means the Federal Food, Drug and 30
58	58	Cosmetic Act, 21 USC 301, et seq., as amended by the Drug Quality and 31
59	59	Security Act, as both may be amended from time to time; 32
60	60	(4) "Laboratory testing" means a quantitative and qualitative analysis 33
61	61	of a prescription drug consistent with the official United States 34
62	62	Pharmacopoeia; 35
63	63	(5) "Legend drug" means a drug that (A) any applicable federal or 36
64	64	state law requires to be (i) dispensed pursuant to a prescription, or (ii) 37
65	65	used by a prescribing practitioner, or (B) applicable federal law requires 38
66	66	to bear the following legend: "RX ONLY" IN ACCORDANCE WITH 39
67	67	GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND 40
68	68	COSMETIC ACT; 41
69	69	(6) "Participating Canadian supplier" means a manufacturer or 42
70	70	wholesale drug distributor that is (A) licensed or permitted under 43
71	71	applicable Canadian law to manufacture or distribute prescription 44
72	72	drugs, (B) exporting legend drugs, in the manufacturer's original 45
73	73	container, to a participating wholesaler for distribution in this state 46
74	74	under the program, and (C) properly registered, if such Canadian 47 Raised Bill No. 5366
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76	76
77	77
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80	80	supplier is required to be registered, with the United States Food and 48
81	81	Drug Administration, or any successor agency; 49
82	82	(7) "Participating wholesaler" means a wholesaler, as defined in 50
83	83	section 21a-70 of the general statutes, that (A) has received a certificate 51
84	84	of registration from the Commissioner of Consumer Protection 52
85	85	pursuant to said section, and (B) is designated by the commissioner to 53
86	86	participate in the program; 54
87	87	(8) "Prescription" means a lawful verbal, written or electronic order 55
88	88	by a prescribing practitioner for a drug for a specific patient; 56
89	89	(9) "Program" means the Canadian legend drug importation program 57
90	90	established by the Commissioner of Consumer Protection pursuant to 58
91	91	section 4 of this act; 59
92	92	(10) "Qualified laboratory" means a laboratory that is (A) adequately 60
93	93	equipped and staffed to properly perform laboratory testing on legend 61
94	94	drugs, and (B) accredited to International Organization for 62
95	95	Standardization (ISO) 17025; and 63
96	96	(11) "Track-and-trace" means the product tracing process for the 64
97	97	components of the pharmaceutical distribution supply chain, as 65
98	98	described in Title II of the Drug Quality and Security Act. 66
99	99	Sec. 4. (NEW) (Effective July 1, 2020) (a) The Commissioner of 67
100	100	Consumer Protection shall establish a program to be known as the 68
101	101	"Canadian legend drug importation program". Under such program, 69
102	102	the commissioner shall, notwithstanding any contrary provision of the 70
103	103	general statutes: 71
104	104	(1) Provide for the importation of safe and effective legend drugs 72
105	105	from Canada that have the highest potential for cost savings in this state; 73
106	106	and 74
107	107	(2) Designate one or more participating wholesalers to distribute 75
108	108	legend drugs in this state: 76 Raised Bill No. 5366
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114	114	(A) In the manufacturer's original container; 77
115	115	(B) From a participating Canadian supplier; and 78
116	116	(C) To a pharmacy or institutional pharmacy, as both terms are 79
117	117	defined in section 20-571 of the general statutes, or a qualified 80
118	118	laboratory. 81
119	119	(b) (1) Not later than July 1, 2021, the Commissioner of Consumer 82
120	120	Protection shall submit a request to the federal Secretary of Health and 83
121	121	Human Services seeking approval for the program under 21 USC 384, 84
122	122	as amended from time to time. Such request shall, at a minimum: 85
123	123	(A) Describe the commissioner's plans for operating the program; 86
124	124	(B) Demonstrate that the legend drugs that will be imported and 87
125	125	distributed in this state under the program shall: 88
126	126	(i) Meet all applicable federal and state standards for safety and 89
127	127	effectiveness; and 90
128	128	(ii) Comply with all federal tracing procedures; and 91
129	129	(C) Disclose the costs of implementing the program. 92
130	130	(2) (A) If the federal Secretary of Health and Human Services 93
131	131	approves the commissioner's request, the commissioner shall: 94
132	132	(i) Submit to the Commissioner of Public Health a notice disclosing 95
133	133	that the federal Secretary of Health and Human Services has approved 96
134	134	such request; 97
135	135	(ii) Submit to the joint standing committees of the General Assembly 98
136	136	having cognizance of matters relating to appropriations, general law, 99
137	137	human services and public health a notice disclosing that the federal 100
138	138	Secretary of Health and Human Services has approved such request; 101
139	139	and 102
140	140	(iii) Begin operating the program not later than one hundred eighty 103 Raised Bill No. 5366
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146	146	days after the date of such approval. 104
147	147	(B) Except as otherwise provided in this subsection, the 105
148	148	Commissioner of Consumer Protection shall not operate the program 106
149	149	unless the federal Secretary of Health and Human Services approves the 107
150	150	commissioner's request. 108
151	151	Sec. 5. (NEW) (Effective July 1, 2020) (a) Each participating wholesaler 109
152	152	may, subject to the provisions of this section and sections 4 and 7 of this 110
153	153	act, import into this state a legend drug from a participating Canadian 111
154	154	supplier, and distribute such legend drug to a pharmacy or institutional 112
155	155	pharmacy, as both terms are defined in section 20-571 of the general 113
156	156	statutes, or a qualified laboratory in this state, under the program if: 114
157	157	(1) Such participating wholesaler: 115
158	158	(A) Is registered with the federal Secretary of Health and Human 116
159	159	Services pursuant to Section 510(b) of the Food, Drug and Cosmetic Act, 117
160	160	21 USC 360(b), as amended from time to time; and 118
161	161	(B) Holds a valid labeler code that has been issued to such 119
162	162	participating wholesaler by the United States Food and Drug 120
163	163	Administration, or any successor agency; and 121
164	164	(2) Such legend drug: 122
165	165	(A) May be imported into this state in accordance with applicable 123
166	166	federal patent laws; 124
167	167	(B) Meets the United States Food and Drug Administration's, or any 125
168	168	successor agency's, standards concerning drug safety, effectiveness, 126
169	169	misbranding and adulteration; and 127
170	170	(C) Is not: 128
171	171	(i) A controlled substance, as defined in 21 USC 802, as amended from 129
172	172	time to time; 130
173	173	(ii) A biological product, as defined in 42 USC 262, as amended from 131 Raised Bill No. 5366
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176	176
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179	179	time to time; 132
180	180	(iii) An infused drug; 133
181	181	(iv) An intravenously injected drug; 134
182	182	(v) A drug that is inhaled during surgery; or 135
183	183	(vi) A drug that is a parenteral drug, the importation of which is 136
184	184	determined by the federal Secretary of Health and Human Services to 137
185	185	pose a threat to the public health. 138
186	186	(b) Each participating wholesaler shall: 139
187	187	(1) Comply with all applicable track-and-trace requirements, and 140
188	188	make available to the Commissioner of Consumer Protection all track-141
189	189	and-trace records not later than forty-eight hours after the commissioner 142
190	190	requests such records; 143
191	191	(2) Not import, distribute, dispense or sell in this state any legend 144
192	192	drugs under the program except in accordance with the provisions of 145
193	193	this section and sections 4 and 7 of this act; 146
194	194	(3) Not distribute, dispense or sell outside of this state any legend 147
195	195	drugs that are imported into this state under the program; 148
196	196	(4) Ensure the safety and quality of the legend drugs that are 149
197	197	imported and distributed in this state under the program; 150
198	198	(5) For each initial shipment of a legend drug that is imported into 151
199	199	this state by such participating wholesaler, ensure that a qualified 152
200	200	laboratory engaged by such participating wholesaler tests a statistically 153
201	201	valid sample size for each batch of such legend drug in such shipment 154
202	202	for authenticity and degradation in a manner that is consistent with the 155
203	203	Food, Drug and Cosmetic Act; 156
204	204	(6) For each shipment of a legend drug that is imported into this state 157
205	205	by such participating wholesaler, and sampled and tested pursuant to 158
206	206	subdivision (5) of this subsection, ensure that a qualified laboratory 159 Raised Bill No. 5366
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212	212	engaged by such participating wholesaler tests a statistically valid 160
213	213	sample of such legend drug in such shipment for authenticity and 161
214	214	degradation in a manner that is consistent with the Food, Drug and 162
215	215	Cosmetic Act; 163
216	216	(7) Certify to the Commissioner of Consumer Protection that each 164
217	217	legend drug imported into this state under the program: 165
218	218	(A) Is approved for marketing in the United States and not 166
219	219	adulterated or misbranded; and 167
220	220	(B) Meets all labeling requirements under 21 USC 352, as amended 168
221	221	from time to time; 169
222	222	(8) Maintain laboratory records, including, but not limited to, 170
223	223	complete data derived from all tests necessary to ensure that each 171
224	224	legend drug imported into this state under the program satisfies the 172
225	225	requirements of subdivisions (5) and (6) of this subsection; 173
226	226	(9) Maintain documentation demonstrating that the testing required 174
227	227	by subdivisions (5) and (6) of this subsection was conducted at a 175
228	228	qualified laboratory in accordance with the Food, Drug and Cosmetic 176
229	229	Act and all other applicable federal and state laws and regulations 177
230	230	concerning laboratory qualifications; 178
231	231	(10) Maintain the following information for each legend drug that 179
232	232	such participating wholesaler imports and distributes in this state under 180
233	233	the program, and submit such information to the Commissioner of 181
234	234	Consumer Protection upon request by the commissioner: 182
235	235	(A) The name and quantity of the active ingredient of such legend 183
236	236	drug; 184
237	237	(B) A description of the dosage form of such legend drug; 185
238	238	(C) The date on which such participating wholesaler received such 186
239	239	legend drug; 187 Raised Bill No. 5366
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245	245	(D) The quantity of such legend drug that such participating 188
246	246	wholesaler received; 189
247	247	(E) The point of origin and destination of such legend drug; 190
248	248	(F) The price paid by such participating wholesaler for such legend 191
249	249	drug; 192
250	250	(G) A report for any legend drug that fails laboratory testing under 193
251	251	subdivision (5) or (6) of this subsection; and 194
252	252	(H) Such additional information and documentation that the 195
253	253	commissioner deems necessary to ensure the protection of the public 196
254	254	health; and 197
255	255	(11) Maintain all information and documentation that is submitted to 198
256	256	the Commissioner of Consumer Protection pursuant to this subsection 199
257	257	for a period of not less than three years. 200
258	258	Sec. 6. (NEW) (Effective July 1, 2020) Each participating Canadian 201
259	259	supplier shall: 202
260	260	(1) Comply with all applicable track-and-trace requirements; 203
261	261	(2) Not distribute, dispense or sell outside of this state any legend 204
262	262	drugs that are imported into this state under the program; and 205
263	263	(3) Maintain the following information and documentation and, 206
264	264	upon request by the Commissioner of Consumer Protection, submit 207
265	265	such information and documentation to the commissioner for each 208
266	266	legend drug that such participating Canadian supplier exports into this 209
267	267	state under the program: 210
268	268	(A) The original source of such legend drug, including, but not 211
269	269	limited to: 212
270	270	(i) The name of the manufacturer of such legend drug; 213
271	271	(ii) The date on which such legend drug was manufactured; and 214 Raised Bill No. 5366
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277	277	(iii) The location where such legend drug was manufactured; 215
278	278	(B) The date on which such legend drug was shi pped to a 216
279	279	participating wholesaler; 217
280	280	(C) The quantity of such legend drug that was shipped to a 218
281	281	participating wholesaler; 219
282	282	(D) The quantity of each lot of such legend drug that such 220
283	283	participating Canadian supplier originally received and the source of 221
284	284	such lot; 222
285	285	(E) The lot or control number and the batch number assigned to such 223
286	286	legend drug by the manufacturer; and 224
287	287	(F) Such additional information and documentation that the 225
288	288	commissioner deems necessary to ensure the protection of the public 226
289	289	health. 227
290	290	Sec. 7. (NEW) (Effective July 1, 2020) (a) The Commissioner of 228
291	291	Consumer Protection shall issue a written order: 229
292	292	(1) Suspending importation and distribution of a legend drug under 230
293	293	the program if the commissioner discovers that such distribution or 231
294	294	importation violates any provision of sections 4 to 6, inclusive, of this 232
295	295	act or any other applicable state or federal law or regulation; 233
296	296	(2) Suspending all importation and distribution of legend drugs by a 234
297	297	participating wholesaler under the program if the commissioner 235
298	298	discovers that the participating wholesaler has violated any provision 236
299	299	of section 4 or 5 of this act or any other applicable state or federal law or 237
300	300	regulation; 238
301	301	(3) Suspending all importation and distribution of legend drugs by a 239
302	302	participating Canadian supplier under the program if the commissioner 240
303	303	discovers that the participating Canadian supplier has violated any 241
304	304	provision of section 4 or 6 of this act or any other applicable state or 242
305	305	federal law or regulation; or 243 Raised Bill No. 5366
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311	311	(4) Requiring the recall or seizure of any legend drug that was 244
312	312	imported and distributed under the program and has been identified as 245
313	313	adulterated, within the meaning of section 21a-105 of the general 246
314	314	statutes, or misbranded. 247
315	315	(b) The Commissioner of Consumer Protection shall send a notice to 248
316	316	each participating Canadian supplier and participating wholesaler 249
317	317	affected by an order issued pursuant to subsection (a) of this section 250
318	318	notifying such participating Canadian supplier or participating 251
319	319	wholesaler that: 252
320	320	(1) The commissioner has issued such order, and providing the legal 253
321	321	and factual basis for such order; and 254
322	322	(2) Such participating Canadian supplier or participating wholesaler 255
323	323	may request, in writing, a hearing before the commissioner, provided 256
324	324	such request is received by the commissioner not later than thirty days 257
325	325	after the date of such notice. 258
326	326	(c) If a participating Canadian supplier or participating wholesaler 259
327	327	timely requests a hearing pursuant to subsection (b) of this section, the 260
328	328	Commissioner of Consumer Protection shall, not later than thirty days 261
329	329	after the receipt of the request, convene the hearing as a contested case 262
330	330	in accordance with the provisions of chapter 54 of the general statutes. 263
331	331	Not later than sixty days after the receipt of such request, the 264
332	332	commissioner shall issue a final decision vacating, modifying or 265
333	333	affirming the commissioner's order. A participating Canadian supplier 266
334	334	or participating wholesaler aggrieved by a final decision may appeal 267
335	335	such decision in accordance with the provisions of section 4-183 of the 268
336	336	general statutes. 269
337	337	Sec. 8. (NEW) (Effective July 1, 2020) The Commissioner of Consumer 270
338	338	Protection may, in consultation with the Commissioner of Public 271
339	339	Health, adopt regulations in accordance with the provisions of chapter 272
340	340	54 of the general statutes to implement the provisions of sections 3 to 7, 273
341	341	inclusive, of this act. 274 Raised Bill No. 5366
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347	347	Sec. 9. (NEW) (Effective October 1, 2020) (a) Each pharmaceutical 275
348	348	manufacturer doing business in this state that manufactures a brand 276
349	349	name prescription drug and enters into an agreement with another 277
350	350	pharmaceutical manufacturer for the purpose of delaying or preventing 278
351	351	such other manufacturer from introducing a generic substitute for such 279
352	352	drug into the marketplace shall, not later than thirty days after entering 280
353	353	into such agreement, send notice to the Insurance Commissioner, in a 281
354	354	form and manner prescribed by the commissioner, disclosing the name 282
355	355	of such drug. 283
356	356	(b) (1) The commissioner shall, not later than thirty days after 284
357	357	receiving a notice pursuant to subsection (a) of this section, send notice 285
358	358	to each health carrier, as defined in section 38a-1080 of the general 286
359	359	statutes, and pharmacy benefits manager, as defined in section 38a-287
360	360	479aaa of the general statutes, doing business in this state. Such notice 288
361	361	shall, at a minimum: 289
362	362	(A) Disclose the name of the brand name prescription drug that is the 290
363	363	subject of the notice the commissioner received pursuant to subsection 291
364	364	(a) of this section; and 292
365	365	(B) Instruct such health carrier, if such health carrier includes such 293
366	366	drug on such health carrier's drug formulary or list of covered drugs, or 294
367	367	pharmacy benefits manager, if such pharmacy benefits manager 295
368	368	administers a prescription drug benefit that includes such drug, to 296
369	369	immediately reduce the cost of such drug to covered individuals by an 297
370	370	amount that is equal to fifty per cent of the manufacturer's wholesale list 298
371	371	price for such drug. 299
372	372	(2) For the purposes of this subsection, "manufacturer's wholesale list 300
373	373	price" has the same meaning as provided in section 21a-126 of the 301
374	374	general statutes. 302
375	375	(c) The provisions of this section shall apply to the maximum extent 303
376	376	permitted by applicable law. 304
377	377	(d) The commissioner may adopt regulations, in accordance with 305 Raised Bill No. 5366
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383	383	chapter 54 of the general statutes, to implement the provisions of this 306
384	384	section. 307
385	385	Sec. 10. (NEW) (Effective October 1, 2020) (a) There is established a 308
386	386	Critical Drug Shortage Review Board, which shall be part of the 309
387	387	Executive Department. 310
388	388	(b) The board shall consist of the following members: 311
389	389	(1) The Commissioner of Correction; 312
390	390	(2) The Commissioner of Mental Health and Addiction Services; 313
391	391	(3) The Commissioner of Social Services; and 314
392	392	(4) The executive director of the Office of Health Strategy, established 315
393	393	under section 19a-754a of the general statutes. 316
394	394	(b) A majority of the board shall constitute a quorum for the 317
395	395	transaction of any business. 318
396	396	(c) The members of the board shall serve without compensation, but 319
397	397	shall, within the limits of available funds, be reimbursed for expenses 320
398	398	necessarily incurred in the performance of their duties. 321
399	399	(d) The board shall have the following powers and duties: (1) To 322
400	400	evaluate the cost of prescription drugs in this state; (2) to declare a 323
401	401	prescription drug pricing emergency and recommend that the 324
402	402	Commissioner of Public Health request that the federal government 325
403	403	exercise its powers under 28 USC 1498; (3) obtain from any executive 326
404	404	department, board, commission or other agency of the state such 327
405	405	assistance and data as necessary and available to carry out the purposes 328
406	406	of this section; (4) accept any gift, donation or bequest for the purpose 329
407	407	of performing the duties described in this section; and (5) perform such 330
408	408	other acts as may be necessary and appropriate to carry out the duties 331
409	409	described in this section. 332
410	410	(e) The board shall meet as often as deemed necessary by a majority 333 Raised Bill No. 5366
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416	416	of the board. 334
417	417	(f) The board may enter into such contractual agreements as may be 335
418	418	necessary for the discharge of its duties, within the limits of its 336
419	419	appropriated funds and in accordance with established procedures. 337
420	420	Sec. 11. (NEW) (Effective January 1, 2021) (a) For the purposes of this 338
421	421	section: 339
422	422	(1) "Affordable Care Act" has the same meaning as provided in 340
423	423	section 38a-1080 of the general statutes; 341
424	424	(2) "Health benefit plan" has the same meaning as provided in section 342
425	425	38a-1080 of the general statutes, except that such term shall not include 343
426	426	a grandfathered health plan as such term is used in the Affordable Care 344
427	427	Act; and 345
428	428	(3) "Health carrier" has the same meaning as provided in section 38a-346
429	429	1080 of the general statutes. 347
430	430	(b) Notwithstanding any provision of the general statutes and except 348
431	431	as provided in subsection (c) of this section, no health carrier offering a 349
432	432	health benefit plan in this state on or after January 1, 2021, that includes 350
433	433	a pharmacy benefit and uses a drug formulary or list of covered drugs 351
434	434	may: 352
435	435	(1) Remove a prescription drug from the drug formulary or list of 353
436	436	covered drugs during a plan year; or 354
437	437	(2) Move a prescription drug from a cost-sharing tier that imposes a 355
438	438	lesser coinsurance, copayment or deductible for the prescription drug to 356
439	439	a cost-sharing tier that imposes a greater coinsurance, copayment or 357
440	440	deductible for the prescription drug during a plan year, unless the 358
441	441	prescription drug is subject to an in-network coinsurance, copayment or 359
442	442	deductible that is not greater than forty dollars per prescription per 360
443	443	month in any tier. 361
444	444	(c) A health carrier offering a health benefit plan in this state on or 362 Raised Bill No. 5366
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447	447
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450	450	after January 1, 2021, that includes a pharmacy benefit and uses a drug 363
451	451	formulary or list of covered drugs may: 364
452	452	(1) Remove a prescription drug from the drug formulary or list of 365
453	453	covered drugs, upon at least ninety days' advance notice to a covered 366
454	454	person and the covered person's treating physician, if: 367
455	455	(A) The federal Food and Drug Administration issues an 368
456	456	announcement, guidance, notice, warning or statement concerning the 369
457	457	prescription drug that calls into question the clinical safety of the 370
458	458	prescription drug, unless the covered person's treating physician states, 371
459	459	in writing, that the prescription drug remains medically necessary 372
460	460	despite such announcement, guidance, notice, warning or statement; or 373
461	461	(B) The prescription drug is approved by the federal Food and Drug 374
462	462	Administration for use without a prescription; and 375
463	463	(2) Move a brand name prescription drug from a cost-sharing tier that 376
464	464	imposes a lesser coinsurance, copayment or deductible for the brand 377
465	465	name prescription drug to a cost-sharing tier that imposes a greater 378
466	466	coinsurance, copayment or deductible for the brand name prescription 379
467	467	drug if the health carrier adds to the drug formulary or list of covered 380
468	468	drugs a generic prescription drug that is: 381
469	469	(A) Approved by the federal Food and Drug Administration for use 382
470	470	as an alternative to such brand name prescription drug; and 383
471	471	(B) In a cost-sharing tier that imposes a coinsurance, copayment or 384
472	472	deductible for the generic prescription drug that is lesser than the 385
473	473	coinsurance, copayment or deductible that is imposed for such brand 386
474	474	name prescription drug. 387
475	475	(d) Nothing in this section shall prevent or prohibit a health carrier 388
476	476	from adding a prescription drug to a formulary or list of covered drugs 389
477	477	at any time. 390 Raised Bill No. 5366
478	478
479	479
480	480
481	481	LCO No. 2027 15 of 15
482	482
483	483	This act shall take effect as follows and shall amend the following
484	484	sections:
485	485
486	486	Section 1 January 1, 2021 New section
487	487	Sec. 2 January 1, 2021 New section
488	488	Sec. 3 July 1, 2020 New section
489	489	Sec. 4 July 1, 2020 New section
490	490	Sec. 5 July 1, 2020 New section
491	491	Sec. 6 July 1, 2020 New section
492	492	Sec. 7 July 1, 2020 New section
493	493	Sec. 8 July 1, 2020 New section
494	494	Sec. 9 October 1, 2020 New section
495	495	Sec. 10 October 1, 2020 New section
496	496	Sec. 11 January 1, 2021 New section
497	497
498	498	Statement of Purpose:
499	499	To: (1) Cap aggregate monthly cost-sharing for prescription drugs
500	500	covered under certain individual and group health insurance policies;
501	501	(2) cap the cost of generic drugs in this state; (3) require the
502	502	Commissioner of Consumer Protection to submit a request to the federal
503	503	Secretary of Health and Human Services to implement a Canadian
504	504	prescription drug reimportation program in this state and, if the
505	505	secretary approves such request, implement such program in this state;
506	506	(4) require pharmaceutical manufacturers to send notice to the
507	507	Insurance Commissioner regarding "pay-for-delay" agreements, and
508	508	require health carriers and pharmacy benefits managers to reduce the
509	509	cost of brand name prescription drugs that are the subject of such
510	510	agreements; (5) establish a Critical Drug Shortage Review Board; and (6)
511	511	limit the circumstances in which a health carrier may remove a
512	512	prescription drug from a drug formulary or list of covered drugs, or
513	513	move a prescription drug to a different cost-sharing tier, during a plan
514	514	year.
515	515	[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
516	516	that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
517	517	underlined.]
518	518