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General Assembly Substitute Bill No. 6870
January Session, 2025
AN ACT ADDRESSING PATIENTS' PRESCRIPTION DRUG COSTS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (Effective July 1, 2025) For the purposes of this section and 1
sections 2 to 10, inclusive, of this act, unless the context otherwise 2
requires: 3
(1) "Canadian supplier" means a manufacturer or wholesale drug 4
distributor that is licensed or permitted under applicable Canadian law 5
to manufacture or distribute prescription drugs; 6
(2) "Canadian prescription drug importation program" or "program" 7
means a program under which the state would seek federal approval to 8
import prescription drugs from Canada that have the highest potential 9
for cost savings in the state; 10
(3) "Department" means the Department of Consumer Protection; 11
(4) "Drug" means an article that is (A) recognized in the official United 12
States Pharmacopoeia, official Homeopathic Pharmacopoeia of the 13
United States or official National Formulary, or any supplement thereto, 14
(B) intended for use in the diagnosis, cure, mitigation, treatment or 15
prevention of disease in humans, (C) not food and intended to affect the 16
structure or any function of the human body, and (D) not a device and 17
intended for use as a component of any article specified in 18 Substitute Bill No. 6870
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subparagraphs (A) to (C), inclusive, of this subdivision; 19
(5) "Drug Quality and Security Act" means the federal Drug Quality 20
and Security Act, 21 USC 351, et seq., as amended from time to time; 21
(6) "Food, Drug and Cosmetic Act" means the federal Food, Drug and 22
Cosmetic Act, 21 USC 301, et seq., as amended by the Drug Quality and 23
Security Act, as both may be amended from time to time; 24
(7) "Qualifying laboratory" has the same meaning as provided in 21 25
CFR 251.2; 26
(8) "Laboratory testing" means a quantitative and qualitative analysis 27
of a drug consistent with the applicable provisions of the official United 28
States Pharmacopoeia; 29
(9) "Participating Canadian supplier" means a Canadian supplier that 30
is exporting prescription drugs, in the manufacturer's original 31
container, to a participating wholesaler for distribution in this state 32
under the program; 33
(10) "Participating wholesaler" means a wholesaler that is (A) 34
designated by the Department of Consumer Protection to distribute 35
prescription drugs in the manufacturer's original container, obtained 36
from a participating Canadian supplier, and (B) participating in the 37
program; 38
(11) "Recall" means a person's removal or correction of a marketed 39
product that the department determines is in violation of this section, 40
but "recall" does not include a market withdrawal or a stock recovery, 41
as such terms are defined in 21 CFR 7.3; 42
(12) "Relabeler" has the same meaning as provided in 21 CFR 207.1; 43
(13) "Repacker" has the same meaning as provided in 21 CFR 207.1; 44
(14) "Track-and-trace" means the product tracing process for the 45
components of the pharmaceutical distribution supply chain as 46 Substitute Bill No. 6870
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described in Title II of the Drug Quality and Security Act; and 47
(15) "Wholesaler" means a wholesaler, as defined in section 21a-70 of 48
the general statutes, that has received a certificate of registration from 49
the Commissioner of Consumer Protection pursuant to said section. 50
Sec. 2. (Effective July 1, 2025) The Commissioner of Consumer 51
Protection shall hire, within available resources, a consultant to study 52
the feasibility of establishing a Canadian prescription drug importation 53
program to reduce prescription drug costs in the state. Not later than 54
October 1, 2027, the Commissioner shall file a report, in accordance with 55
the provisions of section 11-4a of the general statutes, with the joint 56
standing committees of the General Assembly having cognizance of 57
matters relating to appropriations and the budgets of state agencies, 58
general law and human services and the Office of Policy and 59
Management on the results of the feasibility study. 60
Sec. 3. (Effective October 1, 2027) (a) If after completion of the study 61
described in section 2 of this act, the Commissioner of Consumer 62
Protection, in consultation with the Secretary of the Office of Policy and 63
Management, determines a Canadian prescription drug importation 64
program is feasible, the Commissioner of Consumer Protection may 65
submit a request to the federal Food and Drug Administration seeking 66
approval for the program under Section 804 of the federal Food, Drug 67
and Cosmetic Act, 21 USC 384(b) to 21 USC 384(h), inclusive, as 68
amended from time to time. If submitted, such request shall, at a 69
minimum: 70
(1) Describe the state's plans for operating the program and describe 71
any opportunities to coordinate or operate the program in coordination 72
with other states; 73
(2) Demonstrate that any prescription drug that is imported and 74
distributed in this state under the program would: 75
(A) Meet all applicable federal and state standards for safety and 76
effectiveness; and 77 Substitute Bill No. 6870
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(B) Comply with all federal tracing procedures; and 78
(3) State the estimated costs of implementing the program. 79
(b) If the federal Food and Drug Administration approves the 80
request, the Commissioner of Consumer Protection shall: 81
(1) Submit to the Secretary of the Office of Policy and Management, 82
and the Commissioners of Social Services and Health Strategy, a notice 83
disclosing that the federal Food and Drug Administration approved 84
such request; and 85
(2) Submit to the joint standing committees of the General Assembly 86
having cognizance of matters relating to appropriations and the budgets 87
of state agencies, general law, human services and public health a notice 88
disclosing that the federal Food and Drug Administration approved 89
such request. 90
(c) The Commissioner of Consumer Protection shall not operate the 91
program unless the federal Food and Drug Administration approves the 92
request. Notwithstanding the foregoing, the department may expend 93
resources in advance of such approval to ensure efficient 94
implementation. 95
Sec. 4. (Effective October 1, 2027) If the Canadian prescription drug 96
importation program is established, each participating wholesaler may 97
import and distribute a prescription drug in this state from a 98
participating Canadian supplier under the program if: 99
(1) Such drug meets the federal Food and Drug Administration's 100
standards concerning drug safety, effectiveness, misbranding and 101
adulteration; 102
(2) Importing such drug would not violate federal patent laws; and 103
(3) Such drug is not: 104
(A) A controlled substance, as defined in 21 USC 802, as amended 105 Substitute Bill No. 6870
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from time to time; 106
(B) A biological product, as defined in 42 USC 262, as amended from 107
time to time; 108
(C) An infused drug; 109
(D) An intravenously injected drug; 110
(E) A drug that is inhaled during surgery; or 111
(F) A drug that is a parenteral drug, the importation of which is 112
determined by the federal Secretary of Health and Human Services to 113
pose a threat to the public health. 114
Sec. 5. (Effective October 1, 2027) If a Canadian prescription drug 115
importation program is established, participating wholesalers may, 116
subject to the provisions of sections 1 to 4, inclusive, and sections 6 to 117
10, inclusive, of this act, import and distribute drugs in this state from a 118
participating Canadian supplier under the program to: 119
(1) A pharmacy or institutional pharmacy, as defined in section 20-120
571 of the general statutes; and 121
(2) A qualifying laboratory. 122
Sec. 6. (Effective October 1, 2027) If a Canadian prescription drug 123
importation program is established, the Commissioner of Consumer 124
Protection shall require that each participating Canadian supplier and 125
participating wholesaler (1) comply with all applicable track-and-trace 126
requirements, and shall not distribute, dispense or sell outside of this 127
state any prescription drug that is imported into this state under the 128
program, and (2) make available to the commissioner all track-and-trace 129
records not later than forty-eight hours after the commissioner requests 130
such records. 131
Sec. 7. (Effective October 1, 2027) (a) A participating wholesaler in any 132
approved Canadian prescription drug importation program shall 133 Substitute Bill No. 6870
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ensure the safety and quality of all drugs that may be imported and 134
distributed in this state under the program. The participating 135
wholesaler shall, if such program is established: 136
(1) For each initial shipment of a drug that is imported into this state 137
by a participating wholesaler, ensure that a qualifying laboratory 138
engaged by the participating wholesaler tests a statistically valid sample 139
size for each batch of each drug in such shipment for authenticity and 140
degradation in a manner that is consistent with the Food, Drug and 141
Cosmetic Act; 142
(2) For each shipment of a drug that is imported into this state by a 143
participating wholesaler and has been sampled and tested pursuant to 144
subdivision (1) of this subsection, ensure that a qualifying laboratory 145
engaged by the participating wholesaler tests a statistically valid sample 146
of such shipment for authenticity and degradation in a manner that is 147
consistent with the Food, Drug and Cosmetic Act; 148
(3) Only import drugs into this state that are (A) approved for 149
marketing in the United States, (B) not adulterated or misbranded, and 150
(C) meet all of the labeling requirements under 21 USC 352, as amended 151
from time to time; 152
(4) Maintain qualifying laboratory records, including, but not limited 153
to, complete data derived from all tests necessary to ensure that each 154
drug imported into this state under any approved Canadian 155
prescription drug importation program is in compliance with the 156
requirements of this section; and 157
(5) Maintain documentation demonstrating that the testing required 158
by this section was conducted at a qualifying laboratory in accordance 159
with the Food, Drug and Cosmetic Act and all other applicable federal 160
and state laws and regulations concerning qualifying laboratory 161
qualifications. 162
(b) The participating wholesaler shall maintain all information and 163
documentation pursuant to this section for a period of not less than three 164 Substitute Bill No. 6870
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years from the date of submission of such information and 165
documentation to the participating wholesaler by a qualifying 166
laboratory. 167
(c) Each participating wholesaler shall maintain all of the following 168
information for each drug that such participating wholesaler imports 169
and distributes in this state under the program, and submit such 170
information to the Commissioner of Consumer Protection upon request 171
by the commissioner: 172
(1) The name and quantity of the active ingredient of such drug; 173
(2) A description of the dosage form of such drug; 174
(3) The date on which such participating wholesaler received such 175
drug; 176
(4) The quantity of such drug that such participating wholesaler 177
received; 178
(5) The point of origin and destination of such drug; 179
(6) The price paid by such participating wholesaler for such drug; 180
(7) A report regarding any drug that fails qualifying laboratory 181
testing; and 182
(8) Such additional information and documentation that the 183
commissioner deems necessary to ensure the protection of the public 184
health. 185
(d) The Commissioner of Consumer Protection shall require each 186
participating Canadian supplier in any approved Canadian prescription 187
drug importation program to maintain the following information and 188
documentation and, upon request by the commissioner, submit such 189
information and documentation to the commissioner for each drug that 190
such participating Canadian supplier exports into this state under the 191
program: 192 Substitute Bill No. 6870
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(1) The original source of such drug, including, but not limited to: 193
(A) The name of the manufacturer of such drug; 194
(B) The date on which such drug was manufactured; and 195
(C) The location where such drug was manufactured; 196
(2) The date on which such drug was shipped; 197
(3) The quantity of such drug that was shipped; 198
(4) The quantity of each lot of such drug originally received and the 199
source of such lot; 200
(5) The lot or control number and the batch number assigned to such 201
drug by the manufacturer; and 202
(6) Such additional information and documentation that the 203
Commissioner of Consumer Protection deems necessary to ensure the 204
protection of the public health. 205
Sec. 8. (Effective October 1, 2027) (a) If the Commissioner of Consumer 206
Protection determines that public health, safety or welfare requires 207
emergency action, the commissioner may order a participating 208
Canadian supplier, participating wholesaler, relabeler, repacker and 209
qualifying laboratory to cease and desist from actions specified in the 210
order that create the need for such emergency action pending 211
administrative proceedings. Such cease and desist order shall be (1) in 212
writing; (2) signed by the Commissioner of Consumer Protection; and 213
(3) effective upon delivery to the respondent. An administrative 214
proceeding conducted in accordance with chapter 54 of the general 215
statutes shall be promptly instituted following a cease and desist order. 216
The commissioner may impose a civil penalty, in an amount not to 217
exceed ten thousand dollars, after a hearing conducted pursuant to 218
chapter 54 of the general statutes. 219
(b) The commissioner may require the recall, embargo or destruction, 220 Substitute Bill No. 6870
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pursuant to section 21a-96 of the general statutes, of any drug that was 221
imported and distributed under the program and has been identified as 222
adulterated, within the meaning of section 21a-105 of the general 223
statutes, or misbranded. 224
(c) In the event of a cease and desist, recall, embargo or destruction 225
order, the person adversely impacted by such order shall provide 226
written notice to all other businesses participating in the program, 227
informing them of the order. 228
Sec. 9. (Effective October 1, 2027) If a Canadian prescription drug 229
importation program is established, the Commissioner of Consumer 230
Protection may adopt regulations in accordance with the provisions of 231
chapter 54 of the general statutes to implement the provisions of sections 232
1 to 8, inclusive, and section 10 of this act. 233
Sec. 10. (Effective October 1, 2027) Not later than one hundred eighty 234
days after the first importation of any Canadian prescription drug under 235
the importation program begins, and biannually thereafter, the 236
Commissioner of Consumer Protection shall submit a report, in 237
accordance with the provisions of section 11-4a of the general statutes, 238
to the joint standing committees of the General Assembly having 239
cognizance of matters relating to appropriations and the budgets of state 240
agencies, general law, human services and public health. Such report 241
shall describe (1) the operation of the program, if established, and (2) 242
any violation of sections 1 to 9, inclusive, of this act that resulted in any 243
action taken by the commissioner pursuant to section 8 of this act and 244
the status of the investigation into such violation. 245
Sec. 11. (NEW) (Effective July 1, 2025) For the purposes of this section 246
and sections 12 to 14, inclusive, of this act: 247
(1) "Biological product" has the same meaning as provided in section 248
20-619 of the general statutes; 249
(2) "Brand-name drug" means a drug that is produced or distributed 250
in accordance with an original new drug application approved under 21 251 Substitute Bill No. 6870
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USC 355, as amended from time to time, but does not include an 252
authorized generic drug as defined in 42 CFR 447.502, as amended from 253
time to time; 254
(3) "Commissioner" means the Commissioner of Revenue Services; 255
(4) "Consumer price index" means the consumer price index, annual 256
average, for all urban consumers: United States city average, all items, 257
published by the United States Department of Labor, Bureau of Labor 258
Statistics, or its successor, or, if the index is discontinued, an equivalent 259
index published by a federal authority, or, if no such index is published, 260
a comparable index published by the United States Department of 261
Labor, Bureau of Labor Statistics; 262
(5) "Generic drug" means (A) a prescription drug product that is 263
marketed or distributed in accordance with an abbreviated new drug 264
application approved under 21 USC 355, as amended from time to time, 265
(B) an authorized generic drug as defined in 42 CFR 447.502, as 266
amended from time to time, or (C) a drug that entered the market before 267
calendar year 1962 that was not originally marketed under a new 268
prescription drug product application; 269
(6) "Identified prescription drug" means (A) a brand-name drug or 270
biological product for which the patent has expired for at least twenty-271
four months, or (B) a generic drug or interchangeable biological 272
product; 273
(7) "Interchangeable biological product" has the same meaning as 274
provided in section 20-619 of the general statutes; 275
(8) "Person" has the same meaning as provided in section 12-1 of the 276
general statutes; 277
(9) "Pharmaceutical manufacturer" means a person that 278
manufactures a prescription drug and sells, directly or through another 279
person, the prescription drug for distribution in this state; 280
(10) "Prescription drug" means a legend drug, as defined in section 281 Substitute Bill No. 6870
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20-571 of the general statutes, approved by the federal Food and Drug 282
Administration, or any successor agency, and prescribed by a health 283
care provider to an individual in this state; 284
(11) "Reference price" means the wholesale acquisition cost, as 285
defined in 42 USC 1395w-3a, as amended from time to time, of (A) a 286
brand-name drug or biological product (i) on January 1, 2025, if the 287
patent for the brand-name drug or biological product expired on or 288
before said date, or (ii) if the patent for the brand-name drug or 289
biological product expires after January 1, 2025, on the date the patent 290
for such brand-name drug or biological product expires, or (B) a generic 291
drug or interchangeable biological product (i) on January 1, 2025, or (ii) 292
if the generic drug or interchangeable biological product is first 293
commercially marketed in the United States after January 1, 2025, on the 294
date such generic drug or interchangeable biological product is first 295
commercially marketed in the United States; and 296
(12) "Wholesale distributor" means a person, including, but not 297
limited to, a repacker, own-label distributor, private-label distributor or 298
independent wholesale drug trader, engaged in the wholesale 299
distribution of prescription drugs. 300
Sec. 12. (NEW) (Effective July 1, 2025) (a) (1) Notwithstanding any 301
provision of the general statutes and except as provided in subdivision 302
(2) of this subsection, no pharmaceutical manufacturer or wholesale 303
distributor shall, on or after January 1, 2026, sell an identified 304
prescription drug in this state at a price that exceeds the reference price 305
for the identified prescription drug, adjusted for any increase in the 306
consumer price index. 307
(2) A pharmaceutical manufacturer or wholesale distributor may, on 308
or after January 1, 2026, sell an identified prescription drug in this state 309
at a price that exceeds the reference price for the identified prescription 310
drug, adjusted for any increase in the consumer price index, if the 311
federal Secretary of Health and Human Services determines, pursuant 312
to 21 USC 356e, as amended from time to time, that such identified 313 Substitute Bill No. 6870
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prescription drug is in shortage in the United States. 314
(b) (1) Except as provided in subdivision (2) of this subsection, any 315
pharmaceutical manufacturer or wholesale distributor that violates the 316
provisions of subsection (a) of this section shall be liable to this state for 317
a civil penalty. Such civil penalty shall be imposed, calculated and 318
collected on a calendar year basis by the commissioner, and the amount 319
of such civil penalty for a calendar year shall be equal to eighty per cent 320
of the difference between: 321
(A) The revenue that the pharmaceutical manufacturer or wholesale 322
distributor earned from all sales of the identified prescription drug in 323
this state during the calendar year; and 324
(B) The revenue that the pharmaceutical manufacturer or wholesale 325
distributor would have earned from all sales of the identified 326
prescription drug in this state during the calendar year if the 327
pharmaceutical manufacturer or wholesale distributor had sold such 328
identified prescription drug at a price that did not exceed the reference 329
price for such identified prescription drug, as such reference price is 330
adjusted for any increase in the consumer price index. 331
(2) No pharmaceutical manufacturer or wholesale distributor of an 332
identified prescription drug shall be liable to this state for the civil 333
penalty imposed under subdivision (1) of this subsection unless the 334
pharmaceutical manufacturer or wholesale distributor made at least 335
two hundred fifty thousand dollars in total annual sales in this state for 336
the calendar year for which such civil penalty would otherwise be 337
imposed. 338
(c) (1) (A) For calendar years commencing on or after January 1, 2026, 339
each pharmaceutical manufacturer or wholesale distributor that 340
violated the provisions of subsection (a) of this section during any 341
calendar year shall, not later than the first day of March immediately 342
following the end of such calendar year: 343
(i) Pay to the commissioner the civil penalty imposed under 344 Substitute Bill No. 6870
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subsection (b) of this section for such calendar year; and 345
(ii) File with the commissioner a statement for such calendar year in 346
a form and manner, and containing all information, prescribed by the 347
commissioner. 348
(B) A pharmaceutical manufacturer or wholesale distributor that is 349
required to file the statement and pay the civil penalty pursuant to 350
subparagraph (A) of this subdivision shall electronically file such 351
statement and make such payment by electronic funds transfer in the 352
manner provided by chapter 228g of the general statutes, irrespective of 353
whether the pharmaceutical manufacturer or wholesale distributor 354
would have otherwise been required to electronically file such 355
statement or make such payment by electronic funds transfer under 356
chapter 228g of the general statutes. 357
(2) If no statement is filed pursuant to subdivision (1) of this 358
subsection, the commissioner may make such statement at any time 359
thereafter, according to the best obtainable information and the 360
prescribed form. 361
(d) The commissioner may examine the records of any 362
pharmaceutical manufacturer or wholesale distributor that is subject to 363
the civil penalty imposed under subsection (b) of this section as the 364
commissioner deems necessary. If the commissioner determines from 365
such examination that the pharmaceutical manufacturer or wholesale 366
distributor failed to pay the full amount of such civil penalty, the 367
commissioner shall bill such pharmaceutical manufacturer or wholesale 368
distributor for the full amount of such civil penalty. 369
(e) (1) The commissioner may require each pharmaceutical 370
manufacturer or wholesale distributor that is subject to the civil penalty 371
imposed under subsection (b) of this section to keep such records as the 372
commissioner may prescribe, and produce books, papers, documents 373
and other data, to provide or secure information pertinent to the 374
enforcement and collection of such civil penalty. 375 Substitute Bill No. 6870
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(2) The commissioner, or the commissioner's authorized 376
representative, may examine the books, papers, records and equipment 377
of any person who is subject to the provisions of this section and may 378
investigate the character of the business of such person to verify the 379
accuracy of any statement made or, if no statement is made by such 380
person, to ascertain and determine the amount of the civil penalty due 381
under subsection (b) of this section. 382
(f) Any pharmaceutical manufacturer or wholesale distributor that is 383
subject to the civil penalty imposed under subsection (b) of this section 384
and aggrieved by any action of the commissioner under subdivision (2) 385
of subsection (c) of this section or subsection (d) of this section may 386
apply to the commissioner, in writing and not later than sixty days after 387
the notice of such action is delivered or mailed to such pharmaceutical 388
manufacturer or wholesale distributor, for a hearing, setting forth the 389
reasons why such hearing should be granted and if such pharmaceutical 390
manufacturer or wholesale distributor believes that such 391
pharmaceutical manufacturer or wholesale distributor is not liable for 392
such civil penalty or the full amount of such civil penalty, the grounds 393
for such belief and the amount by which such pharmaceutical 394
manufacturer or wholesale distributor believes such civil penalty 395
should be reduced. The commissioner shall promptly consider each 396
such application and may grant or deny the hearing requested. If the 397
hearing request is denied, the commissioner shall immediately notify 398
the pharmaceutical manufacturer or wholesale distributor. If the 399
hearing request is granted, the commissioner shall notify the 400
pharmaceutical manufacturer or wholesale distributor of the date, time 401
and place for such hearing. After such hearing, the commissioner may 402
make such order as appears just and lawful to the commissioner and 403
shall furnish a copy of such order to the pharmaceutical manufacturer 404
or wholesale distributor. The commissioner may, by notice in writing, 405
order a hearing on the commissioner's own initiative and require a 406
pharmaceutical manufacturer or wholesale distributor, or any other 407
person who the commissioner believes to be in possession of relevant 408
information concerning such pharmaceutical manufacturer or 409 Substitute Bill No. 6870
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wholesale distributor, to appear before the commissioner or the 410
commissioner's authorized agent with any specified books of account, 411
papers or other documents for examination under oath. 412
(g) Any pharmaceutical manufacturer or wholesale distributor that is 413
aggrieved by any order, decision, determination or disallowance of the 414
commissioner made under subsection (f) of this section may, not later 415
than thirty days after service of notice of such order, decision, 416
determination or disallowance, take an appeal therefrom to the superior 417
court for the judicial district of New Britain, which appeal shall be 418
accompanied by a citation to the commissioner to appear before said 419
court. Such citation shall be signed by the same authority and such 420
appeal shall be returnable at the same time and served and returned in 421
the same manner as is required in case of a summons in a civil action. 422
The authority issuing the citation shall take from the appellant a bond 423
or recognizance to this state, with surety, to prosecute the appeal to 424
effect and to comply with the orders and decrees of the court. Such 425
appeals shall be preferred cases, to be heard, unless cause appears to the 426
contrary, at the first session, by the court or by a committee appointed 427
by the court. Said court may grant such relief as may be equitable and, 428
if the civil penalty was paid prior to the granting of such relief, may 429
order the Treasurer to pay the amount of such relief. If the appeal was 430
taken without probable cause, the court may tax double or triple costs, 431
as the case demands and, upon all such appeals that are denied, costs 432
may be taxed against such pharmaceutical manufacturer or wholesale 433
distributor at the discretion of the court but no costs shall be taxed 434
against this state. 435
(h) The commissioner, and any agent of the commissioner duly 436
authorized to conduct any inquiry, investigation or hearing pursuant to 437
this section, shall have power to administer oaths and take testimony 438
under oath relative to the matter of inquiry or investigation. At any 439
hearing ordered by the commissioner, the commissioner, or the 440
commissioner's agent authorized to conduct such hearing and having 441
authority by law to issue such process, may subpoena witnesses and 442
require the production of books, papers and documents pertinent to 443 Substitute Bill No. 6870
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such inquiry or investigation. No witness under any subpoena 444
authorized to be issued under the provisions of this section shall be 445
excused from testifying or from producing books, papers or 446
documentary evidence on the ground that such testimony or the 447
production of such books, papers or documentary evidence would tend 448
to incriminate such witness, but such books, papers or documentary 449
evidence so produced shall not be used in any criminal proceeding 450
against such witness. If any person disobeys such process or, having 451
appeared in obedience thereto, refuses to answer any pertinent question 452
put to such person by the commissioner, or the commissioner's 453
authorized agent, or to produce any books, papers or other 454
documentary evidence pursuant thereto, the commissioner, or such 455
agent, may apply to the superior court of the judicial district wherein 456
the pharmaceutical manufacturer or wholesale distributor resides or 457
wherein the business was conducted, or to any judge of such court if the 458
same is not in session, setting forth such disobedience to process or 459
refusal to answer, and such court or such judge shall cite such person to 460
appear before such court or such judge to answer such question or to 461
produce such books, papers or other documentary evidence and, upon 462
such person's refusal to do so, shall commit such person to a community 463
correctional center until such person testifies, but not for a period longer 464
than sixty days. Notwithstanding the serving of the term of such 465
commitment by any person, the commissioner may proceed in all 466
respects with such inquiry and examination as if the witness had not 467
previously been called upon to testify. Officers who serve subpoenas 468
issued by the commissioner or under the commissioner's authority and 469
witnesses attending hearings conducted by the commissioner pursuant 470
to this section shall receive fees and compensation at the same rates as 471
officers and witnesses in the courts of this state, to be paid on vouchers 472
of the commissioner on order of the Comptroller from the proper 473
appropriation for the administration of this section. 474
(i) The amount of any civil penalty unpaid under the provisions of 475
this section may be collected under the provisions of section 12-35 of the 476
general statutes. The warrant provided under section 12-35 of the 477 Substitute Bill No. 6870
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general statutes shall be signed by the commissioner or the 478
commissioner's authorized agent. The amount of any such civil penalty 479
shall be a lien on the real property of the pharmaceutical manufacturer 480
or wholesale distributor from the last day of the month next preceding 481
the due date of such civil penalty until such civil penalty is paid. The 482
commissioner may record such lien in the records of any town in which 483
the real property of such pharmaceutical manufacturer or wholesale 484
distributor is situated, but no such lien shall be enforceable against a 485
bona fide purchaser or qualified encumbrancer of such real property. 486
When any civil penalty with respect to which a lien was recorded under 487
the provisions of this subsection is satisfied, the commissioner shall, 488
upon request of any interested party, issue a certificate discharging such 489
lien, which certificate shall be recorded in the same office in which such 490
lien was recorded. Any action for the foreclosure of such lien shall be 491
brought by the Attorney General in the name of this state in the superior 492
court for the judicial district in which the real property subject to such 493
lien is situated, or, if such real property is located in two or more judicial 494
districts, in the superior court for any one such judicial district, and the 495
court may limit the time for redemption or order the sale of such real 496
property or make such other or further decree as the court judges 497
equitable. The provisions of section 12-39g of the general statutes shall 498
apply to all civil penalties imposed under this section. 499
(j) (1) Any officer or employee of a pharmaceutical manufacturer or 500
wholesale distributor who owes a duty to the pharmaceutical 501
manufacturer or wholesale distributor to pay the civil penalty imposed 502
under subsection (b) of this section on behalf of such pharmaceutical 503
manufacturer or wholesale distributor, file a statement with the 504
commissioner pursuant to subsection (c) of this section on behalf of such 505
pharmaceutical manufacturer or wholesale distributor, keep records or 506
supply information to the commissioner on behalf of such 507
pharmaceutical manufacturer or wholesale distributor pursuant to this 508
section and wilfully fails, at the time required under this section, to pay 509
such civil penalty, file such statement, keep such records or supply such 510
information on behalf of such pharmaceutical manufacturer or 511 Substitute Bill No. 6870
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wholesale distributor shall, in addition to any other penalty provided 512
by law, be fined not more than one thousand dollars or imprisoned not 513
more than one year, or both. Notwithstanding the provisions of section 514
54-193 of the general statutes, no such officer or employee shall be 515
prosecuted for a violation of the provisions of this subdivision 516
committed on or after January 1, 2026, except within three years next 517
after such violation is committed. 518
(2) Any officer or employee of a pharmaceutical manufacturer or 519
wholesale distributor who owes a duty to the pharmaceutical 520
manufacturer or wholesale distributor to deliver or disclose to the 521
commissioner, or the commissioner's authorized agent, any list, 522
statement, return, account statement or other document on behalf of 523
such pharmaceutical manufacturer or wholesale distributor and 524
wilfully delivers or discloses to the commissioner, or the commissioner's 525
authorized agent, any such list, statement, return, account statement or 526
other document that such officer or employee knows to be fraudulent 527
or false in any material matter shall, in addition to any other penalty 528
provided by law, be guilty of a class D felony. 529
(3) No officer or employee of a pharmaceutical manufacturer or 530
wholesale distributor shall be charged with an offense under both 531
subdivisions (1) and (2) of this subsection in relation to the same civil 532
penalty, but such officer or employee may be charged and prosecuted 533
for both such offenses upon the same information. 534
(k) Each civil penalty imposed under subsection (b) of this section 535
shall be deemed to constitute a civil fine or penalty within the meaning 536
of 42 USC 1396b(w), as amended from time to time. No portion of any 537
civil penalty imposed under subsection (b) of this section shall be 538
waived under section 12-3a of the general statutes or any other 539
applicable law. No tax credit shall be allowable against any civil penalty 540
imposed under subsection (b) of this section. 541
(l) Not later than July 1, 2027, and annually thereafter, the 542
commissioner shall prepare a list containing the name of each 543 Substitute Bill No. 6870
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pharmaceutical manufacturer or wholesale distributor that violated 544
subsection (a) of this section during the preceding calendar year. The 545
commissioner shall make each such list publicly available. 546
(m) The commissioner may adopt regulations, in accordance with the 547
provisions of chapter 54 of the general statutes, to implement the 548
provisions of this section. 549
Sec. 13. (NEW) (Effective July 1, 2025) (a) No pharmaceutical 550
manufacturer or wholesale distributor of an identified prescription drug 551
shall withdraw the identified prescription drug from sale in this state 552
for the purpose of avoiding the civil penalty established in subsection 553
(b) of section 12 of this act. 554
(b) Any pharmaceutical manufacturer or wholesale distributor that 555
intends to withdraw an identified prescription drug from sale in this 556
state shall, at least one hundred eighty days before such withdrawal, 557
send advance written notice to the Office of Health Strategy disclosing 558
such pharmaceutical manufacturer's or wholesale distributor's 559
intention. 560
(c) Any pharmaceutical manufacturer or wholesale distributor that 561
violates the provisions of subsection (a) or (b) of this section shall be 562
liable to this state for a civil penalty in the amount of five hundred 563
thousand dollars. 564
Sec. 14. (NEW) (Effective July 1, 2025) All civil penalties collected from 565
pharmaceutical manufacturers or wholesale distributors under sections 566
11 to 13, inclusive, of this act shall be deposited in the General Fund and 567
expended for the purposes of promoting access to affordable health 568
care, and reducing the health care costs borne by patients, in this state. 569
Sec. 15. (NEW) (Effective January 1, 2026) (a) As used in this section: 570
(1) "Enrollee" has the same meaning as provided in section 38a-478 of 571
the general statutes; 572
(2) "Health benefit plan" has the same meaning as provided in section 573 Substitute Bill No. 6870
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38a-472f of the general statutes; and 574
(3) "Health carrier" has the same meaning as provided in section 38a-575
591a of the general statutes. 576
(b) Each insurer, health care center, hospital service corporation, 577
medical service corporation, fraternal benefit society or other entity that 578
delivers, issues for delivery, renews, amends or continues an individual 579
or a group health insurance policy or health benefit plan in this state on 580
or after January 1, 2026, providing coverage of the type specified in 581
subdivisions (1), (2), (4), (11) and (12) of section 38a-469 of the general 582
statutes in this state, shall, when calculating an insured's or enrollee's 583
in-network liability for such insured's or enrollee's annual coinsurance, 584
copayment, deductible or other in-network out-of-pocket expense, give 585
credit for any out-of-pocket expense such insured or enrollee pays 586
directly to any pharmacy licensed pursuant to section 20-594 of the 587
general statutes, or health care provider licensed in this state, for any 588
prescription drug, provided (1) no claim for such prescription drug was 589
submitted to such insurer, center, corporation, society, or other entity, 590
and (2) such out-of-pocket expense paid by such insured or enrollee to 591
such pharmacy or health care provider is less than the average 592
discounted rate for such prescription drug paid to an in-network health 593
care provider pursuant to the terms of such health insurance policy or 594
health benefit plan. 595
(c) If any insured or enrollee purchases a prescription drug from any 596
out-of-network health care provider for a lower amount than the 597
average amount paid by such insured's or enrollee's health carrier to any 598
in-network health care provider for the same prescription drug, such 599
health carrier, when calculating such insured's or enrollee's liability for 600
such insured's or enrollee's in-network annual coinsurance, copayment, 601
deductible or other out-of-pocket expense, shall give credit for such 602
purchase, provided such insured or enrollee provides such health 603
carrier with proof of payment for such prescription drug in accordance 604
with the provisions of subsection (d) of this section. Nothing in this 605
subsection shall be construed to restrict any health insurance policy or 606 Substitute Bill No. 6870
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health benefit plan from requiring a prior authorization or 607
precertification otherwise provided for in the insured's or enrollee's 608
health insurance policy or health benefit plan. 609
(d) Each health carrier shall (1) develop a proof of payment form and 610
publish such form on such health carrier's Internet web site for insureds 611
and enrollees to submit proof of payment for any out-of-network 612
prescription drug purchase pursuant to subsection (c) of this section, 613
and (2) annually provide to such insureds and enrollees written notice 614
of, and instructions for downloading or electronic submission of, such 615
proof of payment form. 616
(e) Upon receipt of any such proof of payment form submitted by any 617
insured or enrollee pursuant to subsection (d) of this section, each health 618
carrier shall give credit for any out-of-pocket payments that such 619
insured or enrollee paid to any out-of-network pharmacy or health care 620
provider in accordance with the provisions of subsection (c) of this 621
section, provided (1) the prescription drug purchased by such insured 622
or enrollee is included under such insured's or enrollee's health 623
insurance policy or health benefit plan, and (2) such insured or enrollee 624
purchased such prescription drug for a lower price than the average 625
amount paid by such insured or enrollee's health carrier to an in-626
network health care provider for the same prescription drug. 627
(f) The total amount credited toward any insured's or enrollee's 628
annual coinsurance, copayment, deductible or other out-of-pocket 629
expense pursuant to subsection (e) of this section shall not (1) exceed the 630
total amount that such insured or enrollee is required to pay out-of-631
pocket under the terms of the health insurance policy or health benefit 632
plan during a policy period, and (2) carry over to a new policy period. 633
This act shall take effect as follows and shall amend the following
sections:
Section 1 July 1, 2025 New section
Sec. 2 July 1, 2025 New section
Sec. 3 October 1, 2027 New section Substitute Bill No. 6870
LCO 22 of 22
Sec. 4 October 1, 2027 New section
Sec. 5 October 1, 2027 New section
Sec. 6 October 1, 2027 New section
Sec. 7 October 1, 2027 New section
Sec. 8 October 1, 2027 New section
Sec. 9 October 1, 2027 New section
Sec. 10 October 1, 2027 New section
Sec. 11 July 1, 2025 New section
Sec. 12 July 1, 2025 New section
Sec. 13 July 1, 2025 New section
Sec. 14 July 1, 2025 New section
Sec. 15 January 1, 2026 New section
Statement of Legislative Commissioners:
In Section 5, "sections 1 to 4, inclusive, and sections 6 to 10, inclusive, of"
was added for accuracy, in Section 8(a), "proceeding in accordance" was
changed to "proceeding conducted in accordance" for clarity, in Section
12(i), "such property" was changed to "such real property" for
consistency, and in Section 15(b)(1), "entity or company" was changed
to "other entity" for consistency.
INS Joint Favorable Subst. -LCO