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General Assembly Substitute Bill No. 11
January Session, 2025
AN ACT CONCERNING PRESCRIPTION DRUG ACCESS AND
AFFORDABILITY.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective July 1, 2025) For the purposes of this 1
section and sections 2 and 3 of this act: 2
(1) "Biological product" has the same meaning as provided in section 3
20-619 of the general statutes; 4
(2) "Brand-name drug" means a drug that is produced or distributed 5
in accordance with an original new drug application approved under 21 6
USC 355, as amended from time to time, but does not include an 7
authorized generic drug as defined in 42 CFR 447.502, as amended from 8
time to time; 9
(3) "Commissioner" means the Commissioner of Revenue Services; 10
(4) "Consumer price index" means the consumer price index, annual 11
average, for all urban consumers: United States city average, all items, 12
published by the United States Department of Labor, Bureau of Labor 13
Statistics, or its successor, or, if the index is discontinued, an equivalent 14
index published by a federal authority, or, if no such index is published, 15
a comparable index published by the United States Department of 16
Labor, Bureau of Labor Statistics; 17 Substitute Bill No. 11
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(5) "Generic drug" means (A) a prescription drug product that is 18
marketed or distributed in accordance with an abbreviated new drug 19
application approved under 21 USC 355, as amended from time to time, 20
(B) an authorized generic drug as defined in 42 CFR 447.502, as 21
amended from time to time, or (C) a drug that entered the market before 22
calendar year 1962 that was not originally marketed under a new 23
prescription drug product application; 24
(6) "Identified prescription drug" means (A) a brand-name drug or 25
biological product for which the patent has expired for at least twenty-26
four months, or (B) a generic drug or interchangeable biological 27
product; 28
(7) "Interchangeable biological product" has the same meaning as 29
provided in section 20-619 of the general statutes; 30
(8) "Person" has the same meaning as provided in section 12-1 of the 31
general statutes; 32
(9) "Pharmaceutical manufacturer" means a person that 33
manufactures a prescription drug and sells, directly or through another 34
person, the prescription drug for distribution in this state; 35
(10) "Prescription drug" means a legend drug, as defined in section 36
20-571 of the general statutes, approved by the federal Food and Drug 37
Administration, or any successor agency, and prescribed by a health 38
care provider to an individual in this state; 39
(11) "Reference price" means the wholesale acquisition cost, as 40
defined in 42 USC 1395w-3a, as amended from time to time, of (A) a 41
brand-name drug or biological product (i) on January 1, 2025, if the 42
patent for the brand-name drug or biological product expired on or 43
before said date, or (ii) if the patent for the brand-name drug or 44
biological product expires after January 1, 2025, on the date the patent 45
for such brand-name drug or biological product expires, or (B) a generic 46
drug or interchangeable biological product (i) on January 1, 2025, or (ii) 47
if the generic drug or interchangeable biological product is first 48 Substitute Bill No. 11
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commercially marketed in the United States after January 1, 2025, on the 49
date such generic drug or interchangeable biological product is first 50
commercially marketed in the United States; and 51
(12) "Wholesale distributor" means a person, including, but not 52
limited to, a repacker, own-label distributor, private-label distributor or 53
independent wholesale drug trader, engaged in the wholesale 54
distribution of prescription drugs. 55
Sec. 2. (NEW) (Effective July 1, 2025) (a) (1) Notwithstanding any 56
provision of the general statutes and except as provided in subdivision 57
(2) of this subsection, no pharmaceutical manufacturer or wholesale 58
distributor shall, on or after January 1, 2026, sell an identified 59
prescription drug in this state at a price that exceeds the reference price 60
for the identified prescription drug, adjusted for any increase in the 61
consumer price index. 62
(2) A pharmaceutical manufacturer or wholesale distributor may, on 63
or after January 1, 2026, sell an identified prescription drug in this state 64
at a price that exceeds the reference price for the identified prescription 65
drug, adjusted for any increase in the consumer price index, if the 66
federal Secretary of Health and Human Services determines, pursuant 67
to 21 USC 356e, as amended from time to time, that such identified 68
prescription drug is in shortage in the United States. 69
(b) (1) Except as provided in subdivision (2) of this subsection, any 70
pharmaceutical manufacturer or wholesale distributor that violates the 71
provisions of subsection (a) of this section shall be liable to this state for 72
a civil penalty. Such civil penalty shall be imposed, calculated and 73
collected on a calendar year basis by the Commissioner of Revenue 74
Services, and the amount of such civil penalty for a calendar year shall 75
be equal to eighty per cent of the difference between: 76
(A) The revenue that the pharmaceutical manufacturer or wholesale 77
distributor earned from all sales of the identified prescription drug in 78
this state during the calendar year; and 79 Substitute Bill No. 11
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(B) The revenue that the pharmaceutical manufacturer or wholesale 80
distributor would have earned from all sales of the identified 81
prescription drug in this state during the calendar year if the 82
pharmaceutical manufacturer or wholesale distributor had sold such 83
identified prescription drug at a price that did not exceed the reference 84
price for such identified prescription drug, as such reference price is 85
adjusted for any increase in the consumer price index. 86
(2) No pharmaceutical manufacturer or wholesale distributor of an 87
identified prescription drug shall be liable to this state for the civil 88
penalty imposed under subdivision (1) of this subsection unless the 89
pharmaceutical manufacturer or wholesale distributor made at least 90
two hundred fifty thousand dollars in total annual sales in this state for 91
the calendar year for which such civil penalty would otherwise be 92
imposed. 93
(c) (1) (A) For calendar years commencing on or after January 1, 2026, 94
each pharmaceutical manufacturer or wholesale distributor that 95
violated the provisions of subsection (a) of this section during any 96
calendar year shall, not later than the first day of March immediately 97
following the end of such calendar year: 98
(i) Pay to the commissioner the civil penalty imposed under 99
subsection (b) of this section for such calendar year; and 100
(ii) File with the commissioner a statement for such calendar year in 101
a form and manner, and containing all information, prescribed by the 102
commissioner. 103
(B) A pharmaceutical manufacturer or wholesale distributor that is 104
required to file the statement and pay the civil penalty pursuant to 105
subparagraph (A) of this subdivision shall electronically file such 106
statement and make such payment by electronic funds transfer in the 107
manner provided by chapter 228g of the general statutes, irrespective of 108
whether the pharmaceutical manufacturer or wholesale distributor 109
would have otherwise been required to electronically file such 110
statement or make such payment by electronic funds transfer under 111 Substitute Bill No. 11
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chapter 228g of the general statutes. 112
(2) If no statement is filed pursuant to subdivision (1) of this 113
subsection, the commissioner may make such statement at any time 114
thereafter, according to the best obtainable information and the 115
prescribed form. 116
(d) The commissioner may examine the records of any 117
pharmaceutical manufacturer or wholesale distributor that is subject to 118
the civil penalty imposed under subsection (b) of this section as the 119
commissioner deems necessary. If the commissioner determines from 120
such examination that the pharmaceutical manufacturer or wholesale 121
distributor failed to pay the full amount of such civil penalty, the 122
commissioner shall bill such pharmaceutical manufacturer or wholesale 123
distributor for the full amount of such civil penalty. 124
(e) (1) The commissioner may require each pharmaceutical 125
manufacturer or wholesale distributor that is subject to the civil penalty 126
imposed under subsection (b) of this section to keep such records as the 127
commissioner may prescribe, and produce books, papers, documents 128
and other data to provide or secure information pertinent to the 129
enforcement and collection of such civil penalty. 130
(2) The commissioner, or the commissioner's authorized 131
representative, may examine the books, papers, records and equipment 132
of any person who is subject to the provisions of this section and may 133
investigate the character of the business of such person to verify the 134
accuracy of any statement made or, if no statement is made by such 135
person, to ascertain and determine the amount of the civil penalty due 136
under subsection (b) of this section. 137
(f) Any pharmaceutical manufacturer or wholesale distributor that is 138
subject to the civil penalty imposed under subsection (b) of this section 139
and aggrieved by any action of the commissioner under subdivision (2) 140
of subsection (c) of this section or subsection (d) of this section may 141
apply to the commissioner, in writing and not later than sixty days after 142
the notice of such action is delivered or mailed to such pharmaceutical 143 Substitute Bill No. 11
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manufacturer or wholesale distributor, for a hearing, setting forth the 144
reasons why such hearing should be granted and if such pharmaceutical 145
manufacturer or wholesale distributor believes that such 146
pharmaceutical manufacturer or wholesale distributor is not liable for 147
such civil penalty or the full amount of such civil penalty, the grounds 148
for such belief and the amount by which such pharmaceutical 149
manufacturer or wholesale distributor believes such civil penalty 150
should be reduced. The commissioner shall promptly consider each 151
such application and may grant or deny the hearing requested. If the 152
hearing request is denied, the commissioner shall immediately notify 153
the pharmaceutical manufacturer or wholesale distributor. If the 154
hearing request is granted, the commissioner shall notify the 155
pharmaceutical manufacturer or wholesale distributor of the date, time 156
and place for such hearing. After such hearing, the commissioner may 157
make such order as appears just and lawful to the commissioner and 158
shall furnish a copy of such order to the pharmaceutical manufacturer 159
or wholesale distributor. The commissioner may, by notice in writing, 160
order a hearing on the commissioner's own initiative and require a 161
pharmaceutical manufacturer or wholesale distributor, or any other 162
person who the commissioner believes to be in possession of relevant 163
information concerning such pharmaceutical manufacturer or 164
wholesale distributor, to appear before the commissioner or the 165
commissioner's authorized agent with any specified books of account, 166
papers or other documents for examination under oath. 167
(g) Any pharmaceutical manufacturer or wholesale distributor that is 168
aggrieved by any order, decision, determination or disallowance of the 169
commissioner made under subsection (f) of this section may, not later 170
than thirty days after service of notice of such order, decision, 171
determination or disallowance, take an appeal therefrom to the superior 172
court for the judicial district of New Britain, which appeal shall be 173
accompanied by a citation to the commissioner to appear before said 174
court. Such citation shall be signed by the same authority and such 175
appeal shall be returnable at the same time and served and returned in 176
the same manner as is required in case of a summons in a civil action. 177 Substitute Bill No. 11
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The authority issuing the citation shall take from the appellant a bond 178
or recognizance to this state, with surety, to prosecute the appeal to 179
effect and to comply with the orders and decrees of the court. Such 180
appeals shall be preferred cases, to be heard, unless cause appears to the 181
contrary, at the first session, by the court or by a committee appointed 182
by the court. Said court may grant such relief as may be equitable and, 183
if the civil penalty was paid prior to the granting of such relief, may 184
order the Treasurer to pay the amount of such relief. If the appeal was 185
taken without probable cause, the court may tax double or triple costs, 186
as the case demands and, upon all such appeals that are denied, costs 187
may be taxed against such pharmaceutical manufacturer or wholesale 188
distributor at the discretion of the court but no costs shall be taxed 189
against this state. 190
(h) The commissioner, and any agent of the commissioner duly 191
authorized to conduct any inquiry, investigation or hearing pursuant to 192
this section, shall have power to administer oaths and take testimony 193
under oath relative to the matter of inquiry or investigation. At any 194
hearing ordered by the commissioner, the commissioner, or the 195
commissioner's agent authorized to conduct such hearing and having 196
authority by law to issue such process, may subpoena witnesses and 197
require the production of books, papers and documents pertinent to 198
such inquiry or investigation. No witness under any subpoena 199
authorized to be issued under the provisions of this section shall be 200
excused from testifying or from producing books, papers or 201
documentary evidence on the ground that such testimony or the 202
production of such books, papers or documentary evidence would tend 203
to incriminate such witness, but such books, papers or documentary 204
evidence so produced shall not be used in any criminal proceeding 205
against such witness. If any person disobeys such process or, having 206
appeared in obedience thereto, refuses to answer any pertinent question 207
put to such person by the commissioner, or the commissioner's 208
authorized agent, or to produce any books, papers or other 209
documentary evidence pursuant thereto, the commissioner, or such 210
agent, may apply to the superior court of the judicial district wherein 211 Substitute Bill No. 11
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the pharmaceutical manufacturer or wholesale distributor resides or 212
wherein the business was conducted, or to any judge of such court if the 213
same is not in session, setting forth such disobedience to process or 214
refusal to answer, and such court or such judge shall cite such person to 215
appear before such court or such judge to answer such question or to 216
produce such books, papers or other documentary evidence and, upon 217
such person's refusal to do so, shall commit such person to a community 218
correctional center until such person testifies, but not for a period longer 219
than sixty days. Notwithstanding the serving of the term of such 220
commitment by any person, the commissioner may proceed in all 221
respects with such inquiry and examination as if the witness had not 222
previously been called upon to testify. Officers who serve subpoenas 223
issued by the commissioner or under the commissioner's authority and 224
witnesses attending hearings conducted by the commissioner pursuant 225
to this section shall receive fees and compensation at the same rates as 226
officers and witnesses in the courts of this state, to be paid on vouchers 227
of the commissioner on order of the Comptroller from the proper 228
appropriation for the administration of this section. 229
(i) The amount of any civil penalty unpaid under the provisions of 230
this section may be collected under the provisions of section 12-35 of the 231
general statutes. The warrant provided under section 12-35 of the 232
general statutes shall be signed by the commissioner or the 233
commissioner's authorized agent. The amount of any such civil penalty 234
shall be a lien on the real property of the pharmaceutical manufacturer 235
or wholesale distributor from the last day of the month next preceding 236
the due date of such civil penalty until such civil penalty is paid. The 237
commissioner may record such lien in the records of any town in which 238
the real property of such pharmaceutical manufacturer or wholesale 239
distributor is situated, but no such lien shall be enforceable against a 240
bona fide purchaser or qualified encumbrancer of such real property. 241
When any civil penalty with respect to which a lien was recorded under 242
the provisions of this subsection is satisfied, the commissioner shall, 243
upon request of any interested party, issue a certificate discharging such 244
lien, which certificate shall be recorded in the same office in which such 245 Substitute Bill No. 11
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lien was recorded. Any action for the foreclosure of such lien shall be 246
brought by the Attorney General in the name of this state in the superior 247
court for the judicial district in which the real property subject to such 248
lien is situated, or, if such property is located in two or more judicial 249
districts, in the superior court for any one such judicial district, and the 250
court may limit the time for redemption or order the sale of such real 251
property or make such other or further decree as the court judges 252
equitable. The provisions of section 12-39g of the general statutes shall 253
apply to all civil penalties imposed under this section. 254
(j) (1) Any officer or employee of a pharmaceutical manufacturer or 255
wholesale distributor, who owes a duty to the pharmaceutical 256
manufacturer or wholesale distributor to pay the civil penalty imposed 257
under subsection (b) of this section on behalf of such pharmaceutical 258
manufacturer or wholesale distributor, shall file a statement with the 259
commissioner pursuant to subsection (c) of this section on behalf of such 260
pharmaceutical manufacturer or wholesale distributor and keep records 261
or supply information to the commissioner on behalf of such 262
pharmaceutical manufacturer or wholesale distributor pursuant to this 263
section. Any such officer or employee who wilfully fails, at the time 264
required under this section, to pay such civil penalty, file such 265
statement, keep such records or supply such information on behalf of 266
such pharmaceutical manufacturer or wholesale distributor shall, in 267
addition to any other penalty provided by law, be fined not more than 268
one thousand dollars or imprisoned not more than one year, or both. 269
Notwithstanding the provisions of section 54-193 of the general statutes, 270
no such officer or employee shall be prosecuted for a violation of the 271
provisions of this subdivision committed on or after January 1, 2026, 272
except within three years next after such violation is committed. 273
(2) Any officer or employee of a pharmaceutical manufacturer or 274
wholesale distributor, who owes a duty to the pharmaceutical 275
manufacturer or wholesale distributor to deliver or disclose to the 276
commissioner, or the commissioner's authorized agent, any list, 277
statement, return, account statement or other document on behalf of 278
such pharmaceutical manufacturer or wholesale distributor, and who 279 Substitute Bill No. 11
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wilfully delivers or discloses to the commissioner, or the commissioner's 280
authorized agent, any such list, statement, return, account statement or 281
other document that such officer or employee knows to be fraudulent 282
or false in any material matter shall, in addition to any other penalty 283
provided by law, be guilty of a class D felony. 284
(3) No officer or employee of a pharmaceutical manufacturer or 285
wholesale distributor shall be charged with an offense under both 286
subdivisions (1) and (2) of this subsection in relation to the same civil 287
penalty, but such officer or employee may be charged and prosecuted 288
for both such offenses upon the same information. 289
(k) Each civil penalty imposed under subsection (b) of this section 290
shall be deemed to constitute a civil fine or penalty within the meaning 291
of 42 USC 1396b(w), as amended from time to time. No portion of any 292
civil penalty imposed under subsection (b) of this section shall be 293
waived under section 12-3a of the general statutes or any other 294
applicable law. No tax credit shall be allowable against any civil penalty 295
imposed under subsection (b) of this section. 296
(l) Not later than July 1, 2027, and annually thereafter, the 297
commissioner shall prepare a list containing the name of each 298
pharmaceutical manufacturer or wholesale distributor that violated 299
subsection (a) of this section during the preceding calendar year. The 300
commissioner shall make each such list publicly available. 301
(m) The commissioner may adopt regulations, in accordance with the 302
provisions of chapter 54 of the general statutes, to implement the 303
provisions of this section. 304
Sec. 3. (NEW) (Effective July 1, 2025) (a) No pharmaceutical 305
manufacturer or wholesale distributor of an identified prescription drug 306
shall withdraw the identified prescription drug from sale in this state 307
for the purpose of avoiding the civil penalty established in subsection 308
(b) of section 2 of this act. 309
(b) Any pharmaceutical manufacturer or wholesale distributor that 310 Substitute Bill No. 11
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intends to withdraw an identified prescription drug from sale in this 311
state shall, at least one hundred eighty days before such withdrawal, 312
send advance written notice to the Office of Health Strategy disclosing 313
such pharmaceutical manufacturer's or wholesale distributor's 314
intention. 315
(c) Any pharmaceutical manufacturer or wholesale distributor that 316
violates the provisions of subsection (a) or (b) of this section shall be 317
liable to this state for a civil penalty in the amount of five hundred 318
thousand dollars. 319
Sec. 4. (NEW) (Effective July 1, 2025) (a) As used in this section and 320
sections 5 and 6 of this act, "drug purchasing agency" means The 321
University of Connecticut Health Center, the Judicial Branch and the 322
Department of Mental Health and Addiction Services, Children and 323
Families, Developmental Services or Public Health. The University of 324
Connecticut Health Center shall negotiate bulk prices for prescription 325
drugs on behalf of drug purchasing agencies with the goal of purchasing 326
such drugs at lower prices than the prices of such drugs purchased by a 327
single drug purchasing agency. 328
(b) Not later than September 1, 2025, the chief executive officer of The 329
University of Connecticut Health Center, or the chief executive officer's 330
designee, shall file a report, in accordance with the provisions of section 331
11-4a of the general statutes, with the joint standing committees of the 332
General Assembly having cognizance of matters relating to general law, 333
human services and public health on any savings realized from bulk 334
purchases of prescription drugs pursuant to subsection (a) of this 335
section. 336
Sec. 5. (NEW) (Effective July 1, 2025) (a) As used in this section, (1) 337
"maximum fair prices" means the prices negotiated by the Centers for 338
Medicare and Medicaid Services for certain prescription drugs under 339
the Inflation Reduction Act, P.L. 117-69, and (2) "drug purchasing 340
agency" has the same meaning as provided in section 4 of this act. A 341
drug purchasing agency shall incorporate by reference maximum fair 342 Substitute Bill No. 11
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prices in any negotiation with a pharmaceutical drug manufacturer to 343
supply prescription drugs for health care programs subsidized by the 344
state. 345
(b) In purchasing drugs at bulk prices pursuant to section 4 of this act 346
or maximum fair prices pursuant to this section, a drug purchasing 347
agency may enter into a compact with officials in other states to increase 348
the state's purchasing power in negotiations with pharmaceutical 349
companies. A drug purchasing agency shall consider recommendations 350
of the council established pursuant to section 6 of this act in any 351
negotiations for prescription drugs pursuant to this section or section 4 352
of this act. 353
Sec. 6. (NEW) (Effective from passage) (a) There is established a 354
Prescription Drug Affordability Council to advise the chief executive 355
officer of The University of Connecticut Health Center and drug 356
purchasing agencies on prescription drug negotiations pursuant to 357
sections 4 and 5 of this act. The council shall consist of the following 358
members: 359
(b) (1) Two appointed by the speaker of the House of Representatives, 360
one of whom represents an organization representing hospitals and one 361
of whom represents an organization representing physicians; 362
(2) Two appointed by the president pro tempore of the Senate, one of 363
whom represents an academic who has conducted research into the 364
affordability of prescription drugs and one of whom represents an 365
organization representing senior citizens in the state; 366
(3) One appointed by the majority leader of the House of 367
Representatives, who represents physicians who treat patients with rare 368
diseases; 369
(4) One appointed by the majority leader of the Senate; 370
(5) One appointed by the minority leader of the House of 371
Representatives; 372 Substitute Bill No. 11
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(6) One appointed by the minority leader of the Senate; 373
(7) The Commissioner of Health Strategy, or the commissioner's 374
designee; 375
(8) The Commissioner of Social Services, or the commissioner's 376
designee; 377
(9) The Commissioner of Consumer Protection, or the commissioner's 378
designee; 379
(10) The Insurance Commissioner, or the commissioner's designee; 380
and 381
(11) The Commissioner of Children and Families, or the 382
commissioner's designee. 383
(c) Any member of the council appointed under subdivision (1), (2), 384
(3), (4), (5) or (6) of subsection (b) of this section may be a member of the 385
General Assembly. 386
(d) All initial appointments to the council shall be made not later than 387
thirty days after the effective date of this section. Any vacancy shall be 388
filled by the appointing authority. 389
(e) The speaker of the House of Representatives and the president pro 390
tempore of the Senate shall select the chairpersons of the council from 391
among the members of the council. Such chairpersons shall schedule the 392
first meeting of the council, which shall be held not later than sixty days 393
after the effective date of this section. 394
(f) The administrative staff of the joint standing committee of the 395
General Assembly having cognizance of matters relating to human 396
services shall serve as administrative staff of the council. 397
(g) Not later than January 1, 2026, and annually thereafter, the council 398
shall submit a report on its findings and recommendations to the 399
Commissioner of Health Strategy and the joint standing committees of 400 Substitute Bill No. 11
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the General Assembly having cognizance of matters relating to general 401
law, human services and public health, in accordance with the 402
provisions of section 11-4a of the general statutes. 403
Sec. 7. Subsection (a) of section 17b-340d of the general statutes is 404
repealed and the following is substituted in lieu thereof (Effective July 1, 405
2025): 406
(a) The Commissioner of Social Services shall implement an acuity-407
based methodology for Medicaid reimbursement of nursing home 408
services effective July 1, 2022. Notwithstanding section 17b-340, for the 409
fiscal year ending June 30, 2023, and annually thereafter, the 410
Commissioner of Social Services shall establish Medicaid rates paid to 411
nursing home facilities based on cost years ending on September 412
thirtieth in accordance with the following: 413
(1) Case-mix adjustments to the direct care component, which will be 414
based on Minimum Data Set resident assessment data as well as cost 415
data reported for the cost year ending September 30, 2019, shall be made 416
effective beginning July 1, 2022, and updated every quarter thereafter. 417
After modeling such case-mix adjustments, the Commissioner of Social 418
Services shall evaluate impact on a facility by facility basis and, not later 419
than October 1, 2021, (A) make recommendations to the Secretary of the 420
Office of Policy and Management, and (B) submit a report on the 421
recommendations, in accordance with the provisions of section 11-4a, to 422
the joint standing committees of the General Assembly having 423
cognizance of matters relating to appropriations and the budgets of state 424
agencies and human services on any adjustments needed to facilitate the 425
transition to the new methodology on July 1, 2022. This evaluation may 426
include a review of inflationary allowances, case mix and budget 427
adjustment factors and stop loss and stop gain corridors and the ability 428
to make such adjustments within available appropriations. 429
(2) Beginning July 1, 2022, facilities [will be required to] shall comply 430
with collection and reporting of quality metrics as specified by the 431
Department of Social Services, after consultation with the nursing home 432 Substitute Bill No. 11
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industry, consumers, employees and the Department of Public Health. 433
Rate adjustments based on performance on quality metrics [will] shall 434
be phased in, beginning July 1, 2022, with a period of reporting only. 435
Effective July 1, 2023, the Department of Social Services shall issue 436
individualized reports annually to each nursing home facility showing 437
the impact to the Medicaid rate for such home based on the quality 438
metrics program. A nursing home facility receiving an individualized 439
quality metrics report may use such report to evaluate the impact of the 440
quality metrics program on said facility's Medicaid reimbursement. Not 441
later than June 30, 2025, the department shall submit a report, in 442
accordance with the provisions of section 11-4a, to the joint standing 443
committees of the General Assembly having cognizance of matters 444
relating to appropriations and the budgets of state agencies and human 445
services on the quality metrics program. Such report shall include 446
information regarding individualized reports and the anticipated 447
impact on nursing homes if the state were to implement a rate withhold 448
on nursing homes that fail to meet certain quality metrics. 449
(3) Geographic peer groupings of facilities shall be established by the 450
Department of Social Services pursuant to regulations adopted in 451
accordance with subsection (b) of this section. 452
(4) Allowable costs shall be divided into the following five cost 453
components: (A) Direct costs, which shall include salaries for nursing 454
personnel, related fringe benefits and costs for nursing personnel 455
supplied by a temporary nursing services agency; (B) indirect costs, 456
which shall include professional fees, dietary expenses, housekeeping 457
expenses, laundry expenses, supplies related to patient care, salaries for 458
indirect care personnel and related fringe benefits; (C) fair rent, which 459
shall be defined in regulations adopted in accordance with subsection 460
(b) of this section; (D) capital-related costs, which shall include property 461
taxes, insurance expenses, equipment leases and equipment 462
depreciation; and (E) administrative and general costs, which shall 463
include maintenance and operation of plant expenses, salaries for 464
administrative and maintenance personnel and related fringe benefits. 465
For (i) direct costs, the maximum cost shall be equal to one hundred 466 Substitute Bill No. 11
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thirty-five per cent of the median allowable cost of that peer grouping; 467
(ii) indirect costs, the maximum cost shall be equal to one hundred 468
fifteen per cent of the state-wide median allowable cost; (iii) fair rent, 469
the amount shall be calculated utilizing the amount approved pursuant 470
to section 17b-353; (iv) capital-related costs, there shall be no maximum; 471
and (v) administrative and general costs, the maximum shall be equal to 472
the state-wide median allowable cost. For purposes of this subdivision, 473
"temporary nursing services agency" and "nursing personnel" have the 474
same meaning as provided in section 19a-118. 475
(5) Costs in excess of the maximum amounts established under this 476
subsection shall not be recognized as allowable costs, except that the 477
commissioner may establish rates whereby allowable costs may exceed 478
such maximum amounts for beds which are restricted to use by patients 479
with acquired immune deficiency syndrome, traumatic brain injury or 480
other specialized services. 481
(6) On or after June 30, 2022, the commissioner may, in the 482
commissioner's discretion and within available appropriations, provide 483
pro rata fair rent increases to facilities which have documented fair rent 484
additions placed in service in the most recently filed cost report that are 485
not otherwise included in the rates issued. The commissioner may 486
provide, within available appropriations, pro rata fair rent increases, 487
which may, at the discretion of the commissioner, include increases for 488
facilities which have undergone a material change in circumstances 489
related to fair rent additions in the most recently filed cost report. The 490
commissioner may allow minimum fair rent as the basis upon which 491
reimbursement associated with improvements to real property is 492
added. 493
(7) For the purpose of determining allowable fair rent, a facility with 494
allowable fair rent less than the twenty-fifth percentile of the state-wide 495
allowable fair rent shall be reimbursed as having allowable fair rent 496
equal to the twenty-fifth percentile of the state-wide allowable fair rent. 497
Any facility with a rate of return on real property other than land in 498
excess of eleven per cent shall have such allowance revised to eleven per 499 Substitute Bill No. 11
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cent. Any facility or its related realty affiliate which finances or 500
refinances debt through bonds issued by the Connecticut Health and 501
Education Facilities Authority shall report the terms and conditions of 502
such financing or refinancing to the Commissioner of Social Services not 503
later than thirty days after completing such financing or refinancing. 504
The commissioner may revise the facility's fair rent component of its rate 505
to reflect any financial benefit the facility or its related realty affiliate 506
received as a result of such financing or refinancing. The commissioner 507
shall determine allowable fair rent for real property other than land 508
based on the rate of return for the cost year in which such bonds were 509
issued. The financial benefit resulting from a facility financing or 510
refinancing debt through such bonds shall be shared between the state 511
and the facility to an extent determined by the commissioner on a case-512
by-case basis and shall be reflected in an adjustment to the facility's 513
allowable fair rent. 514
(8) A facility shall receive cost efficiency adjustments for indirect costs 515
and for administrative and general costs if such costs are below the 516
state-wide median costs. The cost efficiency adjustments shall equal 517
twenty-five per cent of the difference between allowable reported costs 518
and the applicable median allowable cost established pursuant to 519
subdivision (4) of this subsection. 520
(9) On and after July 1, 2025, costs shall be rebased no more frequently 521
than every two years and no less frequently than every four years, as 522
determined by the commissioner. There shall be no inflation adjustment 523
during a year in which a facility's rates are rebased. The commissioner 524
shall determine whether and to what extent a change in ownership of a 525
facility shall occasion the rebasing of the facility's costs. 526
(10) The method of establishing rates for new facilities shall be 527
determined by the commissioner in accordance with the provisions of 528
this subsection. 529
(11) There shall be no increase to rates based on inflation or any 530
inflationary factor for the fiscal years ending June 30, 2022, and June 30, 531 Substitute Bill No. 11
LCO 5928 18 of 52
2023, unless otherwise authorized under subdivision (1) of this 532
subsection. Notwithstanding section 17-311-52 of the regulations of 533
Connecticut state agencies, for the fiscal years ending June 30, 2024, and 534
June 30, 2025, there shall be no inflationary increases to rates beyond 535
those already factored into the model for the transition to an acuity-536
based reimbursement system. Notwithstanding any other provisions of 537
this chapter, any subsequent increase to allowable operating costs, 538
excluding fair rent, shall be inflated by the gross domestic product 539
deflator when funding is specifically appropriated for such purposes in 540
the enacted budget. The rate of inflation shall be computed by 541
comparing the most recent rate year to the average of the gross domestic 542
product deflator for the previous four fiscal quarters ending March 543
thirty-first. Any increase to rates based on inflation shall be applied 544
prior to the application of any other budget adjustment factors that may 545
impact such rates. 546
(12) For the fiscal year beginning July 1, 2025, and each fiscal year 547
thereafter, the commissioner shall require a nursing home facility to 548
spend not less than eighty per cent of funding received from Medicaid, 549
Medicare and all other payment sources on direct care of residents, 550
provided the commissioner may adjust the percentage spent on direct 551
care for a nursing home facility with a capital improvement project or a 552
fair rent increase approved by the commissioner. For the fiscal year 553
beginning July 1, 2027, and each fiscal year thereafter, the commissioner 554
may decrease rates of Medicaid reimbursement for any nursing home 555
that does not comply with the provisions of this subdivision. For 556
purposes of this subdivision, (A) "direct care" means hands-on care 557
provided to a facility resident by nursing personnel, including, but not 558
limited to, assistance with feeding, bathing, toileting, dressing, lifting or 559
moving residents, medication administration and salary, fringe benefits 560
and supplies related to direct care; and (B) "nursing personnel" means 561
an advanced practice registered nurse, licensed pursuant to chapter 378, 562
a registered nurse or practical nurse, licensed pursuant to chapter 378, 563
or a nurse's aide, registered pursuant to chapter 378a. 564
[(12)] (13) For purposes of computing minimum allowable patient 565 Substitute Bill No. 11
LCO 5928 19 of 52
days, utilization of a facility's certified beds shall be determined at a 566
minimum of ninety per cent of capacity, except for facilities that have 567
undergone a change in ownership, new facilities, and facilities which 568
are certified for additional beds which may be permitted a lower 569
occupancy rate for the first three months of operation after the effective 570
date of licensure. 571
[(13)] (14) Rates determined under this section shall comply with 572
federal laws and regulations. 573
[(14)] (15) The Commissioner of Social Services may authorize an 574
interim rate for a facility demonstrating circumstances particular to that 575
individual facility impacting facility finances or costs not reflected in the 576
underlying rates. 577
Sec. 8. (NEW) (Effective July 1, 2025) (a) As used in this section, (1) 578
"emergency medical condition" means a medical condition, including 579
emergency labor and delivery, manifesting itself by acute symptoms of 580
sufficient severity, including severe pain, such that the absence of 581
immediate medical attention could reasonably be expected to result in 582
(A) placing the patient's health in serious jeopardy, (B) serious 583
impairment to bodily functions, or (C) serious dysfunction of any bodily 584
organ or part; and (2) "emergency Medicaid coverage" means Medicaid 585
coverage for treatment of an emergency medical condition. 586
(b) The Commissioner of Social Services shall expand emergency 587
Medicaid coverage consistent with federal law for treatment of 588
emergency medical conditions, including, but not limited to, emergency 589
medical conditions related to (1) a high-risk pregnancy, (2) diabetes type 590
1 in persons under the age of twenty-one, (3) diabetic emergencies, 591
including, but not limited to, diabetic ketoacidosis, (4) renal failure 592
requiring ongoing dialysis, (5) fracture of a bone in the skull, arm, neck, 593
leg, spine or pelvis occurring in the two-month period prior to a request 594
for emergency Medicaid coverage, (6) hypertensive emergencies 595
involving persons presenting with signs or symptoms of end organ 596
damage and systolic blood pressure equaling or exceeding one hundred 597 Substitute Bill No. 11
LCO 5928 20 of 52
eighty or diastolic blood pressure equaling or exceeding one hundred 598
twenty, (7) unstable seizure disorder characterized by at least five 599
minutes of uncontrollable seizures or at least two discrete seizures 600
between which the person does not regain consciousness, (8) active 601
treatment for cancer related to a current diagnosis, (9) ventilator 602
dependency, (10) labor and delivery, and (11) acute inpatient or 603
outpatient psychiatric treatment. 604
(c) Not later than July 1, 2026, the commissioner shall establish an 605
administrative system for persons to apply in advance for emergency 606
Medicaid coverage for emergency medical conditions that can be 607
treated in outpatient settings rather than in hospital emergency 608
departments. The commissioner shall include a prominent link to the 609
application and a list of covered emergency medical conditions on the 610
Internet web site of the Department of Social Services. The 611
commissioner shall also include information about advance 612
applications for emergency Medicaid coverage and a list of covered 613
emergency medical conditions in department forms and policy 614
manuals. 615
Sec. 9. (NEW) (Effective July 1, 2025) (a) The Commissioner of Social 616
Services shall increase and then eliminate the asset limit for the HUSKY 617
C health program, as defined in section 17b-290 of the general statutes, 618
over a five-year period in accordance with the provisions of this section: 619
(1) For the fiscal year ending June 30, 2026, the commissioner shall 620
increase the asset limit for (A) an unmarried person from one thousand 621
six hundred dollars to ten thousand dollars, and (B) married persons 622
from two thousand four hundred dollars to fifteen thousand dollars; 623
(2) For the fiscal year ending June 30, 2027, the commissioner shall 624
increase the asset limit for (A) an unmarried person to twenty-five 625
thousand dollars, and (B) married persons to forty thousand dollars; 626
(3) For the fiscal year ending June 30, 2028, the commissioner shall 627
increase the asset limit for (A) an unmarried person to seventy-five 628
thousand dollars, and (B) married persons to one hundred thousand 629 Substitute Bill No. 11
LCO 5928 21 of 52
dollars; 630
(4) For the fiscal year ending June 30, 2029, the commissioner shall 631
increase the asset limit for (A) an unmarried person to one hundred 632
thousand dollars, and (B) married persons to one hundred fifty 633
thousand dollars; and 634
(5) For the fiscal year ending June 30, 2030, and each fiscal year 635
thereafter, there shall be no asset limit for unmarried or married 636
persons. 637
(b) The Commissioner of Social Services shall allow any person, 638
whose income exceeds the income limits for the HUSKY C health 639
program but who otherwise qualifies, to qualify for the program by 640
spending down such person's excess income over the program income 641
limits on incurred medical bills in accordance with 42 CFR 435.831. 642
(c) Not later than July 1, 2026, and annually thereafter until July 1, 643
2030, the commissioner shall file a report, in accordance with the 644
provisions of section 11-4a of the general statutes, with the joint 645
standing committees of the General Assembly having cognizance of 646
matters relating to appropriations and the budgets of state agencies and 647
human services on (1) the number of persons eligible for the HUSKY C 648
health program for the prior fiscal year, and (2) any increased costs 649
incurred by the state that are attributable to changes in the asset limits. 650
Sec. 10. (NEW) (Effective January 1, 2026) (a) As used in this section: 651
(1) "General anesthesia" has the same meaning as provided in section 652
20-123a of the general statutes; and 653
(2) "Medical necessity" has the same meaning as provided in section 654
38a-482a of the general statutes. 655
(b) No individual health insurance policy providing coverage of the 656
type specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 657
of the general statutes delivered, issued for delivery, renewed, amended 658
or continued in this state on or after January 1, 2026, shall (1) if such 659 Substitute Bill No. 11
LCO 5928 22 of 52
policy provides coverage for general anesthesia, (A) impose an arbitrary 660
time limit on reimbursement for general anesthesia provided during 661
any medically necessary procedure, or (B) deny, reduce, terminate or 662
fail to provide such reimbursement, in whole or in part, for general 663
anesthesia solely because the duration of care exceeded a predetermined 664
time limit as determined by the insurer, or (2) impose unilateral 665
arbitrary limitations on reimbursement for medically necessary 666
ancillary services. 667
(c) The medical necessity for administering general anesthesia during 668
any medical procedure shall be determined by the attending board-669
certified anesthesiologist during such medical procedure. 670
Sec. 11. (NEW) (Effective January 1, 2026) (a) As used in this section: 671
(1) "General anesthesia" has the same meaning as provided in section 672
20-123a of the general statutes; and 673
(2) "Medical necessity" has the same meaning as provided in section 674
38a-482a of the general statutes. 675
(b) No group health insurance policy providing coverage of the type 676
specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 of 677
the general statutes delivered, issued for delivery, renewed, amended 678
or continued in this state on or after January 1, 2026, shall (1) if such 679
policy provides coverage for general anesthesia, (A) impose an arbitrary 680
time limit on reimbursement for general anesthesia provided during 681
any medically necessary procedure, or (B) deny, reduce, terminate or 682
fail to provide such reimbursement, in whole or in part, for general 683
anesthesia solely because the duration of care exceeded a predetermined 684
time limit as determined by the insurer, or (2) impose unilateral 685
arbitrary limitations on reimbursement for medically necessary 686
ancillary services. 687
(c) The medical necessity for administering general anesthesia during 688
any medical procedure shall be determined by the attending board-689
certified anesthesiologist during such medical procedure. 690 Substitute Bill No. 11
LCO 5928 23 of 52
Sec. 12. (NEW) (Effective January 1, 2026) Any stop loss insurance 691
policy used in conjunction with a self-funded employee health benefit 692
plan shall: (1) Provide coverage for (A) essential health benefits as 693
defined in the Patient Protection and Affordable Care Act, P.L. 111-148, 694
and regulations adopted thereunder, and (B) the group state-mandated 695
coverage requirements under chapter 700c of the general statutes; or (2) 696
have (A) a minimum individual attachment point of not less than 697
seventy-five thousand dollars, and (B) an aggregate attachment point of 698
not less than two hundred fifty thousand dollars. 699
Sec. 13. (NEW) (Effective from passage) (a) Not later than thirty days 700
after the effective date of this section, the Commissioner of Social 701
Services shall petition the Secretary of the Department of Health and 702
Human Services pursuant to 28 USC 1498, as amended from time to 703
time, to authorize generic, lower cost forms of glucagon-like peptide 704
(GLP-1) prescription drugs approved by the federal Food and Drug 705
Administration to treat obesity or diabetes. 706
(b) Upon approval of such petition, the commissioner shall enter into 707
a contract with any manufacturer of generic forms of such drugs 708
approved by the federal Food and Drug Administration to supply such 709
drugs to the state for use by HUSKY Health program members. The 710
commissioner may enter into a consortium with officials in other states 711
in contracting with such manufacturer for such drugs. 712
(c) The commissioner shall develop a strategic plan to maximize 713
access to and minimize the cost of such drugs and, not later than 714
December 31, 2025, submit a report, in accordance with the provisions 715
of section 11-4a of the general statutes, on the plan to the joint standing 716
committee of the General Assembly having cognizance of matters 717
relating to human services and to the advisory committee established 718
pursuant to section 14 of this act. 719
Sec. 14. (Effective from passage) (a) There is established an advisory 720
committee to (1) study ways to maximize access to cost-effective 721
prescription drugs approved by the federal Food and Drug 722 Substitute Bill No. 11
LCO 5928 24 of 52
Administration for the treatment of obesity, and (2) make 723
recommendations concerning implementation of the strategic plan 724
developed pursuant to section 13 of this act to the Commissioner of 725
Social Services. 726
(b) The committee shall consist of the following members: 727
(1) Two patient advocates appointed by the chairperson of the 728
Council on Medical Assistance Program Oversight, established 729
pursuant to section 17b-28 of the general statutes; 730
(2) Two pharmacists enrolled as Medicaid providers, appointed by 731
the Commissioner of Social Services; and 732
(3) Two medical professionals, including at least one doctor certified 733
by the American Board of Obesity Medicine, appointed by the Senate 734
and House chairpersons of the joint standing committee of the General 735
Assembly having cognizance of matters relating to human services. 736
(c) The committee shall be appointed and convene not later than 737
thirty days after the effective date of this section and choose a 738
chairperson. The committee shall meet at least bimonthly. 739
(d) The committee shall review the strategic plan developed by the 740
Commissioner of Social Services pursuant to section 13 of this act and 741
shall make recommendations to the commissioner on implementation 742
of the plan and the results of its study not later than January 31, 2026. 743
The committee shall terminate upon submission of its recommendations 744
to the commissioner or January 31, 2026, whichever is later. 745
Sec. 15. Section 17b-278l of the general statutes is repealed and the 746
following is substituted in lieu thereof (Effective July 1, 2025): 747
(a) (1) As used in this section, "bariatric surgery" means surgical 748
changes to the digestive system to help a patient with obesity to lose 749
weight; 750
(2) "Body mass index", or "BMI", means the number calculated by 751 Substitute Bill No. 11
LCO 5928 25 of 52
dividing an individual's weight in kilograms by the individual's height 752
in meters squared; 753
(3) "Medical services" means (A) prescription drugs approved by the 754
federal Food and Drug Administration for the treatment of obesity on 755
an outpatient basis, and (B) nutritional counseling provided by a 756
registered dietitian-nutritionist certified pursuant to section 20-206n; 757
(4) "Severe obesity" means a body mass index that is: 758
(A) Greater than forty; or 759
(B) Thirty-five or more if an individual has been diagnosed with a 760
comorbid disease or condition, including, but not limited to, a 761
cardiopulmonary condition, diabetes, hypertension or sleep apnea; 762
[and] 763
(5) "Obesity" means a body mass index of thirty or higher; and 764
(6) "Weight loss drugs" means glucagon-like peptide 1 (GLP-1) 765
prescription drugs approved by the federal Food and Drug 766
Administration for weight loss or commonly used for weight loss, sleep 767
apnea or to reduce risks of cardiovascular disease. 768
(b) The Commissioner of Social Services shall provide medical 769
assistance for (1) bariatric surgery and related medical services for 770
Medicaid and HUSKY B beneficiaries with severe obesity, and (2) 771
medical services for Medicaid and HUSKY B beneficiaries with a body 772
mass index greater than thirty-five, [provided such beneficiaries 773
otherwise meet conditions set by the Centers for Medicare and Medicaid 774
Services for such surgery and medical services] including weight loss 775
drugs. The commissioner shall continue to provide Medicaid coverage 776
for beneficiaries treated with weight loss drugs if their BMI drops below 777
thirty-five and a licensed physician certifies, in writing, that their BMI 778
would increase above thirty-five if such drugs were discontinued. If 779
necessary, the commissioner may amend the Medicaid state plan and 780
the state plan for the Children's Health Insurance Program to implement 781 Substitute Bill No. 11
LCO 5928 26 of 52
the provisions of this section. 782
Sec. 16. Section 38a-479ttt of the general statutes is repealed and the 783
following is substituted in lieu thereof (Effective October 1, 2025): 784
Not later than March 1, 2021, and annually thereafter, the 785
commissioner shall prepare a report, for the immediately preceding 786
calendar year, describing the rebate practices of health carriers. The 787
report shall contain (1) an explanation of the manner in which health 788
carriers accounted for rebates in calculating premiums for health care 789
plans delivered, issued for delivery, renewed, amended or continued 790
during such year, (2) a statement disclosing whether, and describing the 791
manner in which, health carriers made rebates available to insureds at 792
the point of purchase during such year, (3) any other manner in which 793
health carriers applied rebates during such year, (4) the percentage of 794
rebate dollars used by health carriers to reduce cost-sharing 795
requirements during such year, (5) an evaluation of rebate practices to 796
reduce cost-sharing for health care plans delivered, issued for delivery, 797
renewed, amended or continued during such year, and [(4)] (6) such 798
other information as the commissioner, in the commissioner's 799
discretion, deems relevant for the purposes of this section. The 800
commissioner shall publish a copy of the report on the department's 801
Internet web site. 802
Sec. 17. (NEW) (Effective from passage) As used in this section and 803
section 18 of this act: 804
(1) "340B drug" means a drug that (A) is a covered outpatient drug 805
within the meaning of 42 USC 256b; (B) has been subject to any offer for 806
reduced prices by a manufacturer under 42 USC 256b(a)(1); and (C) is 807
purchased by a covered entity. "340B drug" includes a drug that would 808
have been purchased but for the restriction or limitation described in 809
subsection (a) of section 18 of this act; 810
(2) "Biologic" has the same meaning as provided in section 21a-70d of 811
the general statutes; 812 Substitute Bill No. 11
LCO 5928 27 of 52
(3) "Covered entity" means The University of Connecticut Health 813
Center, a federally qualified health center, a family planning clinic and 814
a Ryan White clinic; 815
(4) "Manufacturer" has the same meaning as provided in section 21a-816
70 of the general statutes, except that such definition shall include 817
manufacturers of biologics; 818
(5) "Package" has the same meaning as provided in 21 USC 819
360eee(11)(A); and 820
(6) "Pharmacy" has the same meaning as provided in section 20-571 821
of the general statutes. 822
Sec. 18. (NEW) (Effective from passage) (a) A manufacturer, or an agent 823
or affiliate of such manufacturer, shall not, either directly or indirectly: 824
(1) Deny, restrict, prohibit, discriminate against or otherwise limit the 825
acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy 826
that is under contract with, or otherwise authorized by, a covered entity 827
to receive 340B drugs on behalf of the covered entity unless such receipt 828
is prohibited under federal law; or 829
(2) Require a covered entity, or a pharmacy that is under contract 830
with a covered entity, to submit any claims or utilization data as a 831
condition for allowing the acquisition of a 340B drug by, or delivery of 832
a 340B drug to, a covered entity, or a pharmacy that is under contract 833
with a covered entity, unless the claims or utilization data sharing is 834
required by the United States Department of Health and Human 835
Services. 836
(b) (1) On and after July 1, 2025, if the Commissioner of Consumer 837
Protection receives information and has a reasonable belief, after 838
evaluating such information, that any manufacturer, or an agent or 839
affiliate of such manufacturer, has acted in violation of any provision of 840
this section or regulation adopted thereunder, such manufacturer, or an 841
agent or affiliate of such manufacturer, shall be subject to a civil penalty 842 Substitute Bill No. 11
LCO 5928 28 of 52
of not more than fifty thousand dollars for each violation. The 843
commissioner shall issue a notice of violation and civil penalty and may 844
issue such notice by first-class mail or personal service. Such notice shall 845
include: (A) A reference to the section of the general statutes or 846
regulation of Connecticut state agencies believed or alleged to have been 847
violated; (B) a short and plain-language statement of the matters 848
asserted or charged; (C) a description of the activity to cease; (D) a 849
statement of the amount of the civil penalty or penalties that may be 850
imposed; (E) a statement concerning the right to a hearing; and (F) a 851
statement that such manufacturer, or an agent or affiliate of such 852
manufacturer, may, not later than ten business days after receipt of such 853
notice, make a request for a hearing on the matters asserted. 854
(2) The manufacturer, or an agent or affiliate of such manufacturer, 855
to whom such notice is provided pursuant to subparagraph (A) of 856
subdivision (1) of this subsection may, not later than ten business days 857
after receipt of such notice, make written application to the Department 858
of Consumer Protection to request a hearing to demonstrate that such 859
violation did not occur. The failure to make a timely request for a 860
hearing shall result in the issuance of a cease and desist order or 861
imposition of a civil penalty by the department. All hearings held under 862
this subsection shall be conducted in accordance with the provisions for 863
contested cases under chapter 54 of the general statutes. 864
(3) Following any hearing before the Department of Consumer 865
Protection pursuant to subdivision (2) of this subsection, if the 866
department finds, by a preponderance of the evidence, that any 867
manufacturer, or an agent or affiliate of such manufacturer, violated or 868
is violating any provision of this subsection, any regulation adopted 869
thereunder or any order issued by the department, the department shall 870
issue a final cease and desist order in addition to any civil penalty the 871
department imposes. 872
(c) Nothing in this section shall be construed or applied to be in 873
conflict with or less restrictive than: 874 Substitute Bill No. 11
LCO 5928 29 of 52
(1) Applicable federal law and related regulations, including 21 USC 875
355-1, as amended from time to time; or 876
(2) Other laws of this state to the extent such laws are compatible with 877
applicable federal law. 878
(d) The Commissioner of Consumer Protection shall adopt 879
regulations in accordance with the provisions of chapter 54 of the 880
general statutes to implement the provisions of this section. 881
Sec. 19. (NEW) (Effective July 1, 2025) (a) As used in this section, "pay 882
to delay" means an agreement between a pharmaceutical manufacturer 883
and a competitor to delay the launch of a generic drug based on an 884
expiring or expired patent for a drug made by the pharmaceutical 885
manufacturer. 886
(b) A pharmaceutical manufacturer doing business in this state shall 887
annually report to the Commissioner of Consumer Protection any "pay 888
to delay" agreements such manufacturer has with any competitor and 889
the prescription drugs included in such agreement. A pharmaceutical 890
manufacturer shall make such reports in a form and manner prescribed 891
by the commissioner. 892
(c) The commissioner shall adopt regulations, in accordance with the 893
provisions of chapter 54 of the general statutes, to implement the 894
provisions of this section and may establish penalties and an 895
administrative hearing process in accordance with chapter 54 of the 896
general statutes for a pharmaceutical manufacturer that violates the 897
provisions of this section. 898
Sec. 20. (NEW) (Effective January 1, 2026) (a) As used in this section: 899
(1) "Health benefit plan" has the same meaning as provided in section 900
38a-472f of the general statutes; 901
(2) "Insulin" means an insulin product, including, but not limited to, 902
an insulin pen or vial, that is licensed under 42 USC 262(a) or 42 USC 903
262(k), as amended from time to time; 904 Substitute Bill No. 11
LCO 5928 30 of 52
(3) "Eligible insulin product" means an insulin product for which at 905
least two licenses have been issued and continues to be marketed 906
pursuant to such licensure; 907
(4) "Net cost" means the cost of an insulin product taking into account 908
rebates or discounts for that specific product, excluding (A) rebates or 909
discounts required by state or federal law, including Medicaid, 910
Medicare and Section 340B of the Public Health Service Act, 42 USC 911
256b, as amended from time to time, and (B) rebates or discounts related 912
to portfolio agreements that relate to purchase of multiple insulin 913
products or other drugs; 914
(5) "State entity" means any state agency, or any person acting on 915
behalf of the state, that purchases a prescription drug for an individual 916
with health insurance paid for by the state, including health insurance 917
offered by local, state or federal agencies, or through organizations 918
licensed in the state; 919
(6) "Wholesale acquisition cost" means the price of a medication set 920
by a pharmaceutical manufacturer in the United States when selling to 921
a wholesaler; and 922
(7) "Wholesaler" means a wholesaler, as defined in section 21a-70 of 923
the general statutes, that has received a certificate of registration from 924
the Commissioner of Consumer Protection pursuant to said section. 925
(b) A state entity and health benefit plan shall, except as otherwise 926
required in any collective bargaining agreement affecting the state 927
employee health plan established pursuant to section 5-259 of the 928
general statutes, make available in a preferred tier with no copayment 929
or out-of-pocket cost an eligible insulin product at the lowest wholesale 930
acquisition cost to a beneficiary. Notwithstanding the provisions of this 931
section, if a state entity or health benefit plan determines that another 932
eligible insulin product has a lower net cost than the lowest wholesale 933
acquisition cost, such entity or health plan may offer that product with 934
no out-of-pocket payment to a beneficiary of such state entity or health 935
benefit plan. Nothing in this section shall prevent such entity or health 936 Substitute Bill No. 11
LCO 5928 31 of 52
benefit plan from covering more than one eligible insulin product in a 937
preferred tier with no copayment or out-of-pocket cost to a beneficiary 938
of such entity or health benefit plan. 939
Sec. 21. Section 38a-492d of the general statutes is repealed and the 940
following is substituted in lieu thereof (Effective January 1, 2026): 941
(a) For the purposes of this section: 942
(1) "Diabetes device" has the same meaning as provided in section 20-943
616; 944
(2) "Diabetic ketoacidosis device" has the same meaning as provided 945
in section 20-616; 946
(3) "Glucagon drug" has the same meaning as provided in section 20-947
616; 948
(4) "High deductible health plan" has the same meaning as that term 949
is used in subsection (f) of section 38a-493; 950
(5) "Insulin drug" has the same meaning as provided in section 20-951
616; 952
(6) "Noninsulin drug" means a drug, including, but not limited to, a 953
glucagon drug, glucose tablet or glucose gel, that does not contain 954
insulin and is approved by the federal Food and Drug Administration 955
to treat diabetes; and 956
(7) "Prescribing practitioner" has the same meaning as provided in 957
section 20-571. 958
(b) Notwithstanding the provisions of section 38a-492a, each 959
individual health insurance policy providing coverage of the type 960
specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 961
delivered, issued for delivery, renewed, amended or continued in this 962
state shall provide coverage for the treatment of all types of diabetes. 963
Such coverage shall include, but need not be limited to, coverage for 964 Substitute Bill No. 11
LCO 5928 32 of 52
medically necessary: 965
(1) Laboratory and diagnostic testing and screening, including, but 966
not limited to, hemoglobin A1c testing and retinopathy screening, for 967
all types of diabetes; 968
(2) Insulin drugs (A) prescribed by a prescribing practitioner, or (B) 969
prescribed and dispensed pursuant to subsection (d) of section 20-616 970
once during a policy year; 971
(3) Noninsulin drugs (A) prescribed by a prescribing practitioner, or 972
(B) prescribed and dispensed pursuant to subsection (d) of section 20-973
616 once during a policy year if the noninsulin drug is a glucagon drug; 974
(4) Diabetes devices in accordance with the insured's diabetes 975
treatment plan, including, but not limited to, diabetes devices 976
prescribed and dispensed pursuant to subsection (d) of section 20-616 977
once during a policy year; and 978
(5) Diabetic ketoacidosis devices in accordance with the insured's 979
diabetes treatment plan, including, but not limited to, diabetic 980
ketoacidosis devices prescribed and dispensed pursuant to subsection 981
(d) of section 20-616 once during a policy year. 982
(c) Notwithstanding the provisions of section 38a-492a, no policy 983
described in subsection (b) of this section shall impose coinsurance, 984
copayments, deductibles and other out-of-pocket expenses on an 985
insured that exceed: 986
(1) Twenty-five dollars for each thirty-day supply of a medically 987
necessary covered insulin drug (A) prescribed to the insured by a 988
prescribing practitioner, or (B) prescribed and dispensed pursuant to 989
subsection (d) of section 20-616 once during a policy year; 990
(2) Twenty-five dollars for each thirty-day supply of a medically 991
necessary covered noninsulin drug (A) prescribed to the insured by a 992
prescribing practitioner, or (B) prescribed and dispensed pursuant to 993
subsection (d) of section 20-616 once during a policy year if such 994 Substitute Bill No. 11
LCO 5928 33 of 52
noninsulin drug is a glucagon drug; 995
(3) One hundred dollars for a thirty-day supply of all medically 996
necessary covered diabetes devices and diabetic ketoacidosis devices for 997
such insured that are in accordance with such insured's diabetes 998
treatment plan, including, but not limited to, diabetes devices and 999
diabetic ketoacidosis devices prescribed and dispensed pursuant to 1000
subsection (d) of section 20-616 once during a policy year. 1001
(d) Notwithstanding the provisions of subsection (c) of this section 1002
and section 38a-492a, on and after January 1, 2026, any policy described 1003
in subsection (b) of this section shall make available in a preferred tier 1004
with no copayment or out-of-pocket cost an eligible insulin product, as 1005
defined in section 20 of this act, at the lowest wholesale acquisition cost 1006
in accordance with section 20 of this act. 1007
[(d)] (e) The provisions of [subsection (c)] subsections (c) and (d) of 1008
this section shall apply to a high deductible health plan to the maximum 1009
extent permitted by federal law, except if such plan is used to establish 1010
a medical savings account or an Archer MSA pursuant to Section 220 of 1011
the Internal Revenue Code of 1986, or any subsequent corresponding 1012
internal revenue code of the United States, as amended from time to 1013
time, or a health savings account pursuant to Section 223 of said Internal 1014
Revenue Code, as amended from time to time, the provisions of said 1015
[subsection (c)] subsections shall apply to such plan to the maximum 1016
extent that (1) is permitted by federal law, and (2) does not disqualify 1017
such account for the deduction allowed under said Section 220 or 223, 1018
as applicable. 1019
Sec. 22. Section 38a-518d of the general statutes is repealed and the 1020
following is substituted in lieu thereof (Effective January 1, 2026): 1021
(a) For the purposes of this section: 1022
(1) "Diabetes device" has the same meaning as provided in section 20-1023
616; 1024 Substitute Bill No. 11
LCO 5928 34 of 52
(2) "Diabetic ketoacidosis device" has the same meaning as provided 1025
in section 20-616; 1026
(3) "Glucagon drug" has the same meaning as provided in section 20-1027
616; 1028
(4) "High deductible health plan" has the same meaning as that term 1029
is used in subsection (f) of section 38a-520; 1030
(5) "Insulin drug" has the same meaning as provided in section 20-1031
616; 1032
(6) "Noninsulin drug" means a drug, including, but not limited to, a 1033
glucagon drug, glucose tablet or glucose gel, that does not contain 1034
insulin and is approved by the federal Food and Drug Administration 1035
to treat diabetes; and 1036
(7) "Prescribing practitioner" has the same meaning as provided in 1037
section 20-571. 1038
(b) Notwithstanding the provisions of section 38a-518a, each group 1039
health insurance policy providing coverage of the type specified in 1040
subdivisions (1), (2), (4), (11) and (12) of section 38a-469 delivered, 1041
issued for delivery, renewed, amended or continued in this state shall 1042
provide coverage for the treatment of all types of diabetes. Such 1043
coverage shall include, but need not be limited to, coverage for 1044
medically necessary: 1045
(1) Laboratory and diagnostic testing and screening, including, but 1046
not limited to, hemoglobin A1c testing and retinopathy screening, for 1047
all types of diabetes; 1048
(2) Insulin drugs (A) prescribed by a prescribing practitioner, or (B) 1049
prescribed and dispensed pursuant to subsection (d) of section 20-616 1050
once during a policy year; 1051
(3) Noninsulin drugs (A) prescribed by a prescribing practitioner, or 1052
(B) prescribed and dispensed pursuant to subsection (d) of section 20-1053 Substitute Bill No. 11
LCO 5928 35 of 52
616 once during a policy year if the noninsulin drug is a glucagon drug; 1054
(4) Diabetes devices in accordance with the insured's diabetes 1055
treatment plan, including, but not limited to, diabetes devices 1056
prescribed and dispensed pursuant to subsection (d) of section 20-616 1057
once during a policy year; and 1058
(5) Diabetic ketoacidosis devices in accordance with the insured's 1059
diabetes treatment plan, including, but not limited to, diabetic 1060
ketoacidosis devices prescribed and dispensed pursuant to subsection 1061
(d) of section 20-616 once during a policy year. 1062
(c) Notwithstanding the provisions of section 38a-518a, no policy 1063
described in subsection (b) of this section shall impose coinsurance, 1064
copayments, deductibles and other out-of-pocket expenses on an 1065
insured that exceed: 1066
(1) Twenty-five dollars for each thirty-day supply of a medically 1067
necessary covered insulin drug (A) prescribed to the insured by a 1068
prescribing practitioner, or (B) prescribed and dispensed pursuant to 1069
subsection (d) of section 20-616 once during a policy year; 1070
(2) Twenty-five dollars for each thirty-day supply of a medically 1071
necessary covered noninsulin drug (A) prescribed to the insured by a 1072
prescribing practitioner, or (B) prescribed and dispensed pursuant to 1073
subsection (d) of section 20-616 once during a policy year if such 1074
noninsulin drug is a glucagon drug; 1075
(3) One hundred dollars for a thirty-day supply of all medically 1076
necessary covered diabetes devices and diabetic ketoacidosis devices for 1077
such insured that are in accordance with such insured's diabetes 1078
treatment plan, including, but not limited to, diabetes devices and 1079
diabetic ketoacidosis devices prescribed and dispensed pursuant to 1080
subsection (d) of section 20-616 once during a policy year. 1081
(d) Notwithstanding the provisions of subsection (c) of this section 1082
and section 38a-518a, on and after January 1, 2026, any policy described 1083 Substitute Bill No. 11
LCO 5928 36 of 52
in subsection (b) of this section shall make available in a preferred tier 1084
with no copayment or out-of-pocket cost an eligible insulin product, as 1085
defined in section 20 of this act, at the lowest wholesale acquisition cost 1086
in accordance with section 20 of this act. 1087
[(d)] (e) The provisions of [subsection (c)] subsections (c) and (d) of 1088
this section shall apply to a high deductible health plan to the maximum 1089
extent permitted by federal law, except if such plan is used to establish 1090
a medical savings account or an Archer MSA pursuant to Section 220 of 1091
the Internal Revenue Code of 1986, or any subsequent corresponding 1092
internal revenue code of the United States, as amended from time to 1093
time, or a health savings account pursuant to Section 223 of said Internal 1094
Revenue Code, as amended from time to time, the provisions of said 1095
[subsection (c)] subsections shall apply to such plan to the maximum 1096
extent that (1) is permitted by federal law, and (2) does not disqualify 1097
such account for the deduction allowed under said Section 220 or 223, 1098
as applicable. 1099
Sec. 23. (NEW) (Effective October 1, 2025) (a) Any pharmacy benefits 1100
manager shall owe a fiduciary duty to any health carrier, as defined in 1101
section 38a-591a of the general statutes, or other health benefit plan 1102
sponsor. 1103
(b) Any pharmacy benefits manager shall notify the health carrier or 1104
other health benefit plan sponsor, in writing, of any activity, policy or 1105
practice of such pharmacy benefits manager that directly or indirectly 1106
presents any conflict of interest with the duties imposed by this section. 1107
(c) Any pharmacy benefits manager shall have an obligation of good 1108
faith and fair dealing in performing such pharmacy benefits manager's 1109
duties with all parties, including, but not limited to, a health carrier or 1110
other health benefit plan sponsor with whom such pharmacy benefits 1111
manager interacts in the performance of pharmacy benefit management 1112
services. 1113
(d) Notwithstanding any provision of title 38a of the general statutes 1114
and to the maximum extent permitted by applicable law, no contract 1115 Substitute Bill No. 11
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entered into or amended by a health carrier shall contain any provision 1116
that permits or requires any party to such contract to violate the 1117
fiduciary duty that such health carrier owes to such health carrier's 1118
covered persons. 1119
(e) Any violation of the provisions of this section shall constitute a 1120
violation of sections 38a-815 to 38a-819, inclusive, of the general statutes. 1121
(f) The Insurance Commissioner may adopt regulations, in 1122
accordance with the provisions of chapter 54 of the general statutes, to 1123
implement the provisions of this section. 1124
Sec. 24. Section 38a-477cc of the general statutes is repealed and the 1125
following is substituted in lieu thereof (Effective January 1, 2026): 1126
(a) No contract for pharmacy services entered into in the state 1127
between a health carrier, as defined in section 38a-591a, or pharmacy 1128
benefits manager, as defined in section 38a-479aaa, and a pharmacy or 1129
pharmacist shall: 1130
(1) On and after January 1, 2018, contain a provision prohibiting or 1131
penalizing, including through increased utilization review, reduced 1132
payments or other financial disincentives, a pharmacist's disclosure to 1133
an individual purchasing prescription medication of information 1134
regarding: 1135
(A) The cost of the prescription medication to the individual; or 1136
(B) The availability of any therapeutically equivalent alternative 1137
medications or alternative methods of purchasing the prescription 1138
medication, including, but not limited to, paying a cash price, that are 1139
less expensive than the cost of the prescription medication to the 1140
individual; [and] 1141
(2) On and after January 1, 2020, contain a provision permitting the 1142
health carrier or pharmacy benefits manager to recoup, directly or 1143
indirectly, from a pharmacy or pharmacist any portion of a claim that 1144
such health carrier or pharmacy benefits manager has paid to the 1145 Substitute Bill No. 11
LCO 5928 38 of 52
pharmacy or pharmacist, unless such recoupment is permitted under 1146
section 38a-479iii or required by applicable law; 1147
(3) On and after January 1, 2026, contain a provision permitting the 1148
pharmacy benefits manager to charge a health benefit plan in this state 1149
a contracted price for any pharmacy services that differs from the 1150
amount such pharmacy benefits manager, directly or indirectly, pays 1151
the pharmacy for such pharmacy services; and 1152
(4) On and after January 1, 2026, contain a provision permitting the 1153
pharmacy benefits manager to charge a health benefit plan, directly or 1154
indirectly, a fee that is conditioned on the (A) wholesale acquisition cost 1155
or any other price metric for a prescription drug, (B) amount of savings, 1156
rebates or other fees charged, realized, collected by or generated based 1157
on the business practices of such pharmacy benefits manager, or (C) 1158
amount of premiums charged or cost-sharing requirements pursuant to 1159
such health benefit plan that are realized or collected by such pharmacy 1160
benefits manager from covered persons. For the purposes of this 1161
subdivision, "wholesale acquisition cost" means the price of a 1162
medication set by a pharmaceutical manufacturer in the United States 1163
when selling to a wholesaler. 1164
(b) (1) On and after January 1, 2018, no health carrier or pharmacy 1165
benefits manager shall require an individual to make a payment at the 1166
point of sale for a covered prescription medication in an amount greater 1167
than the lesser of: 1168
(A) The applicable copayment for such prescription medication; 1169
(B) The allowable claim amount for the prescription medication; or 1170
(C) The amount an individual would pay for the prescription 1171
medication if the individual purchased the prescription medication 1172
without using a health benefit plan, as defined in section 38a-591a, or 1173
any other source of prescription medication benefits or discounts. 1174
(2) For the purposes of this subsection, "allowable claim amount" 1175 Substitute Bill No. 11
LCO 5928 39 of 52
means the amount the health carrier or pharmacy benefits manager has 1176
agreed to pay the pharmacy for the prescription medication. 1177
(c) Any provision of a contract that violates the provisions of this 1178
section shall be void and unenforceable. Any general business practice 1179
that violates the provisions of this section shall constitute an unfair trade 1180
practice pursuant to chapter 735a. The invalidity or unenforceability of 1181
any contract provision under this subsection shall not affect any other 1182
provision of the contract. 1183
(d) The Insurance Commissioner may: 1184
(1) Enforce the provisions of this section pursuant to chapter 697; and 1185
(2) Upon request, audit a contract for pharmacy services for 1186
compliance with the provisions of this section. 1187
Sec. 25. (NEW) (Effective July 1, 2025) (a) The Insurance Commissioner 1188
shall require any health carrier, as defined in section 38a-591a of the 1189
general statutes, to report to the commissioner annually on pricing 1190
offered to and profit generated between such carrier and any pharmacy 1191
benefits manager or mail-order pharmacy doing business with such 1192
carrier. 1193
(b) The commissioner shall post a link on the Internet web site of the 1194
Insurance Department to the reports filed pursuant to subsection (a) of 1195
this section. 1196
Sec. 26. (Effective July 1, 2025) For the purposes of this section and 1197
sections 27 to 35, inclusive, of this act, unless the context otherwise 1198
requires: 1199
(1) "Canadian supplier" means a manufacturer or wholesale drug 1200
distributor that is licensed or permitted under applicable Canadian law 1201
to manufacture or distribute prescription drugs; 1202
(2) "Canadian prescription drug importation program" or "program" 1203
means a program under which the state would seek federal approval to 1204 Substitute Bill No. 11
LCO 5928 40 of 52
import prescription drugs from Canada that have the highest potential 1205
for cost savings in the state; 1206
(3) "Department" means the Department of Consumer Protection; 1207
(4) "Drug" means an article that is (A) recognized in the official United 1208
States Pharmacopoeia, official Homeopathic Pharmacopoeia of the 1209
United States or official National Formulary, or any supplement thereto, 1210
(B) intended for use in the diagnosis, cure, mitigation, treatment or 1211
prevention of disease in humans, (C) not food and intended to affect the 1212
structure or any function of the human body, and (D) not a device and 1213
intended for use as a component of any article specified in 1214
subparagraphs (A) to (C), inclusive, of this subdivision; 1215
(5) "Drug Quality and Security Act" means the federal Drug Quality 1216
and Security Act, 21 USC 351, et seq., as amended from time to time; 1217
(6) "Food, Drug and Cosmetic Act" means the federal Food, Drug and 1218
Cosmetic Act, 21 USC 301, et seq., as amended by the Drug Quality and 1219
Security Act, as both may be amended from time to time; 1220
(7) "Qualifying laboratory" has the same meaning as provided in 21 1221
CFR 251.2; 1222
(8) "Laboratory testing" means a quantitative and qualitative analysis 1223
of a drug consistent with the applicable provisions of the official United 1224
States Pharmacopoeia; 1225
(9) "Participating Canadian supplier" means a Canadian supplier that 1226
is exporting prescription drugs, in the manufacturer's original 1227
container, to a participating wholesaler for distribution in this state 1228
under the program; 1229
(10) "Participating wholesaler" means a wholesaler that is (A) 1230
designated by the Department of Consumer Protection to distribute 1231
prescription drugs in the manufacturer's original container, obtained 1232
from a participating Canadian supplier, and (B) participating in the 1233
program; 1234 Substitute Bill No. 11
LCO 5928 41 of 52
(11) "Recall" means a person's removal or correction of a marketed 1235
product that the department determines is in violation of this section, 1236
but "recall" does not include a market withdrawal or a stock recovery, 1237
as such terms are defined in 21 CFR 7.3; 1238
(12) "Relabeler" has the same meaning as provided in 21 CFR 207.1; 1239
(13) "Repacker" has the same meaning as provided in 21 CFR 207.1; 1240
(14) "Track-and-trace" means the product tracing process for the 1241
components of the pharmaceutical distribution supply chain as 1242
described in Title II of the Drug Quality and Security Act; and 1243
(15) "Wholesaler" means a wholesaler, as defined in section 21a-70 of 1244
the general statutes, that has received a certificate of registration from 1245
the Commissioner of Consumer Protection pursuant to said section. 1246
Sec. 27. (Effective July 1, 2025) The Commissioner of Consumer 1247
Protection shall hire, within available resources, a consultant to study 1248
the feasibility of establishing a Canadian prescription drug importation 1249
program to reduce prescription drug costs in the state. Not later than 1250
October 1, 2027, the commissioner shall file a report, in accordance with 1251
the provisions of section 11-4a of the general statutes, with the joint 1252
standing committees of the General Assembly having cognizance of 1253
matters relating to appropriations and the budgets of state agencies, 1254
general law and human services and the Office of Policy and 1255
Management on the results of the feasibility study. 1256
Sec. 28. (Effective October 1, 2027) (a) If after completion of the study 1257
described in section 27 of this act, the Commissioner of Consumer 1258
Protection, in consultation with the Secretary of the Office of Policy and 1259
Management, determines a Canadian prescription drug importation 1260
program is feasible, the Commissioner of Consumer Protection may 1261
submit a request to the federal Food and Drug Administration seeking 1262
approval for the program under Section 804 of the federal Food, Drug 1263
and Cosmetic Act, 21 USC 384(b) to 21 USC 384(h), inclusive, as 1264
amended from time to time. If submitted, such request shall, at a 1265 Substitute Bill No. 11
LCO 5928 42 of 52
minimum: 1266
(1) Describe the state's plans for operating the program and describe 1267
any opportunities to coordinate or operate the program in coordination 1268
with other states; 1269
(2) Demonstrate that any prescription drug that is imported and 1270
distributed in this state under the program would: 1271
(A) Meet all applicable federal and state standards for safety and 1272
effectiveness; and 1273
(B) Comply with all federal tracing procedures; and 1274
(3) State the estimated costs of implementing the program. 1275
(b) If the federal Food and Drug Administration approves the 1276
request, the Commissioner of Consumer Protection shall: 1277
(1) Submit to the Secretary of the Office of Policy and Management, 1278
and the Commissioners of Social Services and Health Strategy, a notice 1279
disclosing that the federal Food and Drug Administration approved 1280
such request; and 1281
(2) Submit to the joint standing committees of the General Assembly 1282
having cognizance of matters relating to appropriations and the budgets 1283
of state agencies, general law, human services and public health a notice 1284
disclosing that the federal Food and Drug Administration approved 1285
such request. 1286
(c) The Commissioner of Consumer Protection shall not operate the 1287
program unless the federal Food and Drug Administration approves the 1288
request. Notwithstanding the provisions of this subsection, the 1289
department may expend resources in advance of such approval to 1290
ensure efficient implementation. 1291
Sec. 29. (Effective October 1, 2027) If the Canadian prescription drug 1292
importation program is established, each participating wholesaler may 1293 Substitute Bill No. 11
LCO 5928 43 of 52
import and distribute a prescription drug in this state from a 1294
participating Canadian supplier under the program if: 1295
(1) Such drug meets the federal Food and Drug Administration's 1296
standards concerning drug safety, effectiveness, misbranding and 1297
adulteration; 1298
(2) Importing such drug would not violate federal patent laws; and 1299
(3) Such drug is not: 1300
(A) A controlled substance, as defined in 21 USC 802, as amended 1301
from time to time; 1302
(B) A biological product, as defined in 42 USC 262, as amended from 1303
time to time; 1304
(C) An infused drug; 1305
(D) An intravenously injected drug; 1306
(E) A drug that is inhaled during surgery; or 1307
(F) A drug that is a parenteral drug, the importation of which is 1308
determined by the federal Secretary of Health and Human Services to 1309
pose a threat to the public health. 1310
Sec. 30. (Effective October 1, 2027) If a Canadian prescription drug 1311
importation program is established, participating wholesalers may, 1312
subject to the provisions of sections 31 and 32 of this act, import and 1313
distribute drugs in this state from a participating Canadian supplier 1314
under the program to: 1315
(1) A pharmacy or institutional pharmacy, as defined in section 20-1316
571 of the general statutes; and 1317
(2) A qualifying laboratory. 1318
Sec. 31. (Effective October 1, 2027) If a Canadian prescription drug 1319 Substitute Bill No. 11
LCO 5928 44 of 52
importation program is established, the Commissioner of Consumer 1320
Protection shall require that each participating Canadian supplier and 1321
participating wholesaler (1) comply with all applicable track-and-trace 1322
requirements, and shall not distribute, dispense or sell outside of this 1323
state any prescription drug that is imported into this state under the 1324
program, and (2) make available to the commissioner all track-and-trace 1325
records not later than forty-eight hours after the commissioner requests 1326
such records. 1327
Sec. 32. (Effective October 1, 2027) (a) A participating wholesaler in any 1328
approved Canadian prescription drug importation program shall 1329
ensure the safety and quality of all drugs that may be imported and 1330
distributed in this state under the program. The participating 1331
wholesaler shall, if such program is established: 1332
(1) For each initial shipment of a drug that is imported into this state 1333
by a participating wholesaler, ensure that a qualifying laboratory 1334
engaged by the participating wholesaler tests a statistically valid sample 1335
size for each batch of each drug in such shipment for authenticity and 1336
degradation in a manner that is consistent with the Food, Drug and 1337
Cosmetic Act; 1338
(2) For each shipment of a drug that is imported into this state by a 1339
participating wholesaler and has been sampled and tested pursuant to 1340
subdivision (1) of this subsection, ensure that a qualifying laboratory 1341
engaged by the participating wholesaler tests a statistically valid sample 1342
of such shipment for authenticity and degradation in a manner that is 1343
consistent with the Food, Drug and Cosmetic Act; 1344
(3) Only import drugs into this state that are (A) approved for 1345
marketing in the United States, (B) not adulterated or misbranded, and 1346
(C) meet all of the labeling requirements under 21 USC 352, as amended 1347
from time to time; 1348
(4) Maintain qualifying laboratory records, including, but not limited 1349
to, complete data derived from all tests necessary to ensure that each 1350
drug imported into this state under any approved Canadian 1351 Substitute Bill No. 11
LCO 5928 45 of 52
prescription drug importation program is in compliance with the 1352
requirements of this section; and 1353
(5) Maintain documentation demonstrating that the testing required 1354
by this section was conducted at a qualifying laboratory in accordance 1355
with the Food, Drug and Cosmetic Act and all other applicable federal 1356
and state laws and regulations concerning qualifying laboratory 1357
qualifications. 1358
(b) The participating wholesaler shall maintain all information and 1359
documentation pursuant to this section for a period of not less than three 1360
years from the date of submission of such information and 1361
documentation to the participating wholesaler by a qualifying 1362
laboratory. 1363
(c) Each participating wholesaler shall maintain all of the following 1364
information for each drug that such participating wholesaler imports 1365
and distributes in this state under the program, and submit such 1366
information to the Commissioner of Consumer Protection upon request 1367
by the commissioner: 1368
(1) The name and quantity of the active ingredient of such drug; 1369
(2) A description of the dosage form of such drug; 1370
(3) The date on which such participating wholesaler received such 1371
drug; 1372
(4) The quantity of such drug that such participating wholesaler 1373
received; 1374
(5) The point of origin and destination of such drug; 1375
(6) The price paid by such participating wholesaler for such drug; 1376
(7) A report regarding any drug that fails qualifying laboratory 1377
testing; and 1378
(8) Such additional information and documentation that the 1379 Substitute Bill No. 11
LCO 5928 46 of 52
commissioner deems necessary to ensure the protection of the public 1380
health. 1381
(d) The Commissioner of Consumer Protection shall require each 1382
participating Canadian supplier in any approved Canadian prescription 1383
drug importation program to maintain the following information and 1384
documentation and, upon request by the commissioner, submit such 1385
information and documentation to the commissioner for each drug that 1386
such participating Canadian supplier exports into this state under the 1387
program: 1388
(1) The original source of such drug, including, but not limited to: 1389
(A) The name of the manufacturer of such drug; 1390
(B) The date on which such drug was manufactured; and 1391
(C) The location where such drug was manufactured; 1392
(2) The date on which such drug was shipped; 1393
(3) The quantity of such drug that was shipped; 1394
(4) The quantity of each lot of such drug originally received and the 1395
source of such lot; 1396
(5) The lot or control number and the batch number assigned to such 1397
drug by the manufacturer; and 1398
(6) Such additional information and documentation that the 1399
Commissioner of Consumer Protection deems necessary to ensure the 1400
protection of the public health. 1401
Sec. 33. (Effective October 1, 2027) (a) If the Commissioner of Consumer 1402
Protection determines that public health, safety or welfare requires 1403
emergency action, the commissioner may order a participating 1404
Canadian supplier, participating wholesaler, relabeler, repacker and 1405
qualifying laboratory to cease and desist from actions specified in the 1406
order that create the need for such emergency action pending 1407 Substitute Bill No. 11
LCO 5928 47 of 52
administrative proceedings. Such cease and desist order shall be (1) in 1408
writing; (2) signed by the Commissioner of Consumer Protection; and 1409
(3) effective upon delivery to the respondent. An administrative 1410
proceeding in accordance with chapter 54 of the general statutes shall 1411
be promptly instituted following a cease and desist order. The 1412
commissioner may impose a civil penalty, in an amount not to exceed 1413
ten thousand dollars, after a hearing conducted pursuant to chapter 54 1414
of the general statutes. 1415
(b) The commissioner may require the recall, embargo or destruction, 1416
pursuant to section 21a-96 of the general statutes, of any drug that was 1417
imported and distributed under the program and has been identified as 1418
adulterated, within the meaning of section 21a-105 of the general 1419
statutes, or misbranded. 1420
(c) In the event of a cease and desist, recall, embargo or destruction 1421
order, the person adversely impacted by such order shall provide 1422
written notice to all other businesses participating in the program, 1423
informing them of the order. 1424
Sec. 34. (Effective October 1, 2027) If a Canadian prescription drug 1425
importation program is established, the Commissioner of Consumer 1426
Protection may adopt regulations in accordance with the provisions of 1427
chapter 54 of the general statutes to implement the provisions of sections 1428
29 to 33, inclusive, of this act. 1429
Sec. 35. (Effective October 1, 2027) Not later than one hundred eighty 1430
days after the first importation of any Canadian prescription drug under 1431
the importation program begins, and biannually thereafter, the 1432
Commissioner of Consumer Protection shall submit a report, in 1433
accordance with the provisions of section 11-4a of the general statutes, 1434
to the joint standing committees of the General Assembly having 1435
cognizance of matters relating to appropriations and the budgets of state 1436
agencies, general law, human services and public health. Such report 1437
shall describe (1) the operation of the program, if established, and (2) 1438
any violation of sections 29 to 33, inclusive, of this act that resulted in 1439 Substitute Bill No. 11
LCO 5928 48 of 52
any action taken by the commissioner pursuant to section 33 of this act 1440
and the status of the investigation into such violation. 1441
Sec. 36. (NEW) (Effective from passage) (a) There is established a task 1442
force to study emergency preparedness and mitigation strategies for 1443
prescription drug shortages. The task force shall identify prescription 1444
drugs at risk of shortage in this state and make recommendations 1445
pursuant to subsection (g) of this section. 1446
(b) The task force shall consist of the following members: 1447
(1) Two appointed by the speaker of the House of Representatives, 1448
one of whom has expertise in prescription drug supply chains and one 1449
of whom has expertise in federal law concerning prescription drug 1450
shortages; 1451
(2) Two appointed by the president pro tempore of the Senate, one of 1452
whom represents hospitals and one of whom represents health care 1453
providers who treat patients with rare diseases; 1454
(3) One appointed by the majority leader of the House of 1455
Representatives, who represents one of the two federally recognized 1456
Indian tribes in the state; 1457
(4) One appointed by the majority leader of the Senate, who 1458
represents one of the two federally recognized Indian tribes in the state; 1459
(5) One appointed by the minority leader of the House of 1460
Representatives; 1461
(6) One appointed by the minority leader of the Senate; 1462
(7) The Commissioner of Health Strategy, or the commissioner's 1463
designee; 1464
(8) The Commissioner of Consumer Protection, or the commissioner's 1465
designee; 1466
(9) The Commissioner of Social Services, or the commissioner's 1467 Substitute Bill No. 11
LCO 5928 49 of 52
designee; 1468
(10) The Commissioner of Public Health, or the commissioner's 1469
designee; 1470
(11) The chief executive officer of The University of Connecticut 1471
Health Center, or the chief executive officer's designee; 1472
(12) The Insurance Commissioner, or the commissioner's designee; 1473
and 1474
(13) The Commissioner of Economic and Community Development, 1475
or the commissioner's designee. 1476
(c) Any member of the task force appointed under subdivision (1), 1477
(2), (3), (4), (5) or (6) of subsection (b) of this section may be a member 1478
of the General Assembly. 1479
(d) All initial appointments to the task force shall be made not later 1480
than thirty days after the effective date of this section. Any vacancy shall 1481
be filled by the appointing authority. 1482
(e) The speaker of the House of Representatives and the president pro 1483
tempore of the Senate shall select the chairpersons of the task force from 1484
among the members of the task force. Such chairpersons shall schedule 1485
the first meeting of the task force, which shall be held not later than sixty 1486
days after the effective date of this section. 1487
(f) The administrative staff of the joint standing committee of the 1488
General Assembly having cognizance of matters relating to human 1489
services shall serve as administrative staff of the task force. 1490
(g) Not later than January 1, 2026, and annually thereafter, the task 1491
force shall submit a report on its findings and recommendations to the 1492
joint standing committees of the General Assembly having cognizance 1493
of matters relating to general law, human services, insurance and real 1494
estate and public health, in accordance with the provisions of section 11-1495
4a of the general statutes, including, but not limited to, identification of 1496 Substitute Bill No. 11
LCO 5928 50 of 52
prescription drugs the task force determines are at risk of shortage and 1497
strategies that would mitigate these shortages, including methods to 1498
increase in-state production of such drugs deemed both at risk of 1499
shortage and critically necessary for the provision of health care within 1500
the state. 1501
Sec. 37. (NEW) (Effective July 1, 2025) (a) As used in this section, 1502
"Strategic Supply Chain Initiative" means a program administered by 1503
the Department of Economic and Community Development to help 1504
state-based companies to increase their production capacity to win new 1505
business and attract out-of-state and international supply chain 1506
operations. 1507
(b) The Commissioner of Economic and Community Development 1508
shall expand the Strategic Supply Chain Initiative to include efforts to 1509
prevent or mitigate prescription drug shortages, including, but not 1510
limited to, incorporating recommendations to prevent or mitigate 1511
prescription drug shortages by the task force established pursuant to 1512
section 36 of this act. 1513
Sec. 38. (NEW) (Effective from passage) (a) The Commissioner of Public 1514
Health shall establish and convene a Vaccines and Related Biological 1515
Products Advisory Committee for the purpose of coordinating seasonal 1516
vaccine production in coordination with pharmaceutical drug 1517
manufacturers. 1518
(b) The commissioner shall appoint to the advisory committee 1519
representatives of (1) pharmaceutical manufacturers, including one 1520
large such manufacturer and one small or start-up such manufacturer; 1521
(2) health systems, including, but not limited to, one large or state-wide 1522
hospital system and one federally qualified health center; and (3) 1523
physicians, including, but not limited to, one expert each in infectious 1524
disease epidemiology, disease ecology, biostatistics or infectious disease 1525
modeling, and an expert in immunology or virology. 1526
(c) The advisory committee shall be appointed and meet not later 1527
than thirty days after the effective date of this act. The chairpersons shall 1528 Substitute Bill No. 11
LCO 5928 51 of 52
be the commissioner, or the commissioner's designee, and a member of 1529
the committee elected by the committee. Any vacancy shall be filled by 1530
the commissioner. 1531
(d) Not later than September 1, 2025, and annually thereafter, the 1532
commissioner shall file a report, in accordance with the provisions of 1533
section 11-4a of the general statutes, with the joint standing committees 1534
of the General Assembly having cognizance of matters relating to 1535
human services and public health on the activities and 1536
recommendations of the advisory committee and impact on state 1537
preparedness for the annual flu season. 1538
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 July 1, 2025 New section
Sec. 4 July 1, 2025 New section
Sec. 5 July 1, 2025 New section
Sec. 6 from passage New section
Sec. 7 July 1, 2025 17b-340d(a)
Sec. 8 July 1, 2025 New section
Sec. 9 July 1, 2025 New section
Sec. 10 January 1, 2026 New section
Sec. 11 January 1, 2026 New section
Sec. 12 January 1, 2026 New section
Sec. 13 from passage New section
Sec. 14 from passage New section
Sec. 15 July 1, 2025 17b-278l
Sec. 16 October 1, 2025 38a-479ttt
Sec. 17 from passage New section
Sec. 18 from passage New section
Sec. 19 July 1, 2025 New section
Sec. 20 January 1, 2026 New section
Sec. 21 January 1, 2026 38a-492d
Sec. 22 January 1, 2026 38a-518d
Sec. 23 October 1, 2025 New section
Sec. 24 January 1, 2026 38a-477cc Substitute Bill No. 11
LCO 5928 52 of 52
Sec. 25 July 1, 2025 New section
Sec. 26 July 1, 2025 New section
Sec. 27 July 1, 2025 New section
Sec. 28 October 1, 2027 New section
Sec. 29 October 1, 2027 New section
Sec. 30 October 1, 2027 New section
Sec. 31 October 1, 2027 New section
Sec. 32 October 1, 2027 New section
Sec. 33 October 1, 2027 New section
Sec. 34 October 1, 2027 New section
Sec. 35 October 1, 2027 New section
Sec. 36 from passage New section
Sec. 37 July 1, 2025 New section
Sec. 38 from passage New section
Statement of Legislative Commissioners:
In Section 2(b)(1), "Commissioner of Consumer Protection" was changed
to "Commissioner of Revenue Services" for accuracy; in Section
2(c)(1)(A)(i), "Commissioner of Consumer Protection" was changed to
"commissioner" for accuracy; in Section 4(a), "section 5" was changed to
"sections 5 and 6" for accuracy; in Sections 4(b) and 6, "executive
director" was changed to "chief executive officer" for accuracy; in Section
5(b), "or section 4 of this act" was inserted for accuracy; in Section 6, the
effective date was changed for accuracy; in Section 6(f), a reference to
"task force" was changed to "council" for consistency; in Section 14(a)(2),
"concerning implementation of the strategic plan developed pursuant to
section 13 of this act" was inserted after "recommendations" for clarity;
in Section 22(d), the statutory citation was changed for accuracy; in
Section 23(e), "the Connecticut Unfair Insurance Practices Act
established pursuant to section" was changed to "sections 38a-815 to
38a-819, inclusive," for clarity; and in Section 28(c), "foregoing" was
changed to "provisions of this subsection" for consistency with standard
drafting conventions.
HS Joint Favorable Subst.