LCO 1 of 16 General Assembly Substitute Bill No. 7192 January Session, 2025 AN ACT IMPLEMENTING RECOMMENDATIONS OF THE BIPARTISAN DRUG TASK FORCE. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. (NEW) (Effective October 1, 2025) (a) Any pharmacy benefits 1 manager shall owe a fiduciary duty to any health carrier, as defined in 2 section 38a-591a of the general statutes, or other health benefit plan 3 sponsor. 4 (b) Any pharmacy benefits manager shall notify the health carrier or 5 other health benefit plan sponsor, in writing, of any activity, policy or 6 practice of such pharmacy benefits manager that directly or indirectly 7 presents any conflict of interest with the duties imposed by this section. 8 (c) Any pharmacy benefits manager shall have an obligation of good 9 faith and fair dealing in performing such pharmacy benefits manager's 10 duties with all parties, including, but not limited to, a health carrier or 11 other health benefit plan sponsor with whom such pharmacy benefits 12 manager interacts in the performance of pharmacy benefit management 13 services. 14 (d) Notwithstanding any provision of title 38a of the general statutes 15 and to the maximum extent permitted by applicable law, no contract 16 entered into or amended after October 1, 2025, by a health carrier shall 17 contain any provision that permits or requires any party to such contract 18 Substitute Bill No. 7192 LCO 2 of 16 to violate the fiduciary duty that such health carrier owes to such health 19 carrier's covered persons. 20 (e) Any violation of the provisions of this section shall constitute a 21 violation of sections 38a-815 to 38a-819, inclusive, of the general statutes. 22 (f) The Insurance Commissioner may adopt regulations, in 23 accordance with the provisions of chapter 54 of the general statutes, to 24 implement the provisions of this section. 25 Sec. 2. Section 38a-477cc of the general statutes is repealed and the 26 following is substituted in lieu thereof (Effective January 1, 2026): 27 (a) No contract for pharmacy services entered into in the state 28 between a health carrier, as defined in section 38a-591a, or pharmacy 29 benefits manager, as defined in section 38a-479aaa, and a pharmacy or 30 pharmacist shall: 31 (1) On and after January 1, 2018, contain a provision prohibiting or 32 penalizing, including through increased utilization review, reduced 33 payments or other financial disincentives, a pharmacist's disclosure to 34 an individual purchasing prescription medication of information 35 regarding: 36 (A) The cost of the prescription medication to the individual; or 37 (B) The availability of any therapeutically equivalent alternative 38 medications or alternative methods of purchasing the prescription 39 medication, including, but not limited to, paying a cash price, that are 40 less expensive than the cost of the prescription medication to the 41 individual; [and] 42 (2) On and after January 1, 2020, contain a provision permitting the 43 health carrier or pharmacy benefits manager to recoup, directly or 44 indirectly, from a pharmacy or pharmacist any portion of a claim that 45 such health carrier or pharmacy benefits manager has paid to the 46 pharmacy or pharmacist, unless such recoupment is permitted under 47 section 38a-479iii or required by applicable law; 48 Substitute Bill No. 7192 LCO 3 of 16 (3) On and after January 1, 2026, contain a provision permitting the 49 pharmacy benefits manager to charge a health benefit plan in this state 50 a contracted price for any pharmacy services that differs from the 51 amount such pharmacy benefits manager, directly or indirectly, pays 52 the pharmacy for such pharmacy services; and 53 (4) On and after January 1, 2026, contain a provision permitting the 54 pharmacy benefits manager to charge a health benefit plan, directly or 55 indirectly, a fee that is conditioned on the (A) wholesale acquisition cost 56 or any other price metric for a prescription drug, (B) amount of savings, 57 rebates or other fees charged, realized, collected by or generated based 58 on the business practices of such pharmacy benefits manager, or (C) 59 amount of premiums charged or cost-sharing requirements pursuant to 60 such health benefit plan that are realized or collected by such pharmacy 61 benefits manager from covered persons. For the purposes of this 62 subdivision, "wholesale acquisition cost" means the price of a 63 medication set by a pharmaceutical manufacturer in the United States 64 when selling to a wholesaler. 65 (b) (1) On and after January 1, 2018, no health carrier or pharmacy 66 benefits manager shall require an individual to make a payment at the 67 point of sale for a covered prescription medication in an amount greater 68 than the lesser of: 69 (A) The applicable copayment for such prescription medication; 70 (B) The allowable claim amount for the prescription medication; or 71 (C) The amount an individual would pay for the prescription 72 medication if the individual purchased the prescription medication 73 without using a health benefit plan, as defined in section 38a-591a, or 74 any other source of prescription medication benefits or discounts. 75 (2) For the purposes of this subsection, "allowable claim amount" 76 means the amount the health carrier or pharmacy benefits manager has 77 agreed to pay the pharmacy for the prescription medication. 78 Substitute Bill No. 7192 LCO 4 of 16 (c) Any provision of a contract that violates the provisions of this 79 section shall be void and unenforceable. Any general business practice 80 that violates the provisions of this section shall constitute an unfair trade 81 practice pursuant to chapter 735a. The invalidity or unenforceability of 82 any contract provision under this subsection shall not affect any other 83 provision of the contract. 84 (d) The Insurance Commissioner may: 85 (1) Enforce the provisions of this section pursuant to chapter 697; and 86 (2) Upon request, audit a contract for pharmacy services for 87 compliance with the provisions of this section. 88 Sec. 3. Section 38a-479ttt of the general statutes is repealed and the 89 following is substituted in lieu thereof (Effective October 1, 2025): 90 Not later than March 1, 2021, and annually thereafter, the 91 commissioner shall prepare a report, for the immediately preceding 92 calendar year, describing the rebate practices of health carriers. The 93 report shall contain (1) an explanation of the manner in which health 94 carriers accounted for rebates in calculating premiums for health care 95 plans delivered, issued for delivery, renewed, amended or continued 96 during such year, (2) a statement disclosing whether, and describing the 97 manner in which, health carriers made rebates available to insureds at 98 the point of purchase during such year, (3) any other manner in which 99 health carriers applied rebates during such year, (4) the percentage of 100 rebate dollars used by health carriers to reduce cost-sharing 101 requirements during such year, (5) an evaluation of rebate practices to 102 reduce cost-sharing for health care plans delivered, issued for delivery, 103 renewed, amended or continued during such year, and [(4)] (6) such 104 other information as the commissioner, in the commissioner's 105 discretion, deems relevant for the purposes of this section. The 106 commissioner shall publish a copy of the report on the department's 107 Internet web site. 108 Sec. 4. (NEW) (Effective July 1, 2025) (a) The Insurance Commissioner 109 Substitute Bill No. 7192 LCO 5 of 16 shall require any health carrier, as defined in section 38a-591a of the 110 general statutes, to report to the commissioner annually on pricing 111 offered to and profit generated between such carrier and any pharmacy 112 benefits manager or mail-order pharmacy doing business with such 113 carrier. 114 (b) The commissioner shall post a link on the Internet web site of the 115 Insurance Department to the reports filed pursuant to subsection (a) of 116 this section. 117 Sec. 5. (Effective July 1, 2025) For the purposes of this section and 118 sections 6 to 14, inclusive, of this act, unless the context otherwise 119 requires: 120 (1) "Canadian supplier" means a manufacturer or wholesale drug 121 distributor that is licensed or permitted under applicable Canadian law 122 to manufacture or distribute prescription drugs; 123 (2) "Canadian prescription drug importation program" or "program" 124 means a program under which the state would seek federal approval to 125 import prescription drugs from Canada that have the highest potential 126 for cost savings in the state; 127 (3) "Department" means the Department of Consumer Protection; 128 (4) "Drug" means an article that is (A) recognized in the official United 129 States Pharmacopoeia, official Homeopathic Pharmacopoeia of the 130 United States or official National Formulary, or any supplement thereto, 131 (B) intended for use in the diagnosis, cure, mitigation, treatment or 132 prevention of disease in humans, (C) not food and intended to affect the 133 structure or any function of the human body, and (D) not a device and 134 intended for use as a component of any article specified in 135 subparagraphs (A) to (C), inclusive, of this subdivision; 136 (5) "Drug Quality and Security Act" means the federal Drug Quality 137 and Security Act, 21 USC 351, et seq., as amended from time to time; 138 (6) "Food, Drug and Cosmetic Act" means the federal Food, Drug and 139 Substitute Bill No. 7192 LCO 6 of 16 Cosmetic Act, 21 USC 301, et seq., as amended by the Drug Quality and 140 Security Act, as both may be amended from time to time; 141 (7) "Qualifying laboratory" has the same meaning as provided in 21 142 CFR 251.2; 143 (8) "Laboratory testing" means a quantitative and qualitative analysis 144 of a drug consistent with the applicable provisions of the official United 145 States Pharmacopoeia; 146 (9) "Participating Canadian supplier" means a Canadian supplier that 147 is exporting prescription drugs, in the manufacturer's original 148 container, to a participating wholesaler for distribution in this state 149 under the program; 150 (10) "Participating wholesaler" means a wholesaler that is (A) 151 designated by the Department of Consumer Protection to distribute 152 prescription drugs in the manufacturer's original container, obtained 153 from a participating Canadian supplier, and (B) participating in the 154 program; 155 (11) "Recall" means a person's removal or correction of a marketed 156 product that the department determines is in violation of this section, 157 but "recall" does not include a market withdrawal or a stock recovery, 158 as such terms are defined in 21 CFR 7.3; 159 (12) "Relabeler" has the same meaning as provided in 21 CFR 207.1; 160 (13) "Repacker" has the same meaning as provided in 21 CFR 207.1; 161 (14) "Track-and-trace" means the product tracing process for the 162 components of the pharmaceutical distribution supply chain as 163 described in Title II of the Drug Quality and Security Act; and 164 (15) "Wholesaler" means a wholesaler, as defined in section 21a-70 of 165 the general statutes, that has received a certificate of registration from 166 the Commissioner of Consumer Protection pursuant to said section. 167 Substitute Bill No. 7192 LCO 7 of 16 Sec. 6. (Effective July 1, 2025) The Commissioner of Consumer 168 Protection shall hire, within available resources, a consultant to study 169 the feasibility of establishing a Canadian prescription drug importation 170 program to reduce prescription drug costs in the state. Not later than 171 October 1, 2027, the commissioner shall file a report, in accordance with 172 the provisions of section 11-4a of the general statutes, with the joint 173 standing committees of the General Assembly having cognizance of 174 matters relating to appropriations and the budgets of state agencies, 175 general law and human services and the Office of Policy and 176 Management on the results of the feasibility study. 177 Sec. 7. (Effective October 1, 2027) (a) If after completion of the study 178 described in section 6 of this act, the Commissioner of Consumer 179 Protection, in consultation with the Secretary of the Office of Policy and 180 Management, determines a Canadian prescription drug importation 181 program is feasible, the Commissioner of Consumer Protection may 182 submit a request to the federal Food and Drug Administration seeking 183 approval for the program under Section 804 of the federal Food, Drug 184 and Cosmetic Act, 21 USC 384(b) to 21 USC 384(h), inclusive, as 185 amended from time to time. If submitted, such request shall, at a 186 minimum: 187 (1) Describe the state's plans for operating the program and describe 188 any opportunities to coordinate or operate the program in coordination 189 with other states; 190 (2) Demonstrate that any prescription drug that is imported and 191 distributed in this state under the program would: 192 (A) Meet all applicable federal and state standards for safety and 193 effectiveness; and 194 (B) Comply with all federal tracing procedures; and 195 (3) State the estimated costs of implementing the program. 196 (b) If the federal Food and Drug Administration approves the 197 Substitute Bill No. 7192 LCO 8 of 16 request, the Commissioner of Consumer Protection shall: 198 (1) Submit to the Secretary of the Office of Policy and Management, 199 and the Commissioners of Social Services and Health Strategy, a notice 200 disclosing that the federal Food and Drug Administration approved 201 such request; and 202 (2) Submit to the joint standing committees of the General Assembly 203 having cognizance of matters relating to appropriations and the budgets 204 of state agencies, general law, human services and public health a notice 205 disclosing that the federal Food and Drug Administration approved 206 such request. 207 (c) The Commissioner of Consumer Protection shall not operate the 208 program unless the federal Food and Drug Administration approves the 209 request. Notwithstanding the provisions of this subsection, the 210 department may expend resources in advance of such approval to 211 ensure efficient implementation. 212 Sec. 8. (Effective October 1, 2027) If the Canadian prescription drug 213 importation program is established, each participating wholesaler may 214 import and distribute a prescription drug in this state from a 215 participating Canadian supplier under the program if: 216 (1) Such drug meets the federal Food and Drug Administration's 217 standards concerning drug safety, effectiveness, misbranding and 218 adulteration; 219 (2) Importing such drug would not violate federal patent laws; and 220 (3) Such drug is not: 221 (A) A controlled substance, as defined in 21 USC 802, as amended 222 from time to time; 223 (B) A biological product, as defined in 42 USC 262, as amended from 224 time to time; 225 Substitute Bill No. 7192 LCO 9 of 16 (C) An infused drug; 226 (D) An intravenously injected drug; 227 (E) A drug that is inhaled during surgery; or 228 (F) A drug that is a parenteral drug, the importation of which is 229 determined by the federal Secretary of Health and Human Services to 230 pose a threat to the public health. 231 Sec. 9. (Effective October 1, 2027) If a Canadian prescription drug 232 importation program is established, participating wholesalers may, 233 subject to the provisions of sections 10 and 11 of this act, import and 234 distribute drugs in this state from a participating Canadian supplier 235 under the program to: 236 (1) A pharmacy or institutional pharmacy, as defined in section 20-237 571 of the general statutes; and 238 (2) A qualifying laboratory. 239 Sec. 10. (Effective October 1, 2027) If a Canadian prescription drug 240 importation program is established, the Commissioner of Consumer 241 Protection shall require that each participating Canadian supplier and 242 participating wholesaler (1) comply with all applicable track-and-trace 243 requirements, and shall not distribute, dispense or sell outside of this 244 state any prescription drug that is imported into this state under the 245 program, and (2) make available to the commissioner all track-and-trace 246 records not later than forty-eight hours after the commissioner requests 247 such records. 248 Sec. 11. (Effective October 1, 2027) (a) A participating wholesaler in any 249 approved Canadian prescription drug importation program shall 250 ensure the safety and quality of all drugs that may be imported and 251 distributed in this state under the program. The participating 252 wholesaler shall, if such program is established: 253 (1) For each initial shipment of a drug that is imported into this state 254 Substitute Bill No. 7192 LCO 10 of 16 by a participating wholesaler, ensure that a qualifying laboratory 255 engaged by the participating wholesaler tests a statistically valid sample 256 size for each batch of each drug in such shipment for authenticity and 257 degradation in a manner that is consistent with the Food, Drug and 258 Cosmetic Act; 259 (2) For each shipment of a drug that is imported into this state by a 260 participating wholesaler and has been sampled and tested pursuant to 261 subdivision (1) of this subsection, ensure that a qualifying laboratory 262 engaged by the participating wholesaler tests a statistically valid sample 263 of such shipment for authenticity and degradation in a manner that is 264 consistent with the Food, Drug and Cosmetic Act; 265 (3) Only import drugs into this state that are (A) approved for 266 marketing in the United States, (B) not adulterated or misbranded, and 267 (C) meet all of the labeling requirements under 21 USC 352, as amended 268 from time to time; 269 (4) Maintain qualifying laboratory records, including, but not limited 270 to, complete data derived from all tests necessary to ensure that each 271 drug imported into this state under any approved Canadian 272 prescription drug importation program is in compliance with the 273 requirements of this section; and 274 (5) Maintain documentation demonstrating that the testing required 275 by this section was conducted at a qualifying laboratory in accordance 276 with the Food, Drug and Cosmetic Act and all other applicable federal 277 and state laws and regulations concerning qualifying laboratory 278 qualifications. 279 (b) The participating wholesaler shall maintain all information and 280 documentation pursuant to this section for a period of not less than three 281 years from the date of submission of such information and 282 documentation to the participating wholesaler by a qualifying 283 laboratory. 284 (c) Each participating wholesaler shall maintain all of the following 285 Substitute Bill No. 7192 LCO 11 of 16 information for each drug that such participating wholesaler imports 286 and distributes in this state under the program, and submit such 287 information to the Commissioner of Consumer Protection upon request 288 by the commissioner: 289 (1) The name and quantity of the active ingredient of such drug; 290 (2) A description of the dosage form of such drug; 291 (3) The date on which such participating wholesaler received such 292 drug; 293 (4) The quantity of such drug that such participating wholesaler 294 received; 295 (5) The point of origin and destination of such drug; 296 (6) The price paid by such participating wholesaler for such drug; 297 (7) A report regarding any drug that fails qualifying laboratory 298 testing; and 299 (8) Such additional information and documentation that the 300 commissioner deems necessary to ensure the protection of the public 301 health. 302 (d) The Commissioner of Consumer Protection shall require each 303 participating Canadian supplier in any approved Canadian prescription 304 drug importation program to maintain the following information and 305 documentation and, upon request by the commissioner, submit such 306 information and documentation to the commissioner for each drug that 307 such participating Canadian supplier exports into this state under the 308 program: 309 (1) The original source of such drug, including, but not limited to: 310 (A) The name of the manufacturer of such drug; 311 (B) The date on which such drug was manufactured; and 312 Substitute Bill No. 7192 LCO 12 of 16 (C) The location where such drug was manufactured; 313 (2) The date on which such drug was shipped; 314 (3) The quantity of such drug that was shipped; 315 (4) The quantity of each lot of such drug originally received and the 316 source of such lot; 317 (5) The lot or control number and the batch number assigned to such 318 drug by the manufacturer; and 319 (6) Such additional information and documentation that the 320 Commissioner of Consumer Protection deems necessary to ensure the 321 protection of the public health. 322 Sec. 12. (Effective October 1, 2027) (a) If the Commissioner of Consumer 323 Protection determines that public health, safety or welfare requires 324 emergency action, the commissioner may order a participating 325 Canadian supplier, participating wholesaler, relabeler, repacker and 326 qualifying laboratory to cease and desist from actions specified in the 327 order that create the need for such emergency action pending 328 administrative proceedings. Such cease and desist order shall be (1) in 329 writing; (2) signed by the Commissioner of Consumer Protection; and 330 (3) effective upon delivery to the respondent. An administrative 331 proceeding in accordance with chapter 54 of the general statutes shall 332 be promptly instituted following a cease and desist order. The 333 commissioner may impose a civil penalty, in an amount not to exceed 334 ten thousand dollars, after a hearing conducted pursuant to chapter 54 335 of the general statutes. 336 (b) The commissioner may require the recall, embargo or destruction, 337 pursuant to section 21a-96 of the general statutes, of any drug that was 338 imported and distributed under the program and has been identified as 339 adulterated, within the meaning of section 21a-105 of the general 340 statutes, or misbranded. 341 (c) In the event of a cease and desist, recall, embargo or destruction 342 Substitute Bill No. 7192 LCO 13 of 16 order, the person adversely impacted by such order shall provide 343 written notice to all other businesses participating in the program, 344 informing them of the order. 345 Sec. 13. (Effective October 1, 2027) If a Canadian prescription drug 346 importation program is established, the Commissioner of Consumer 347 Protection may adopt regulations in accordance with the provisions of 348 chapter 54 of the general statutes to implement the provisions of sections 349 5 to 12, inclusive, of this act. 350 Sec. 14. (Effective October 1, 2027) Not later than one hundred eighty 351 days after the first importation of any Canadian prescription drug under 352 the importation program begins, and biannually thereafter, the 353 Commissioner of Consumer Protection shall submit a report, in 354 accordance with the provisions of section 11-4a of the general statutes, 355 to the joint standing committees of the General Assembly having 356 cognizance of matters relating to appropriations and the budgets of state 357 agencies, general law, human services and public health. Such report 358 shall describe (1) the operation of the program, if established, and (2) 359 any violation of sections 5 to 13, inclusive, of this act that resulted in any 360 action taken by the commissioner pursuant to section 12 of this act and 361 the status of the investigation into such violation. 362 Sec. 15. (NEW) (Effective from passage) (a) There is established a task 363 force to study emergency preparedness and mitigation strategies for 364 prescription drug shortages. The task force shall identify prescription 365 drugs at risk of shortage in this state and make recommendations 366 pursuant to subsection (g) of this section. 367 (b) The task force shall consist of the following members: 368 (1) Two appointed by the speaker of the House of Representatives, 369 one of whom has expertise in prescription drug supply chains and one 370 of whom has expertise in federal law concerning prescription drug 371 shortages; 372 (2) Two appointed by the president pro tempore of the Senate, one of 373 Substitute Bill No. 7192 LCO 14 of 16 whom represents hospitals and one of whom represents health care 374 providers who treat patients with rare diseases; 375 (3) One appointed by the majority leader of the House of 376 Representatives, who represents one of the two federally recognized 377 Indian tribes in the state; 378 (4) One appointed by the majority leader of the Senate, who 379 represents one of the two federally recognized Indian tribes in the state; 380 (5) One appointed by the minority leader of the House of 381 Representatives; 382 (6) One appointed by the minority leader of the Senate; 383 (7) The Commissioner of Health Strategy, or the commissioner's 384 designee; 385 (8) The Commissioner of Consumer Protection, or the commissioner's 386 designee; 387 (9) The Commissioner of Social Services, or the commissioner's 388 designee; 389 (10) The Commissioner of Public Health, or the commissioner's 390 designee; 391 (11) The chief executive officer of The University of Connecticut 392 Health Center, or the chief executive officer's designee; 393 (12) The Insurance Commissioner, or the commissioner's designee; 394 and 395 (13) The Commissioner of Economic and Community Development, 396 or the commissioner's designee. 397 (c) Any member of the task force appointed under subdivision (1), 398 (2), (3), (4), (5) or (6) of subsection (b) of this section may be a member 399 of the General Assembly. 400 Substitute Bill No. 7192 LCO 15 of 16 (d) All initial appointments to the task force shall be made not later 401 than thirty days after the effective date of this section. Any vacancy shall 402 be filled by the appointing authority. 403 (e) The speaker of the House of Representatives and the president pro 404 tempore of the Senate shall select the chairpersons of the task force from 405 among the members of the task force. Such chairpersons shall schedule 406 the first meeting of the task force, which shall be held not later than sixty 407 days after the effective date of this section. 408 (f) The administrative staff of the joint standing committee of the 409 General Assembly having cognizance of matters relating to general law 410 shall serve as administrative staff of the task force. 411 (g) Not later than January 1, 2026, and annually thereafter, the task 412 force shall submit a report on its findings and recommendations to the 413 joint standing committees of the General Assembly having cognizance 414 of matters relating to general law, human services, insurance and real 415 estate and public health, in accordance with the provisions of section 11-416 4a of the general statutes, including, but not limited to, identification of 417 prescription drugs the task force determines are at risk of shortage and 418 strategies that would mitigate these shortages, including methods to 419 increase in-state production of such drugs deemed both at risk of 420 shortage and critically necessary for the provision of health care within 421 the state. 422 Sec. 16. (NEW) (Effective July 1, 2025) (a) As used in this section, 423 "Strategic Supply Chain Initiative" means a program administered by 424 the Department of Economic and Community Development to help 425 state-based companies to increase their production capacity to win new 426 business and attract out-of-state and international supply chain 427 operations. 428 (b) The Commissioner of Economic and Community Development 429 shall expand the Strategic Supply Chain Initiative to include efforts to 430 prevent or mitigate prescription drug shortages, including, but not 431 limited to, incorporating recommendations to prevent or mitigate 432 Substitute Bill No. 7192 LCO 16 of 16 prescription drug shortages by the task force established pursuant to 433 section 15 of this act. 434 This act shall take effect as follows and shall amend the following sections: Section 1 October 1, 2025 New section Sec. 2 January 1, 2026 38a-477cc Sec. 3 October 1, 2025 38a-479ttt Sec. 4 July 1, 2025 New section Sec. 5 July 1, 2025 New section Sec. 6 July 1, 2025 New section Sec. 7 October 1, 2027 New section Sec. 8 October 1, 2027 New section Sec. 9 October 1, 2027 New section Sec. 10 October 1, 2027 New section Sec. 11 October 1, 2027 New section Sec. 12 October 1, 2027 New section Sec. 13 October 1, 2027 New section Sec. 14 October 1, 2027 New section Sec. 15 from passage New section Sec. 16 July 1, 2025 New section HS Joint Favorable Subst. -LCO INS Joint Favorable